PLM_Manual Ethicon Wound Closure Manual 101702

User Manual: manual pdf -FilePursuit

Open the PDF directly: View PDF .
Page Count: 125 [warning: Documents this large are best viewed by clicking the View PDF Link!]

WOUND

CLOSURE

MANUAL

CONTRIBUTING EDITOR

David, L. Dunn, M.D., Ph. D.

Jay Phillips Professor and Chairman of Surgery,

University of Minnesota

We thank Dr. Dunn for his contributions to the Wound Closure

Manual. Dr. Dunn is currently the Jay Phillips Professor and

Chairman of Surgery at the University of Minnesota. This

department has a long-standing tradition and has attained

national and international recognition for excellence in training

academic general surgeons and surgical scientists. He is also the

Division Chief of General Surgery, Head of Surgical Infectious

Diseases, Director of Graduate Studies, and Residency Program

Director of the Department of Surgery.

Dr. Dunn has published over 400 articles and book chapters in the

areas of Surgical Infectious Diseases and Transplantation. He has

received regional and nationwide recognition in several

academic organizations and is a Past-President of the Surgical

Infection Society, the Association for Academic Surgery, the

Minnesota Chapter of the American College of Surgeons, the

Society of University Surgeons and the Society of University

Surgeons Foundation.

PREFACE

his manual has been prepared for the medical professional who

would like to learn more about the practice of surgery–the

dynamics of tissue healing, the principles of wound closure, and the

materials available to today’s practitioners. Most important, it

touches on some of the critical decisions which must be made on a

daily basis to help ensure proper wound closure.

ETHICON, INC., a Johnson & Johnson company, is the world’s

leading marketer of surgical sutures and is the only U.S. company

that offers an adhesive with microbial protection as an alternative

to sutures for topical skin closure.

ETHICON enjoys a reputation for developing quality products to

enhance the lives of patients and for providing outstanding service

to customers. We hope you find this manual useful. But, above all,

we hope that it reflects our high regard for the men and women

who have chosen the medical profession as a career.

ETHICON, Inc.

TABLE OF CONTENTS

1WOUND HEALING

AND MANAGEMENT

The Wound.......................................................... 2

Recovery of Tensile Strength............................ 2

Patient Factors that Affect Wound Healing......... 2

Surgical Principles....................................... 4

Classification of Wounds................................... 5

Types of Wound Healing................................... 6

Healing by Primary Intention........................ 6

Healing by Second Intention.......................... 7

Delayed Primary Closure.............................. 7

2THE SUTURE

What is a Suture?............................................... 10

Personal Suture Preference............................... 10

Suture Characteristics....................................... 11

Size and Tensile Strength.............................. 11

Monofilament vs. Multifilament.................... 11

Absorbable vs. Nonabsorbable Sutures.............. 12

Specific Suturing Materials.............................. 13

Synthetic Absorbable Sutures......................... 14

Nonabsorbable Sutures................................ 16

Synthetic Nonabsorbable Sutures.................... 17

Common Suturing Techniques....................... 18

Ligatures................................................. 18

The Primary Suture Line............................. 18

Continuous Sutures.................................... 19

Interrupted Sutures.................................... 19

Deep Sutures............................................ 22

Buried Sutures .......................................... 22

Purse-String Sutures................................... 22

Subcuticular Sutures................................... 22

The Secondary Suture Line........................... 22

Stitch Placement........................................ 23

Knot Tying......................................................... 24

Knot Security............................................ 24

Knot Tying Techniques Most Often Used .......... 25

Square Knot............................................. 25

Surgeon’s or Friction Knot............................ 26

Deep Tie................................................. 26

Ligation Using a Hemostatic Clamp............... 26

Instrument Tie.......................................... 26

Endoscopic Knot Tying Techniques.................. 26

Cutting the Secured Sutures.......................... 26

Suture Removal................................................. 26

Suture Handling Tips....................................... 27

Suture Selection Procedure ............................. 27

Surgery within the Abdominal Wall Cavity....... 28

Closing the Abdomen.................................. 30

Closing Contaminated or Infected Wounds........ 40

3THE SURGICAL NEEDLE

Elements of Needle Design ............................. 42

Principles of Choosing a Surgical Needle..... 43

Anatomy of a Needle........................................ 44

The Needle Eye......................................... 45

The Needle Body....................................... 46

Straight Needle......................................... 46

Half-Curved Needle................................... 46

Curved Needle.......................................... 46

Compound Curved Needle........................... 47

The Needle Point ...................................... 47

Types of Needles............................................... 47

Conventional Cutting Needles....................... 48

Reverse Cutting Needles............................... 49

Side Cutting Needles................................... 49

Taper Point Needles................................... 50

Taper Surgical Needles................................ 50

Blunt Point Needles.................................... 51

Needleholders.................................................... 51

Needleholder Use....................................... 52

Placing the Needle in Tissue ......................... 52

Needle Handling Tips...................................... 54

4PACKAGING

An Integral Part of the Product ..................... 56

Relay* Suture Delivery System....................... 56

Modular Storage Racks................................ 56

Dispenser Boxes......................................... 56

Primary Packets........................................ 57

E-Pack* Procedure Kit..................................... 59

Expiration Date................................................. 60

Suture Sterilization........................................... 60

Anticipating Suture Needs............................... 61

Sterile Transfer of Suture Packets.................... 61

Suture Preparation in the Sterile Field............. 62

Suture Handling Technique.......................... 63

5TOPICAL SKIN ADHESIVES

Dermabond* topical skin adhesive................ 68

6OTHER SURGICAL

PRODUCTS

Adhesive Tapes................................................... 74

Indications and Usage................................. 74

Application.............................................. 74

After Care and Removal.............................. 74

Skin Closure Tapes..................................... 75

Polyester Fiber Strips.................................. 75

Umbilical Tape ........................................ 75

Surgical Staples................................................. 76

Indications and Usage................................. 76

Aftercare and Removal................................ 76

PROXIMATE* Skin Staplers........................ 76

Looped Suture................................................... 77

Retention Suture Devices................................ 77

7PRODUCT TERMS

AND TRADEMARKS

8PRODUCT INFORMATION

9INDEX

WOUND HEALING

AND MANAGEMENT

CHAPTER 1

WOUND HEALING & MANAGEMENT

THE WOUND

Injury to any of the tissues of

the body, especially that caused

by physical means and with

interruption of continuity is defined

as a wound.1Though most often

the result of a physical cause, a

burn is also considered a wound.

Both follow the same processes

towards the restoration to

health – otherwise known

as healing.1

Wound healing is a natural and

spontaneous phenomenon. When

tissue has been disrupted so severely

that it cannot heal naturally

(without complications or possible

disfiguration) dead tissue and

foreign bodies must be removed,

infection treated, and the tissue

must be held in apposition until the

healing process provides the wound

with sufficient strength to withstand

stress without mechanical support.

A wound may be approximated

with sutures, staples, clips, skin

closure strips, or topical adhesives.

Tissue is defined as a collection of

similar cells and the intercellular

substances surrounding them.

There are four basic tissues in the

body: 1) epithelium; 2) connective

tissues, including blood, bone and

cartilage; 3) muscle tissue; and

4) nerve tissue. The choice of

wound closure materials and the

techniques of using them are prime

factors in the restoration of

continuity and tensile strength to

the injured tissues during the

healing process.

The parameters for measuring the

strength of normal body tissue are:

• Tensile Strength—The load per

cross-sectional area unit at the

point of rupture, relating to the

nature of the material rather than

its thickness.

• Breaking Strength—The load

required to break a wound regard-

less of its dimension, the more

clinically significant measurement.

• Burst Strength—The amount of

pressure needed to rupture a

viscus, or large interior organ.

The rate at which wounds regain

strength during the wound healing

process must be understood as a

basis for selecting the most

appropriate wound closure material.

RECOVERY OF

TENSILE STRENGTH

Tensile strength affects the tissue's

ability to withstand injury but is

not related to the length of time it

takes the tissue to heal. As collagen

accumulates during the reparative

phase, strength increases rapidly but

it is many months before a plateau

is reached.2Until this time, the

wound requires extrinsic support

from the method used to bring it

together – usually sutures. While

skin and fascia (the layer of firm

connective tissue covering muscle)

are the strongest tissues in the body,

they regain tensile strength slowly

during the healing process. The

stomach and small intestine, on the

other hand, are composed of much

weaker tissue but heal rapidly.

Variations in tissue strength may

also be found within the same

organ. Within the colon, for

example, the sigmoid region is

approximately twice as strong as the

cecum—but both sections heal at

the same rate. Factors that affect

tissue strength include the size, age,

and weight of the patient, the

thickness of tissue, the presence of

edema, and duration (the degree to

which the tissue has hardened in

response to pressure or injury).

PATIENT FACTORS THAT

AFFECT WOUND HEALING

The goal of wound management

is to provide interventions that

efficiently progress wounds through

the biologic sequence of repair or

regeneration. The patient's overall

health status will affect the speed of

the healing process. The following

are factors that should be considered

by the surgical team prior to and

during the procedure. 2,3,4

✦AGE — With aging, both skin

and muscle tissue lose their tone

and elasticity. Metabolism also

slows, and circulation may be

impaired. But aging alone is not

a major factor in chronic wound

healing. Aging and chronic

disease states often go together,

and both delay repair processes

due to delayed cellular response

to the stimulus of injury, delayed

collagen deposition, and

decreased tensile strength in the

remodeled tissue. All of these

factors lengthen healing time.

✦WEIGHT — Obese patients

of any age have, excess fat at the

wound site that may prevent

securing a good closure. In

addition, fat does not have a rich

blood supply, making it the most

vulnerable of all tissues to trauma

and infection.

✦NUTRITIONAL STATUS —

Overall malnutrition associated

with chronic disease or cancer,

or specific deficiencies in

carbohydrates, proteins, zinc, and

vitamins A, B, and C can impair

the healing process. Adequate

nutrition is essential to support

cellular activity and collagen

synthesis at the wound site.

✦DEHYDRATION — If the

patient's system has been

depleted of fluids, the resulting

electrolyte imbalance can affect

cardiac function, kidney

function, cellular metabolism,

oxygenation of the blood, and

hormonal function. These effects

will not only impact upon the

patient's overall health status and

recovery from surgery but may

also impair the healing process.

✦INADEQUATE BLOOD

SUPPLY TO THE WOUND

SITE — Oxygen is necessary for

cell survival and, therefore,

healing. Skin healing takes place

most rapidly in the face and

neck, which receive the greatest

blood supply, and most slowly in

the extremities. The presence of

any condition that compromises

the supply of blood to the

wound, such as poor circulation

to the limbs in a diabetic patient

or arteriosclerosis with vascular

compromise, will slow and can

even arrest the healing process.

✦IMMUNE RESPONSES —

Because the immune response

protects the patient from

infection, immunodeficiencies

may seriously compromise the

outcome of a surgical procedure.

Patients infected with HIV, as

well as those who have recently

undergone chemotherapy or who

have taken prolonged high

dosages of catabolic steroids, may

have debilitated immune systems.

Some patients have allergies to

specific suturing materials, metal

alloys, or latex. These, on the

other hand, will cause a height-

ened immune response in the

form of an allergic reaction.

This may also interfere with the

healing process. Therefore,

the surgeon should always

check beforehand on a

patient's allergies.

✦CHRONIC DISEASE —

A patient whose system has

already been stressed by chronic

illness, especially endocrine

disorders, diabetes, malignancies,

localized infection, or debilitating

injuries will heal more slowly and

will be more vulnerable to post

surgical wound complications.

All of these conditions merit

concern, and the surgeon must

consider their effects upon the

tissues at the wound site, as well

as their potential impact upon

the patient's overall recovery

from the procedure.

Malignancies, in addition, may

alter the cellular structure of

tissue and influence the

surgeon's choice of methods and

closure materials.

✦RADIATION THERAPY —

Radiation therapy to the surgical

site prior to or shortly after

surgery can produce considerable

impairment of healing and lead

to substantial wound complica-

tions. Surgical procedures for

malignancies must be planned

to minimize the potential for

these problems.

CHAPTER 1 3

* Trademark

RELATIVE

TISSUE

STRENGTH

Stomach

(Weak)

Small

intestine

(Weak)

Female

reproductive

organs

(Weak)

Bladder

(Weak)

Lower

respiratory

tract (Weak)

Duodenum

(Strong)

Cecum

(Weak)

Ileum

(Weak)

FIGURE

SURGICAL PRINCIPLES

Many factors that affect the healing

process can be controlled by the

surgical team in the operating room,

by the obstetrical team in labor and

delivery, or by the emergency team

in the trauma center. Their first

priority is to maintain a sterile

and aseptic technique to prevent

infection. Organisms found

within a patient's own body most

commonly cause postoperative

infection, but microorganisms

carried by medical personnel also

pose a threat. Whatever the source,

the presence of infection will deter

healing. In addition to concerns

about sterility, the following must

be taken into consideration when

planning and carrying out an

operative procedure.3

✦THE LENGTH AND

DIRECTION OF THE

INCISION — A properly

planned incision is sufficiently

long to afford sufficient optimum

exposure. When deciding upon

the direction of the incision, the

surgeon must bear the following

in mind:

• The direction in which wounds

naturally heal is from side-to-

side, not end-to-end.

• The arrangement of tissue fibers

in the area to be dissected will

vary with tissue type.

• The best cosmetic results may be

achieved when incisions are made

parallel to the direction of the

tissue fibers. Results may vary

depending upon the tissue

layer involved.

✦DISSECTION

TECHNIQUE — When incising

tissue, a clean incision should

be made through the skin with

one stroke of evenly applied

pressure on the scalpel. Sharp

dissection should be used to cut

through remaining tissues. The

surgeon must preserve the

integrity of as many of the

underlying nerves, blood vessels,

and muscles as possible.

TISSUE HANDLING —

Keeping tissue trauma to a

minimum promotes faster

healing. Throughout the

operative procedure, the surgeon

must handle all tissues very

gently and as little as possible.

Retractors should be placed with

care to avoid excessive pressure,

since tension can cause serious

complications: impaired blood

and lymph flow, altering of the

local physiological state of the

wound, and predisposition to

microbial colonization.

HEMOSTASIS — Various

mechanical, thermal, and

chemical methods are available to

decrease the flow of blood and

fluid into the wound site.

Hemostasis allows the surgeon to

work in as clear a field as possible

with greater accuracy. Without

adequate control, bleeding from

transected or penetrated vessels

or diffused oozing on large

denuded surfaces may interfere

with the surgeon's view of

underlying structures.

Achieving complete hemostasis

before wound closure also will

prevent formation of postopera-

tive hematomas. Collections of

blood (hematomas) or fluid

(seromas) in the incision can

prevent the direct apposition of

tissue needed for complete union

of wound edges. Furthermore,

these collections provide an ideal

culture medium for microbial

growth and can lead to serious

infection.

When clamping or ligating a

vessel or tissue, care must be

taken to avoid excessive tissue

damage. Mass ligation that

involves large areas of tissue may

produce necrosis, or tissue death,

and prolong healing time.

MAINTAINING MOISTURE

IN TISSUES — During long

procedures, the surgeon may

periodically irrigate the wound

with warm physiologic (normal)

saline solution, or cover exposed

surfaces with saline-moistened

sponges or laparotomy tapes to

prevent tissues from drying out.

REMOVAL OF NECROTIC

TISSUE AND FOREIGN

MATERIALS — Adequate

debridement of all devitalized

tissue and removal of inflicted

foreign materials are essential

to healing, especially in traumatic

wounds. The presence of

fragments of dirt, metal, glass,

etc., increases the probability

of infection.

CHOICE OF CLOSURE

MATERIALS — The surgeon

must evaluate each case individu-

ally, and choose closure material

which will maximize the

opportunity for healing and

minimize the likelihood of

WOUND HEALING

✦

infection. The proper closure

material will allow the surgeon

to approximate tissue with as

little trauma as possible, and with

enough precision to eliminate

dead space. The surgeon's

personal preference will play a

large role in the choice of closure

material; but the location of the

wound, the arrangement of tissue

fibers, and patient factors influ-

ence his or her decision as well.

CELLULAR RESPONSE TO

CLOSURE MATERIALS —

Whenever foreign materials such

as sutures are implanted in tissue,

the tissue reacts. This reaction

will range from minimal to

moderate, depending upon the

type of material implanted. The

reaction will be more marked if

complicated by infection, allergy,

or trauma.

Initially, the tissue will deflect the

passage of the surgeon's needle

and suture. Once the sutures

have been implanted, edema of

the skin and subcutaneous tissues

will ensue. This can cause

significant patient discomfort

during recovery, as well as

scarring secondary to ischemic

necrosis. The surgeon must take

these factors into consideration

when placing tension upon the

closure material.

ELIMINATION OF DEAD

SPACE IN THE WOUND —

Dead space in a wound results

from separation of portions of

the wound beneath the skin

edges which have not been

closely approximated, or from air

or fluid trapped between layers of

tissue. This is especially true in

the fatty layer which tends to

lack blood supply. Serum or

blood may collect, providing an

ideal medium for the growth

of microorganisms that cause

infection. The surgeon may

elect to insert a drain or apply

a pressure dressing to help

eliminate dead space in the

wound postoperatively.

CLOSING TENSION —

While enough tension must be

applied to approximate tissue and

eliminate dead space, the sutures

must be loose enough to prevent

exaggerated patient discomfort,

ischemia, and tissue necrosis

during healing.

POSTOPERATIVE

DISTRACTION FORCES —

The patient's postoperative

activity can place undue stress

upon a healing incision.

Abdominal fascia will be placed

under excessive tension after

surgery if the patient strains to

cough, vomit, void, or defecate.

Tendons and the extremities may

also be subjected to excessive

tension during healing. The

surgeon must be certain that

the approximated wound is

adequately immobilized to

prevent suture disruption

for a sufficient period of time

after surgery.

IMMOBILIZATION —

Adequate immobilization of the

approximated wound, but not

necessarily of the entire anatomic

part, is mandatory after surgery

for efficient healing and minimal

scar formation.

CLASSIFICATION

OF WOUNDS

The Centers for Disease Control

and Prevention (CDC), using an

adaptation of the American College

of Surgeons’ wound classification

schema, divides surgical wounds

into four classes: clean wounds,

clean-contaminated wounds,

CHAPTER 1 5

✦

DEAD SPACE

IN A WOUND

✦

FIGURE

* Trademark

contaminated wounds and dirty or

infected wounds.5A discussion of

each follows.

Seventy-five percent of all wounds

(which are usually elective surgical

incisions) fall into the clean wounds

category—an uninfected operative

wound in which no inflammation

is encountered and the respiratory,

alimentary, genital, or uninfected

urinary tracts are not entered.

These elective incisions are made

under aseptic conditions and are

not predisposed to infection.

Inflammation is a natural part of

the healing process and should be

differentiated from infection in

which bacteria are present and

produce damage.

Clean wounds are closed by primary

union and usually are not drained.

Primary union is the most desirable

method of closure, involving the

simplest surgical procedures and

the lowest risk of postoperative

complications. Apposition of tissue

is maintained until wound tensile

strength is sufficient so that sutures

or other forms of tissue apposition

are no longer needed.

Clean-contaminated wounds are

operative wounds in which the

respiratory, alimentary, genital, or

urinary tracts are entered under

controlled conditions and without

unusual contamination. Specifically,

operations involving the biliary

tract, appendix, vagina, and

oropharynx are included in this

category provided no evidence

of infection or major break in

technique is encountered.

Appendectomies, cholecystectomies,

and hysterectomies fall into this

category, as well as normally

clean wounds which become

contaminated by entry into a

viscus resulting in minimal spillage

of contents.

Contaminated wounds include

open, traumatic wounds or injuries

such as soft tissue lacerations, open

fractures, and penetrating wounds;

operative procedures in which gross

spillage from the gastrointestinal

tract occurs; genitourinary or biliary

tract procedures in the presence

of infected urine or bile; and

operations in which a major break

in aseptic technique has occurred

(as in emergency open cardiac

massage). Microorganisms

multiply so rapidly that within

6 hours a contaminated wound

can become infected.

Dirty and infected wounds have

been heavily contaminated or

clinically infected prior to the

operation. They include perforated

viscera, abscesses, or neglected

traumatic wounds in which

devitalized tissue or foreign material

have been retained. Infection

present at the time of surgery can

increase the infection rate of any

wound by an average of four times.

TYPES OF

WOUND HEALING

The rate and pattern of healing falls

into three categories, depending

upon the type of tissue involved

and the circumstances surrounding

closure. Timeframes are generalized

for well-perfused healthy soft

tissues, but may vary.

HEALING BY

PRIMARY INTENTION

Every surgeon who closes a wound

would like it to heal by primary

union or first intention, with

minimal edema and no local

infection or serious discharge. An

incision that heals by primary

intention does so in a minimum of

time, with no separation of the

wound edges, and with minimal

scar formation. This takes place in

three distinct phases:2,3

Inflammatory (preparative) –

During the first few days, an

inflammatory response causes an

outpouring of tissue fluids, an

accumulation of cells and

fibroblasts, and an increased blood

supply to the wound. Leukocytes

and other cells produce proteolytic

enzymes which dissolve and remove

damaged tissue debris. These are

the responses which prepare the site

of injury for repair. The process

lasts 3 to 7 days. Any factor which

interferes with the progress, may

interrupt or delay healing. During

the acute inflammatory phase, the

tissue does not gain appreciable

tensile strength, but depends solely

upon the closure material to hold it

in approximation.

Proliferative – After the

debridement process is well along,

fibroblasts begin to form a collagen

matrix in the wound known as

granulation tissue. Collagen, a

protein substance, is the chief

constituent of connective tissue.

Collagen fiber formation determines

the tensile strength and pliability of

the healing wound. As it fills with

new blood vessels, the granulation

becomes bright, beefy, red tissue.

The thick capillary bed which fills

WOUND HEALING

the matrix, supplies the nutrients

and oxygen necessary for the wound

to heal. This phase occurs from

day 3 onward.

In time, sufficient collagen is laid

down across the wound so that it

can withstand normal stress. The

length of this phase varies with the

type of tissue involved and the

stresses or tension placed upon the

wound during this period.

Wound contraction also occurs dur-

ing this phase. Wound contraction

is a process that pulls the wound

edges together for the purpose of

closing the wound. In essence, it

reduces the open area, and if

successful, will result in a smaller

wound with less need for repair by

scar formation. Wound contraction

can be very beneficial in the closure

of wounds in areas such as the but-

tocks or trochanter but can be very

harmful in areas such as the hand

or around the neck and face, where

it can cause disfigurement and

excessive scarring.3

Surgical wounds that are closed

by primary intention have minimal

contraction response. Skin grafting

is used to reduce avoided contrac-

tion in undesirable locations.

Remodelling – As collagen deposi-

tion is completed, the vascularity of

the wound gradually decreases and

any surface scar becomes paler. The

amount of collagen that is finally

formed – the ultimate scar – is

dependent upon the initial volume

of granulation tissue.2

HEALING BY

SECOND INTENTION

When the wound fails to heal by

primary union, a more complicated

and prolonged healing process takes

place. Healing by second intention

is caused by infection, excessive

trauma, tissue loss, or imprecise

approximation of tissue.3

In this case, the wound may be left

open and allowed to heal from the

inner layer to the outer surface.

Granulation tissue forms and

contains myofibroblasts. These

specialized cells help to close the

wound by contraction. This

process is much slower than primary

intention healing. Excessive

granulation tissue may build up

and require treatment if it protrudes

above the surface of the wound,

preventing epithelialization.

DELAYED PRIMARY

CLOSURE

This is considered by many

surgeons to be a safe method of

management of contaminated, as

well as dirty and infected traumatic

wounds with extensive tissue loss

and a high risk of infection. This

method has been used extensively in

the military arena and has proven

successful following excessive

trauma related to motor vehicle

accidents, shooting incidents, or

infliction of deep, penetrating

knife wounds.3

The surgeon usually treats these

injuries by debridement of

nonviable tissues and leaves the

wound open, inserting gauze

packing which is changed twice a

day. Patients sedation or a return to

the operating room with general

anesthesia generally is only required

in the case of large, complex

wounds. Wound approximation

using adhesive strips, previously

placed but untied sutures, staples

after achieving local anesthesia can

occur within 3-5 days if the wound

demonstrates no evidence of

infection and the appearance of red

granulation tissue. Should this not

CHAPTER 1 7

* Trademark

PHASES OF

WOUND

HEALING

FIGURE

Damaged

tissue

debris Tissue fluids

Fibroblasts Proteolytic

enzymes

Increased blood supply Collagen fibers

PHASE 1–

Inflammatory response and

debridement process

PHASE 2–

Collagen formation

(scar tissue)

PHASE 3–

Sufficient collagen laid down

occur, the wound is allowed to

heal by secondary intention. When

closure is undertaken, skin edges

and underlying tissue must be accu-

rately and securely approximated.

IN THE

NEXT SECTION

The materials, devices, and

techniques used to repair wounded

tissue will be discussed at length.

As you will see, the number of

options available is extensive. But

no matter how many choices the

surgeon has, his or her objective

remains singular: to restore the

patient to health with as little

operative trauma as possible and

an excellent cosmetic result.

REFERENCES

1. Stedman’s Medical Dictionary,

27th edition, 2000

2. Henry, Michael and Thompson,

Jeremy: Clinical Surgery, W.B.

Saunders, 2001

3. Skerris, David A.: Mayo Clinic

Basic Surgery Skills, Mayo Clinic

Scientific Press, 1999

4. Sussman, Carrie: Wound Care,

Aspen Publishers, 1998

5. NNIS Manual, CDC,

MHA, 2000

WOUND HEALING

THE SUTURE

CHAPTER 2

WHAT IS

A SUTURE?

The word "suture" describes any

strand of material used to ligate (tie)

blood vessels or approximate (bring

close together) tissues. Sutures are

used to close wounds. Sutures and

ligatures were used by both the

Egyptians and Syrians as far back as

2,000 B.C. Through the centuries, a

wide variety of materials—silk,

linen, cotton, horsehair, animal

tendons and intestines, and wire

made of precious metals—have been

used in operative procedures. Some

of these are still in use today.

The evolution of suturing material

has brought us to a point of refine-

ment that includes sutures designed

for specific surgical procedures.

Despite the sophistication of

today's suture materials and surgical

techniques, closing a wound still

involves the same basic procedure

used by physicians to the Roman

emperors. The surgeon still uses a

surgical needle to penetrate tissue

and advance a suture strand to its

desired location.

Successful use of suture materials

depends upon the cooperation of

the suture manufacturer and the

surgical team.

The manufacturer must have a

thorough knowledge of surgical

procedures, anticipate the surgical

team's needs, and produce suture

materials that meet these

stringent criteria:

• They must have the greatest

tensile strength consistent with

size limitations.

• They must be easy to handle.

• They must be secured in

packaging which presents them

sterile for use, in excellent

condition, and ensures the

safety of each member of the

surgical team.

The nurse must maintain the

sterility of sutures when storing,

handling, and preparing them for

use. The integrity and strength of

each strand must remain intact

until it is in the surgeon's hands.

The surgeon must select suture

materials appropriate for the

procedure and must place them

in the tissues in a manner consistent

with the principles that promote

wound healing.

With the manufacturer and

surgical team working in concert,

the patient reaps the final

benefit...the wound is closed in a

manner that promotes optimum

healing in minimum time.

PERSONAL SUTURE

PREFERENCE

Most surgeons have a basic

"suture routine," a preference for

using the same material(s) unless

circumstances dictate otherwise.

The surgeon acquires skill,

proficiency, and speed in handling

by using one suture material

repeatedly—and may choose

the same material throughout his

or her entire career.

A number of factors may influence

the surgeon’s choice of materials:

• His or her area of specialization.

• Wound closure experience during

clinical training.

• Professional experience in the

operating room.

• Knowledge of the healing

characteristics of tissues and

organs.

• Knowledge of the physical and

biological characteristics of

various suture materials.

• Patient factors (age, weight,

overall health status, and the

presence of infection).

Surgical specialty plays a

primary role in determining

suture preference. For example,

obstetrician/gynecologists frequently

prefer coated VICRYL* RAPIDE

(polyglactin 910) suture for

episiotomy repair and coated

VICRYL* (polyglactin 910)

suture and MONOCRYL*

(poliglecaprone 25) suture for all

tissue layers except, possibly, skin.

Most orthopaedic surgeons use

coated VICRYL suture, PDS* II

(polydioxanone) suture, and

ETHIBOND* EXCEL polyester

suture. Many plastic surgeons

prefer ETHILON* nylon suture,

VICRYL* suture, or MONOCRYL

suture. Many neurosurgeons

prefer coated VICRYL suture or

NUROLON* braided nylon suture.

But no single suture material is used

by every surgeon who practices within

a specialty.

The surgeon's knowledge of the

physical characteristics of suture

material is important. As the

requirements for wound support

vary with patient factors, the nature

THE SUTURE

of the procedure, and the type of

tissue involved, the surgeon will

select suture material that will retain

its strength until the wound heals

sufficiently to withstand stress on

its own.

SUTURE

CHARACTERISTICS

The choice of suture materials gen-

erally depends on whether the

wound closure occurs in one or

more layers. In selecting the most

appropriate sutures, the surgeon

takes into account the amount of

tension on the wound, the number

of layers of closure, depth of suture

placement, anticipated amount of

edema, and anticipated timing of

suture removal.

Optimal suture qualities include:

1. High uniform tensile strength,

permitting use of finer sizes.

2. High tensile strength retention

in vivo, holding the wound

securely throughout the critical

healing period, followed by

rapid absorption.

3. Consistent uniform diameter.

4. Sterile.

5. Pliable for ease of handling and

knot security.

6. Freedom from irritating

substances or impurities for

optimum tissue acceptance.

7. Predictable performance.

SIZE AND TENSILE

STRENGTH

Size denotes the diameter of the

suture material. The accepted

surgical practice is to use the

smallest diameter suture that

will adequately hold the mending

wounded tissue. This practice

minimizes trauma as the suture is

passed through the tissue to effect

closure. It also ensures that the

minimum mass of foreign material

is left in the body. Suture size is

stated numerically; as the number of

0s in the suture size increases, the

diameter of the strand decreases. For

example, size 5-0, or 00000, is

smaller in diameter than size 4-0, or

0000. The smaller the size, the less

tensile strength the suture will have.

Knot tensile strength is measured by

the force, in pounds, which the

suture strand can withstand before

it breaks when knotted. The tensile

strength of the tissue to be mended

(its ability to withstand stress)

determines the size and tensile

strength of the suturing material the

surgeon selects. The accepted rule is

that the tensile strength of the

suture need never exceed the tensile

strength of the tissue. However,

sutures should be at least as strong

as normal tissue through which they

are being placed.

MONOFILAMENT VS.

MULTIFILAMENT STRANDS

Sutures are classified according to

the number of strands of which

they are comprised. Monofilament

sutures are made of a single strand

of material. Because of their

simplified structure, they encounter

less resistance as they pass

through tissue than multifilament

suture material. They also resist

harboring organisms which may

cause infection.

These characteristics make

monofilament sutures well-suited

to vascular surgery. Monofilament

sutures tie down easily. However,

because of their construction,

extreme care must be taken when

handling and tying these sutures.

Crushing or crimping of this suture

type can nick or create a weak spot

in the strand. This may result in

suture breakage.

Multifilament sutures consist of

several filaments, or strands, twisted

or braided together. This affords

greater tensile strength, pliability, and

flexibility. Multifilament sutures may

also be coated to help them pass rela-

tively smoothly through tissue and

enhance handling characteristics.

Coated multifilament sutures are

well-suited to intestinal procedures.

CHAPTER 2 11

METRIC MEASURES AND U.S.P.

SUTURE DIAMETER EQUIVALENTS TABLE

U.S.P. Size

Natural

Collagen

Synthetic

Absorbables

Nonabsorbable

Materials

11-0

–––

0.1

10-0

0.2

9-0

0.3

8-0

0.5

0.4

7-0

0.7

0.5

6-0

1.0

0.7

5-0

1.5

1.0

4-0

2.0

1.5

3-0

3.0

2.0

2-0

3.5

3.0

4.0

3.5

5.0

4.0

6.0

5.0

7.0

6.0

8.0

6.0

–––

7.0

–––

8.0

* Trademark

ABSORBABLE VS.

NONABSORBABLE SUTURES

Sutures are classified according to

their degradation properties.

Sutures that undergo rapid degrada-

tion in tissues, losing their tensile

strength within 60 days, are

considered absorbable sutures.

Sutures that generally maintain

their tensile strength for longer than

60 days are nonabsorbable sutures.

Absorbable sutures may be used to

hold wound edges in approximation

temporarily, until they have healed

sufficiently to withstand normal

stress. These sutures are prepared

either from the collagen of healthy

mammals or from synthetic

polymers. Some are absorbed

rapidly, while others are treated or

chemically structured to lengthen

absorption time. They may also be

impregnated or coated with agents

that improve their handling

properties, and colored with an

FDA-approved dye to increase

visibility in tissue. Natural

absorbable sutures are digested by

body enzymes which attack and

break down the suture strand.

Synthetic absorbable sutures are

hydrolyzed—a process by which

water gradually penetrates the

suture filaments, causing the

breakdown of the suture's polymer

chain. Compared to the enzymatic

action of natural absorbables,

hydrolyzation results in a lesser

degree of tissue reaction following

implantation.

During the first stage of the

absorption process, tensile strength

diminishes in a gradual, almost

linear fashion. This occurs over the

first several weeks postimplantation.

The second stage often follows with

considerable overlap, characterized

by loss of suture mass. Both stages

exhibit leukocytic cellular responses

which serve to remove cellular

debris and suture material from the

line of tissue approximation.

The loss of tensile strength and

the rate of absorption are separate

phenomena. A suture can lose

tensile strength rapidly and yet be

absorbed slowly—or it can

maintain adequate tensile strength

through wound healing, followed

by rapid absorption. In any case,

the strand is eventually completely

dissolved, leaving no detectable

traces in tissue.

Although they offer many

advantages, absorbable sutures also

have certain inherent limitations.

If a patient has a fever, infection,

or protein deficiency, the suture

absorption process may accelerate,

causing too rapid a decline in tensile

strength. In addition, if the sutures

become wet or moist during

handling, prior to being implanted

in tissue, the absorption process

may begin prematurely. Similarly,

patients with impaired healing

are often not ideal candidates

for this type of suture. All of

these situations predispose to

postoperative complications, as

the suture strand will not maintain

adequate strength to withstand

stress until the tissues have

healed sufficiently.

Nonabsorbable sutures are those

which are not digested by body

enzymes or hydrolyzed in body

tissue. They are made from a variety

of nonbiodegradable materials and

are ultimately encapsulated or

walled off by the body’s fibroblasts.

Nonabsorbable sutures ordinarily

remain where they are buried

THE SUTURE

ABSORBABLE

SUTURES:

BASIC RAW

MATERIALS

Surgical Gut

Plain

Chromic

Fast Absorbing

Polyglactin 910

Uncoated (VICRYL*

(polyglactin 910) Suture)

Coated (coated VICRYL*

(polyglactin 910) suture),

(coated VICRYL* RAPIDE

(polyglactin 910) suture)

Polyglycolic Acid

Poliglecaprone 25

(MONOCRYL*

(poliglecaprone 25) suture)

Polyglyconate

Polydioxanone (PDS* II

(polydioxanone) suture)

TABLE

Submucosa of sheep

intestine or serosa of beef

intestine

Copolymer of glycolide and

lactide with polyglactin 370

and calcium stearate, if coated

Homopolymer of glycolide

Copolymer of glycolide and

epsilon-caprolactone

Copolymer of glycolide and

trimethylene carbonate

Polyester of poly (p-dioxanone)

SUTURE RAW MATERIAL

within the tissues. When used for

skin closure, they must be removed

postoperatively. Nonabsorbable

sutures may be used in a variety

of applications:

• Exterior skin closure, to be

removed after sufficient healing

has occurred.

• Within the body cavity, where

they will remain permanently

encapsulated in tissue.

• Patient history of reaction to

absorbable sutures, keloidal

tendency, or possible tissue

hypertrophy.

• Prosthesis attachment

(i.e., defibrillators, pacemakers,

drug delivery mechanisms).

Nonabsorbable sutures are com-

posed of single or multiple filaments

of metal, synthetic, or organic fibers

rendered into a strand by spinning,

twisting, or braiding. Each strand is

substantially uniform in diameter

throughout its length, conforming

to the United States Pharmacopeia

(U.S.P.) limitations for each size.

Nonabsorbable sutures have been

classified by the U.S.P. according to

their composition. In addition,

these sutures may be uncoated

or coated, uncolored, naturally

colored, or dyed with an FDA-

approved dye to enhance visibility.

SPECIFIC SUTURING

MATERIALS

The materials and products

described here embody the most

current advances in the manufacture

of surgical sutures. They are

grouped as either absorbable or

nonabsorbable for easy reference.

Absorbable Sutures

Surgical Gut

Absorbable surgical gut is classified

as either plain or chromic. Both

types consist of processed strands of

highly purified collagen. The

percentage of collagen in the suture

determines its tensile strength and

its ability to be absorbed by the

body without adverse reaction.

Noncollagenous material can cause

a reaction ranging from irritation to

rejection of the suture. The more

pure collagen throughout the

length of the strand, the less foreign

material there is introduced into

the wound.

ETHICON* surgical gut sutures are

manufactured from between 97%

and 98% pure ribbons of collagen.

To meet U.S.P. specifications,

processed ribbons of the submucosa

layer of sheep intestine or the

serosa layer of beef intestine are

electronically spun and polished

into virtually monofilament strands

of various sizes, with minimum and

maximum limits on diameter for

each size. The ETHICON exclusive

TRU-GAUGING process produces

a uniform diameter to within an

accuracy of 0.0002 inch

(0.0175mm) along the entire

length of every strand, eliminating

high and low spots. High and low

spots can cause the suture to fray

or chatter when knots are tied

down, resulting in a knot that is

not positioned properly or tied

securely. Most protein-based

absorbable sutures have a tendency

to fray when tied.

TRU-GAUGING ensures that

ETHICON surgical gut sutures

possess uniform high tensile

strength, virtually eliminating the

possibility of fray or breaking. Their

unexceeded strength and surface

smoothness allow the surgeon to

"snug down" the suture knot to

achieve optimum tension.

The rate of absorption of surgical

gut is determined by the type of

CHAPTER 2 13

* Trademark

NON-

ABSORBABLE

SUTURES: RAW

MATERIALS

Surgical Silk

Stainless Steel Wire

Nylon (ETHILON* nylon

suture, NUROLON* nylon

suture)

Polyester Fiber

Uncoated (MERSILENE*

polyester fiber suture)

Coated (ETHIBOND* EXCEL

polyester suture

Polypropylene (PROLENE*

polypropylene suture)

Poly(hexafluoropropylene-VDF)

(PRONOVA* poly(hexafluoro-

propylene-VDF) suture)

Raw silk spun by silkworm

Specially formulated

iron-chromium-nickel-

molybdenum alloy

Polyamide polymer

Polymer of polyethylene

terephthalate (may be coated)

Polymer of propylene

Polymer blend of poly(vinylidene

fluoride) and poly(vinylidene fluo-

ride-cohexafluoropropylene)

SUTURE RAW MATERIAL

TABLE

gut being used, the type and

condition of the tissue involved,

and the general health status of the

patient. Surgical gut may be used in

the presence of infection, although

it may be absorbed more rapidly

under this condition.

Plain surgical gut is rapidly

absorbed. Tensile strength is

maintained for only 7 to 10 days

postimplantation, and absorption

is complete within 70 days. The

surgeon may choose plain gut for

use in tissues which heal rapidly

and require minimal support (for

example, ligating superficial blood

vessels and suturing subcutaneous

fatty tissue). Plain surgical gut can

also be specially heat-treated to

accelerate tensile strength loss and

absorption. This fast absorbing

surgical gut is used primarily for

epidermal suturing where sutures

are required for only 5 to 7 days.

These sutures have less tensile

strength than plain surgical gut

of the comparable U.S.P. size. Fast

absorbing plain gut is not to be

used internally.

Chromic gut is treated with a

chromium salt solution to resist

body enzymes, prolonging

absorption time over 90 days.

The exclusive CHROMICIZING

process used by ETHICON

thoroughly bathes the pure collagen

ribbons in a buffered chrome

tanning solution before spinning

into strands. After spinning, the

entire cross section of the strand

is evenly chromicized. The process

alters the coloration of the surgical

gut from yellowish-tan to brown.

Chromic gut sutures minimize

tissue irritation, causing less

reaction than plain surgical gut

during the early stages of wound

healing. Tensile strength may be

retained for 10 to 14 days, with

some measurable strength remaining

for up to 21 days.

SYNTHETIC

ABSORBABLE SUTURES

Synthetic absorbable sutures offer the

strength needed for a wide range of

applications, from abdominal and

chest wound closure to ophthalmic

and plastic surgery.

COATED VICRYL* RAPIDE

(POLYGLACTIN 910) SUTURE

This braided suture is composed of

the same copolymer as coated

VICRYL suture—lactide and

glycolide—and is coated with a

combination of equal parts of

copolymer of lactide and glycolide

(polyglactin 370) and calcium

stearate. However, the absorption

rate and tensile strength profile are

significantly different from coated

VICRYL suture, achieved by the use

of a polymer material with a lower

molecular weight than coated

VICRYL suture. Coated VICRYL

RAPIDE sutures are only available

undyed.

Coated VICRYL RAPIDE suture

is the fastest-absorbing synthetic

suture and exhibits characteristics

that model the performance of

surgical gut suture. However,

being a synthetic material. Coated

VICRYL RAPIDE suture elicits

a lower tissue reaction than chromic

gut suture. Coated VICRYL

RAPIDE suture is indicated only

for use in superficial soft tissue

approximation of the skin and

mucosa, where only short-term

wound support (7 to 10 days)

is required. It is not to be used in

ligation, in ophthalmic, cardiovascu-

lar, or neurological procedures,

where extended approximation of

tissues under stress is required, or

where wound support beyond 7

days is required.

Coated VICRYL RAPIDE sutures

retain approximately 50% of the

original tensile strength at 5 days

postimplantation. All of the original

tensile strength is lost by approxi-

mately 10 to 14 days. Absorption is

essentially complete by 42 days.

Coated VICRYL RAPIDE suture

is particularly well-suited for skin

closure, episiotomy repair, and

closure of lacerations under casts.

In addition, since the suture begins

to "fall off" in 7 to 10 days as the

wound heals, the need for suture

removal is eliminated.

MONOCRYL*

(POLIGLECAPRONE 25) SUTURE

This monofilament suture

features superior pliability for easy

handling and tying. Comprised

of a copolymer of glycolide and

epsilon-caprolactone, it is virtually

inert in tissue and absorbs

predictably. The surgeon may

prefer MONOCRYL sutures for

procedures which require high

initial tensile strength diminishing

over 2 weeks postoperatively. These

include subcuticular closure and

soft tissue approximations and

ligations, with the exception of

neural, cardiovascular, ophthalmic,

and microsurgical applications.

MONOCRYL suture is available

dyed (violet) and undyed (natural).

Dyed MONOCRYL suture retains

60% to 70% of its original strength

at 7 days postimplantation, reduced

to 30% to 40% at 14 days, with all

THE SUTURE

original strength lost by 28 days.

At 7 days, undyed MONOCRYL

suture retains approximately 50%

to 60% of its original strength, and

approximately 20% to 30% at

14 days postimplantation. All of

the original tensile strength of

undyed MONOCRYL suture is

lost by 21 days postimplantation.

Absorption is essentially complete

at 91 to 119 days.

COATED VICRYL*

(POLYGLACTIN 910) SUTURE

This material fills the need for a

smoother synthetic absorbable

suture that will pass through tissue

readily with minimal drag. Coated

VICRYL sutures facilitate ease of

handling, smooth tie down and

unsurpassed knot security.

The coating is a combination of

equal parts of copolymer of lactide

and glycolide (polyglactin 370),

plus calcium stearate which is

used extensively in pharmaceuticals

and food. Calcium stearate is a salt

of calcium and stearic acid, both

of which are present in the body

and constantly metabolized and

excreted. The result of this mixture

is an outstandingly absorbable,

adherent, nonflaking lubricant.

At 2 weeks postimplantation,

approximately 75% of the tensile

strength of coated VICRYL suture

remains. Approximately 50% of

tensile strength is retained at 3

weeks for sizes 6-0 and larger. At 3

weeks, 40% of tensile strength is

retained for sizes 7-0 and smaller. At

4 weeks, 25% of the original

strength is retained for sizes 6-0 and

larger. All of the original tensile

strength is lost by five weeks post

implantation. Absorption of coated

VICRYL suture is essentially

complete between 56 and 70 days.

Lactide and glycolide acids are

readily eliminated from the body,

primarily in urine. As with

uncoated sutures, coated VICRYL

sutures elicit only a mild tissue

reaction during absorption. Their

safety and effectiveness in neural

and cardiovascular tissue have not

been established. Transcutaneous or

conjunctival sutures remaining in

place longer than 7 days may cause

localized irritation and should be

removed as indicated. Coated

VICRYL sutures are available as

braided dyed violet or undyed

natural strands in a variety of

lengths with or without needles.

VICRYL* (POLYGLACTIN 910)

SUTURE

This synthetic absorbable suture is a

copolymer of lactide and glycolide

(from lactic and glycolic acid). Both

are natural metabolic substances.

The water-repelling quality of

lactide slows water penetration into

the suture filaments, thus slowing

the rate of in vivo tensile strength

loss as compared to natural

absorbable sutures which are subject

to enzymatic digestion. Lactides are

also bulky, keeping the submicro-

scopic polymer chains comprising

the filaments spaced apart so that

absorption of the suture mass is

rapid once tensile strength is lost.

The combination of lactide and

glycolide results in a molecular

structure which maintains sufficient

tensile strength for efficient

approximation of tissues during

the critical wound-healing period,

followed by rapid absorption.

VICRYL sutures (size 6-0 and

larger) retain approximately 75%

of original tensile strength 2 weeks

after implantation. At 3 weeks, 50%

of tensile strength is retained. At

4 weeks, 20-30% of tensile strength

is retained.

Because synthetic absorbable sutures

are not digested by enzymatic

activity, they exhibit a lower degree

of tissue reaction than surgical gut.

VICRYL suture is extruded into

monofilament strands which are

dyed violet to enhance visibility in

tissue. They are available for use in

ophthalmic surgery. Conjunctival

sutures remaining in place longer

than 7 days may cause localized

irritation and should be removed

as indicated.

PDS* II (POLYDIOXANONE)

SUTURE

Comprised of the polyester poly

(p-dioxanone), this monofilament

represents a significant advance

in suturing options. It combines

the features of soft, pliable,

monofilament construction with

absorbability and extended wound

support for up to 6 weeks. It elicits

only a slight tissue reaction. This

material is well-suited for many

types of soft tissue approximation,

including pediatric cardiovascular,

orthopaedic, gynecologic,

ophthalmic, plastic, digestive,

and colonic surgeries.

Like other synthetic absorbable

sutures, PDS II sutures are

absorbed in vivo through hydrolysis.

Approximately 70% of tensile

strength remains 2 weeks

postimplantation, 50% at 4 weeks,

and 25% at 6 weeks. Absorption is

minimal until about the 90th day

CHAPTER 2 15

* Trademark

postoperatively and essentially

complete within 6 months. The

safety and effectiveness of PDS II

sutures in microsurgery, neural

tissue, and adult cardiovascular

tissue have not been established.

PDS II sutures are available clear

or dyed violet to enhance visibility.

NONABSORBABLE SUTURES

The U.S.P. classifies nonabsorbable

surgical sutures as follows:

• CLASS I—Silk or synthetic fibers

of monofilament, twisted, or

braided construction.

• CLASS II—Cotton or linen

fibers, or coated natural or

synthetic fibers where the coating

contributes to suture thickness

without adding strength.

• CLASS III—Metal wire of

monofilament or multifilament

construction.

SURGICAL SILK

For many surgeons, surgical silk

represents the standard handling

performance by which newer

synthetic materials are judged,

especially due to its superior

handling characteristics. Silk

filaments can be twisted or braided,

the latter providing the best

handling qualities.

Raw silk is a continuous filament

spun by the silkworm moth larva

to make its cocoon. Cream or

orange-colored in its raw state, each

silk filament is processed to remove

natural waxes and sericin gum,

which is exuded by the silkworm as

it spins its cocoon. The gum holds

the cocoon together, but is of no

benefit to the quality of braided

surgical silk sutures.

ETHICON degums the silk for

most suture sizes before the

braiding process. This allows for a

tighter, more compact braid which

significantly improves suture quality.

After braiding, the strands are dyed,

scoured and stretched, and then

impregnated and coated with a

mixture of waxes or silicone. Each

of these steps is critical to the

quality of the finished suture and

must be carried out in precise order.

Surgical silk is usually dyed black

for easy visibility in tissue.

Raw silk is graded according to

strength, uniformity of filament

diameter, and freedom from defects.

Only top grades of silk filaments are

used to produce PERMA-HAND*

surgical silk sutures.

Surgical silk loses tensile strength

when exposed to moisture and

should be used dry. Although silk

is classified by the U.S.P. as a

nonabsorbable suture, long-term

in vivo studies have shown that it

loses most or all of its tensile

strength in about 1 year and usually

cannot be detected in tissue after

2 years. Thus, it behaves in reality

as a very slowly absorbing suture.

SURGICAL STAINLESS STEEL

The essential qualities of surgical

stainless steel sutures include the

absence of toxic elements, flexibility,

and fine wire size. Both monofila-

ment and twisted multifilament

varieties are high in tensile strength,

low in tissue reactivity, and hold

a knot well. Provided that the

sutures do not fragment, there is

little loss of tensile strength in

tissues. The 316L (low carbon)

stainless steel alloy formula used

in the manufacture of these

sutures offers optimum metal

strength, flexibility, uniformity,

and compatibility with stainless

steel implants and prostheses.

Stainless steel sutures may also be

used in abdominal wall closure,

sternum closure, retention, skin

closure, a variety of orthopaedic

procedures, and neurosurgery.

Disadvantages associated with

alloy sutures include difficulty in

handling; possible cutting, pulling,

and tearing of the patient's tissue;

fragmentation; barbing; and

kinking, which renders the stainless

steel suture useless. When used for

bone approximation and fixation,

asymmetrical twisting of the wire

will lead to potential buckling, wire

fracture, or subsequent wire

fatigue. Incomplete wire fixation

under these circumstances will

permit movement of the wire,

resulting in postoperative pain

and possible dehiscence.

Surgical stainless steel sutures

should not be used when a

prosthesis of another alloy is

implanted since an unfavorable

electrolytic reaction may occur.

Above all, stainless steel sutures

pose a safety risk. They easily tear

surgical gloves when handled

and may puncture the surgeon's

own skin—putting both

physician and patient at risk

of transmitted immunodeficiency

virus or hepatitis. Many surgeons

refer to wire size by the Brown &

Sharpe (B & S) gauge of 40

(smallest diameter) to 18 (largest

diameter). ETHICON labels

surgical stainless steel with both

the B & S and U.S.P. diameter size

classifications.

THE SUTURE

ETHICON packaging of surgical

stainless steel maintains the integrity

of the product by eliminating kink-

ing and bending of strands. Just as

important, it presents the strands in

a safe manner for all members of

the surgical team who handle them.

SYNTHETIC

NONABSORBABLE SUTURES

Nylon sutures are a polyamide poly-

mer derived by chemical synthesis.

Because of their elasticity, they are

particularly well-suited for retention

and skin closure. They may be

clear, or dyed green or black for

better visibility.

ETHILON* NYLON SUTURE

These sutures are extruded into

noncapillary single or monofilament

strands characterized by high tensile

strength and extremely low tissue

reactivity. They degrade in vivo at a

rate of approximately 15% to 20%

per year by hydrolysis. ETHILON

sutures in sizes 10-0 and 6-0 and

larger are produced from a special

grade of nylon 6. The medical grade

polyamide nylon 6-6 is used for

sizes 7-0 and finer. While both

grades permit good handling,

monofilament nylon sutures have a

tendency to return to their original

straight extruded state (a property

known as "memory"). Therefore,

more throws in the knot are

required to securely hold monofila-

ment than braided nylon sutures.

Monofilament nylon in a wet or

damp state is more pliable and

easier to handle than dry nylon. A

limited line of ETHILON sutures

(sizes 3-0 through 6-0) are pre-

moistened or "pliabilized" for use

in cosmetic plastic surgery. This

process enhances the handling

and knot tying characteristics to

approximate that of braided sutures.

ETHILON sutures are frequently

used in ophthalmology and

micro-surgery procedures in very

fine sizes. For this reason, sizes 9-0

and 10-0 have an intensified black

dye for high visibility.

NUROLON* NYLON SUTURE

This suture is composed of

filaments of nylon that have been

tightly braided into a multifilament

strand. Available in white or dyed

black, NUROLON sutures look,

feel, and handle like silk. However,

NUROLON sutures have more

strength and elicit less tissue

reaction than silk. Braided nylon

may be used in all tissues where

multifilament nonabsorbable sutures

are acceptable. Braided nylon

sutures generally lose 15% to 20%

of their tensile strength per year in

tissue by hydrolyzation.

Polyester fiber suture is comprised

of untreated fibers of polyester

(polyethylene terephthalate) closely

braided into a multifilament strand.

They are stronger than natural

fibers, do not weaken when wetted

prior to use, and cause minimal

tissue reaction. Available white or

dyed green, polyester fiber sutures

are among the most acceptable for

vascular synthetic prostheses.

MERSILENE* POLYESTER

FIBER SUTURE

The first synthetic braided suture

material shown to last indefinitely

in the body, MERSILENE sutures

provide precise, consistent suture

tension. They minimize breakage

and virtually eliminate the need to

remove irritating suture fragments

postoperatively. Because it is

uncoated, MERSILENE suture

has a higher coefficient of friction

when passed through tissue.

CHAPTER 2 17

* Trademark

SURGICAL

STAINLESS

STEEL: WIRE

GAUGE

EQUIVALENTS

DIAMETER U.S.P. B & S

.0031 inch

.0040

.0056

.0063

.0080

.0100

.0126

.0159

.0179

.0201

.0226

.0253

.0320

.0360

.0400

6-0

5-0

4-0

3-0

2-0

TABLE

ETHIBOND* EXCEL

POLYESTER SUTURE

ETHIBOND EXCEL sutures are

uniformly coated with polybutilate,

a biologically inert, nonabsorbable

compound which adheres itself to

the braided polyester fiber strand.

Polybutilate was the first synthetic

coating developed specifically as a

surgical suture lubricant. The coat-

ing eases the passage of the braided

strands through tissue and provides

excellent pliability, handling quali-

ties, and smooth tie-down with each

throw of the knot. Both the suture

material and the coating are

pharmacologically inactive. The

sutures elicit minimal tissue reaction

and retain their strength in vivo for

extended periods. ETHIBOND*

EXCEL sutures are used primarily in

cardiovascular surgery, for vessel

anastomosis, and placement of

prosthetic materials.

ETHIBOND EXCEL sutures

are also available attached

to TFE polymer felt pledgets.

Pledgets serve to prevent possible

tearing of adjacent friable tissue.

Pledgets are used routinely in valve

replacement procedures (to prevent

the annulus from tearing when the

prosthetic valve is seated and the

sutures are tied), and in situations

where extreme deformity, distortion,

or tissue destruction at the annulus

has occurred.

Polypropylene is an isostatic

crystalline stereoisomer of a

linear hydrocarbon polymer

permitting little or no saturation.

Manufactured by a patented

process which enhances pliability

and handling, polypropylene

monofilament sutures are not

subject to degradation or weakening

by tissue enzymes. They cause

minimal tissue reaction and hold

knots better than most other

synthetic monofilament materials.

PROLENE* POLYPROPYLENE

SUTURE

Widely used in general, cardiovascu-

lar, plastic, and orthopaedic surgery,

PROLENE sutures do not adhere to

tissue and are therefore efficacious

as a pull-out suture. PROLENE

sutures are relatively biologically

inert, offering proven strength,

reliability and versatility.

PROLENE sutures are

recommended for use where

minimal suture reaction is desired,

such as in contaminated and

infected wounds to minimize

later sinus formation and suture

extrusion. They are available clear

or dyed blue.

PRONOVA* POLY

(HEXAFLUOROPROPYLENE-VDF)

SUTURE

This monofilament nonabsorbable

suture is a polymer blend of poly

(vinylidene fluoride) and poly

(vinylidene fluoride-cohexafluoro-

propylene). This suture resists

involvement in infection and has

been successfully employed in

contaminated and infected wounds

to eliminate or minimize later sinus

formation and suture extrusion.

Furthermore, the lack of adherence

to tissues has facilitated the use

of PRONOVA suture as a

pull-out suture.

This material is well-suited for

many types of soft tissue approxi-

mation and ligation, including use

in cardiovascular, ophthalmic and

neurological procedures.

Table 5 gives an overview of the

many suturing options that have

been discussed in this section.

(See attached chart )

COMMON

SUTURING

TECHNIQUES

LIGATURES

A suture tied around a vessel to

occlude the lumen is called a

ligature or tie. It may be used to

effect hemostasis or to close off a

structure to prevent leakage.

There are two primary types

of ligatures.

Free tie or freehand ligatures are

single strands of suture material

used to ligate a vessel, duct, or other

structure. After a hemostat or other

similar type of surgical clamp has

been placed on the end of the

structure, the suture strand is tied

around the vessel under the tip of

the hemostat. The hemostat is

removed after the first throw and

the surgeon tightens the knot using

his or her fingertips, taking care to

avoid instrument damage to the

suture. Additional throws are added

as needed to square and secure the

knot. Stick tie, suture ligature, or

transfixion suture is a strand of

suture material attached to a needle

to ligate a vessel, duct, or other

structure. This technique is used on

deep structures where placement of

a hemostat is difficult or on vessels

of large diameter. The needle is

passed through the structure or

adjacent tissue first to anchor the

suture, then tied around the

structure. Additional throws are

used as needed to secure the knot.

THE SUTURE

* Trademark

THE PRIMARY SUTURE LINE

The primary suture line is the line

of sutures that holds the wound

edges in approximation during

healing by first intention. It may

consist of a continuous strand of

material or a series of interrupted

suture strands. Other types of

primary sutures, such as deep

sutures, buried sutures, purse-string

sutures, and subcuticular sutures,

are used for specific indications.

Regardless of technique, a surgical

needle is attached to the suture

strand to permit repeated passes

through tissue.

CONTINUOUS SUTURES

Also referred to as running stitches,

continuous sutures are a series of

stitches taken with one strand of

material. The strand may be tied to

itself at each end, or looped, with

both cut ends of the strand tied

together. A continuous suture line

can be placed rapidly. It derives its

strength from tension distributed

evenly along the full length of the

suture strand. However, care must

be taken to apply firm tension,

rather than tight tension, to avoid

tissue strangulation. Excessive

tension and instrument damage

should be avoided to prevent suture

breakage which could disrupt the

entire line of a continuous suture.

Continuous suturing leaves less

foreign body mass in the wound.

In the presence of infection, it may

be desirable to use a monofilament

suture material because it has no

interstices which can harbor

microorganisms. This is especially

critical as a continuous suture

line can transmit infection along

the entire length of the strand. A

continuous one layer mass closure

CHAPTER 2 19

LIGATURES

CONTINUOUS

SUTURING

TECHNIQUES

FIGURE

Free tie Stick tie

Looped suture, knotted

at one end

Two strands knotted at

each end and knotted in

the middle

Running locked suture Over-and-over running

stitch

FIGURE

INTERRUPTED

SUTURING

TECHNIQUES

Simple interrupted

Interrupted vertical

mattress

Interrupted horizontal

mattress

TYPES

Plain

Chromic

Braided

Monofilament

Braided

Monofilament

Braided

Monofilament

Mulifilament

Monofilament

Braided

Monofilament

Braided

Monofilament

ABSORBABLE SUTURES

SUTURE

Surgical Gut

Suture

Surgical Gut

Suture

Coated

VICRYL* RAPIDE

(polyglactin 910)

Suture

MONOCRYL*

(poliglecaprone 25)

Suture

Coated VICRYL*

(polyglactin 910)

Suture

PDS* II

(polydioxanone)

Suture

PERMA-HAND*

Silk Suture

Surgical Stainless

Steel Suture

ETHILON*

Nylon Suture

NUROLON*

Nylon Suture

MERSILENE*

Polyester Fiber

Suture

ETHIBOND*

EXCEL Polyester

Fiber Suture

PROLENE*

Polypropylene

Suture

PRONOVA*

POLY (hexafluoro-

propylene-VDF)

Suture

COLOR OF

MATERIAL

Yellowish-tan

Blue Dyed

Brown

Blue Dyed

Undyed

(Natural)

Undyed

(Natural)

Violet

Undyed

(Natural)

Violet

Blue

Clear

Violet

White

Silver metallic

Violet

Green

Undyed (Clear)

Violet

Green

Undyed (Clear)

Green

Undyed (White)

Green

Undyed (White)

Clear

Blue

RAW MATERIAL

Collagen derived from

healthy beef and sheep.

Collagen derived from

healthy beef and sheep.

Copolymer of lactide

and glycolide coated

with 370 and calcium

stearate.

Copolymer of

glycolide and

epsilon-caprolactone.

Copolymer of lactide

and glycolide coated

with 370 and calcium

stearate.

Polyester polymer.

Organic protein called

fibrin.

316L stainless steel.

Long-chain aliphatic

polymers Nylon 6 or

Nylon 6,6.

Long-chain aliphatic

polymers Nylon 6 or

Nylon 6,6.

Poly (ethylene

terephthalate).

Poly (ethylene

terephthalate) coated

with polybutilate.

Isotactic crystalline

stereoisomer of

polypropylene.

Polymer blend of poly

(vinylidene fluoride)

and poly (vinylidene

fluoride-cohexafluoro-

propylene).

TENSILE STRENGTH

RETENTION in vivo

Individual patirent characteristics can

affect rate of tensile strength loss.

Individual patirent characteristics can

affect rate of tensile strength loss.

Approximately 50% remains at 5

days. All tensile strength is lost at

approximately 14 days.

Approximately 50-60% (violet: 60-70%)

remains at 1 week. Approximately 20-

30% (violet: 30-40%) remains at 2 weeks.

Lost within 3 weeks (violet: 4 weeks).

Approximately 75% remains at two

weeks. Approximately 50% remains

at three weeks, 25% at four weeks.

Approximately 70% remains at 2 weeks.

Approximately 50% remains at 4 weeks.

Approximately 25% remains at 6 weeks.

Progressive degradation of fiber may

result in gradual loss of tensile

strength over time.

Indefinate.

Progressive hydrolysis may result in

gradual loss of tensile strength over

time.

Progressive hydrolysis may result in

gradual loss of tensile strength over

time.

No significant change known to

occur in vivo.

No significant change known to

occur in vivo.

No subject to degradation or

weakening by action of tissue

enzymes.

No subject to degradation or

weakening by action of tissue

enzymes.

ABSORPTION RATE

Absorbed by proleolytic

enzymatic digestive

process.

Absorbed by proleolytic

enzymatic digestive

process.

Essentially complete

between 42 days.

Absorbed by hydrolysis.

Complete at 91-119

days. Absorbed by

hydrolysis.

Essentially complete

between 56-70 days.

Absorbed by hydrolysis.

Minimal until about 90th

day. Essentially complete

within 6 months. Absorbed

by slow hydrolysis.

Gradual encapsulation

by fibrous connective

tissue.

Nonabsorbable.

Gradual encapsulation

by fibrous connective

tissue.

Gradual encapsulation

by fibrous connective

tissue.

Gradual encapsulation

by fibrous connective

tissue.

Gradual encapsulation

by fibrous connective

tissue.

Nonabsorbable.

TISSUE REACTION

Moderate reaction

Minimal to moderate

acute inflammatory

reaction

Minimal acute

inflammatory reaction

Minimal acute

inflammatory reaction

Slight reaction

Acute inflammatory

reaction

Minimal acute

inflammatory reaction

Minimal acute

inflammatory reaction

Minimal acute

inflammatory reaction

Minimal acute

inflammatory reaction

Minimal acute

inflammatory reaction

Minimal acute

inflammatory reaction

Minimal acute

inflammatory reaction

NONABSORBABLE SUTURES

SUTURING

OPTIONS:

MATERIALS,

CHARACTERISTICS,

AND APPLICATIONS

CONTRAINDICATIONS

Being absorbable, should not be used

where extended approximation of tissues

under stress is required. Should not be

used in patients with known sensitivities

or allergies to collagen or chromium.

Being absorbable, should not be used

where extended approximation of tissues

under stress is required. Should not be

used in patients with known sensitivities

or allergies to collagen or chromium.

Should not be used where extended

approximation of tissue under stress is

required or where wound support beyond

7 days is required.

Being absorbable, should not be used

where extended approximation of tissue

under stress is required. Undyed not

indicated for use in fascia.

Being absorbable, should not be used

where extended approximation of tissue

is required.

Being absorbable, should not be used where

prolonged approximation of tissues under

stress is required. Should not be used with

prosthetic devices, such as heart valves or

synthetic grafts.

Should not be used in patients with

known sensitivities or allergies to silk.

Should not be used in patients with

known sensitivities or allergies to 316L

stainless steel, or constituent metals such

as chromium and nickel.

Should not be used where permanent

retention of tensile strength is required.

Should not be used where permanent

retention of tensile strength is required.

None known.

FREQUENT USES

General soft tissue approximation

and/or ligation, including use in

ophthalmic procedures. Not for use

in cardiovascular and neurological

tissues.

General soft tissue approximation

and/or ligation, including use in

ophthalmic procedures. Not for use

in cardiovascular and neurological

tissues.

Superficial soft tissue approximation

of skin and mucosa only. Not for use

in ligation, ophthalmic, cardiovascu-

lar or neurological procedures.

General soft tissue approximation

and/or ligation. Not for use in car-

diovascular and neurological tissues,

microsurgery, or ophthalmic surgery.

General soft tissue approximation

and/or ligation, including use in

ophthalmic procedures. Not for use in

cardiovascular and neurological tissues.

All types of soft tissue approxima-

tion, including pediatric cardiovascu-

lar and ophthalmic procedures. Not

for use in adult cardiovascular tissue,

microsurgery, and neural tissue.

General soft tissue approximation

and/or ligation, including

cardiovascular, ophthalmic and

neurological procedures.

Abdominal wound closure, hernia

repair, sternal closure and orthoaedic

procedures including cerclage and

tendon repair.

General soft tissue approximation

and/or ligation, including

cardiovascular, ophthalmic and

neurological procedures.

General soft tissue approximation

and/or ligation, including

cardiovascular, ophthalmic and

neurological procedures.

General soft tissue approximation

and/or ligation, including

cardiovascular, ophthalmic and

neurological procedures.

General soft tissue approximation

and/or ligation, including

cardiovascular, ophthalmic and

neurological procedures.

General soft tissue approximation

and/or ligation, including

cardiovascular, ophthalmic and

neurological procedures.

General soft tissue approximation

and/or ligation, including

cardiovascular, ophthalmic and

neurological procedures.

COLOR CODE

OF PACKETS

Yellow

Beige

Violet and Red

Coral

Violet

Silver

Light Blue

Yellow-Ochre

Mint Green

Turquoise

Orange

Deep Blue

Royal Blue

HOW SUPPLIED

7-0 thru 3 with and without needles,

and on LIGAPAK dispensing reels

0 thru 1 with CONTROL

RELEASE needles

7-0 thru 3 with and without needles,

and on LIGAPAK dispensing reels

0 thru 1 with CONTROL

RELEASE needles

5-0 thru 1 with needles

6-0 thru 2 with and without needles

3-0 thru 1 with CONTROL

RELEASE needles

8-0 thru 3 with and without needles,

and on LIGAPAK dispensing reels

4-0 thru 2 with CONTROL RELEASE

needles; 8-0 with attached beads for

ophthalmic use

9-0 thru 2 with needles

4-0 thru 2 with CONTROL

RELEASE needles

9-0 thru 7-0 with needles

7-0 thru 1 with needles

9-0 thru 5 with and without needles,

and on LIGAPAK dispensing reels

4-0 thru 1 with CONTROL

RELEASE needles

10-0 thru 7 with and without needles

11-0 thru 2 with and without needles

6-0 thru 1 with and without needles

4-0 thru 1 with CONTROL

RELEASE needles

6-0 thru 5 with and without needles

10-0 and 11-0 for ophthalmic (green

monofilament); 0 with CONTROL

RELEASE needles

7-0 thru 5 with and without needles

4-0 thru 1 with CONTROL

RELEASE needles; various sizes

attached to TFE polymer pledgets

6-0 thru 2 (clear) with and without

needles; 10-0 thru 8-0 and 6-0 thru 2

with and without needles; 0 thru 2 with

CONTROL RELEASE needles; various

sizes attached to TFE polymer pledgets

6-0 through 5-0 with TAPERCUT*

surgical needle

8-0 through 5-0 with taper point

needle

* Trademark

TABLE

may be used on peritoneum and/or

fascial layers of the abdominal wall

to provide a temporary seal during

the healing process.

INTERRUPTED SUTURES

Interrupted sutures use a number

of strands to close the wound.

Each strand is tied and cut after

insertion. This provides a more

secure closure, because if one

suture breaks, the remaining

sutures will hold the wound edges

in approximation.

Interrupted sutures may be

used if a wound is infected,

because microorganisms may be

less likely to travel along a series

of interrupted stitches.

DEEP SUTURES

Deep sutures are placed completely

under the epidermal skin layer.

They may be placed as continuous

or interrupted sutures and are not

removed postoperatively.

BURIED SUTURES

Buried sutures are placed so that the

knot protrudes to the inside, under

the layer to be closed. This tech-

nique is useful when using large

diameter permanent sutures on

deeper layers in thin patients who

may be able to feel large knots that

are not buried.

PURSE-STRING SUTURES

Purse-string sutures are continuous

sutures placed around a lumen and

tightened like a drawstring to

invert the opening. They may be

placed around the stump of the

appendix, in the bowel to secure an

intestinal stapling device, or in an

organ prior to insertion of a tube

(such as the aorta, to hold the

cannulation tube in place during

an open heart procedure).

SUBCUTICULAR SUTURES

Subcuticular sutures are continuous

or interrupted sutures placed in the

dermis, beneath the epithelial layer.

Continuous subcuticular sutures are

placed in a line parallel to the

wound. This technique involves

taking short, lateral stitches the full

length of the wound. After the

suture has been drawn taut, the

distal end is anchored in the same

manner as the proximal end. This

may involve tying or any of a

variety of anchoring devices.

Subcuticular suturing may be

performed with absorbable suture

which does not require removal, or

with monofilament nonabsorbable

suture that is later removed by

simply removing the anchoring

device at one end and pulling the

opposite end.

THE SUTURE

DEEP

SUTURES

FIGURE

PURSE-STRING

SUTURES

FIGURE

THE SECONDARY

SUTURE LINE

A secondary line of sutures may

be used:

• To reinforce and support the

primary suture line, eliminate

dead space, and prevent fluid

accumulation in an abdominal

wound during healing by first

intention. When used for this

purpose, they may also be called

retention, stay, or tension sutures.

• To support wounds for healing

by second intention.

• For secondary closure following

wound disruption when healing

by third intention.

NOTE: If secondary sutures are

used in cases of nonhealing, they

should be placed in opposite fashion

from the primary sutures

(i.e., interrupted if the primary

sutures were continuous,

continuous if the primary sutures

were interrupted).

Retention sutures are placed approxi-

mately 2 inches from each edge of

the wound. The tension exerted

lateral to the primary suture line

contributes to the tensile strength of

the wound. Through-and-through

sutures are placed from inside the

peritoneal cavity through all layers

of the abdominal wall, including the

peritoneum. They should be insert-

ed before the peritoneum is closed

using a simple interrupted stitch.

The wound may be closed in layers

for a distance of approximately

three-fourths its length. Then the

retention sutures in this area may be

drawn together and tied. It is

important that a finger be placed

within the abdominal cavity to

prevent strangulation of the viscera

in the closure. The remainder of the

wound may then be closed. Prior

to tightening and tying the final

retention sutures, it is important

to explore the abdomen again with

a finger to prevent strangulation

of viscera in the closure. The

remainder of the wound may then

be closed.

Retention sutures utilize

nonabsorbable suture material.

They should therefore be removed

as soon as the danger of sudden

increases in intra-abdominal

pressure is over— usually 2 to 6

weeks, with an average of 3 weeks.

STITCH PLACEMENT

Many types of stitches are used

for both continuous and interrupted

suturing. In every case, equal

"bites" of tissue should be taken

on each side of the wound. The

needle should be inserted from

1 to 3 centimeters from the edge

of the wound, depending upon the

type and condition of the tissue

being sutured.

CHAPTER 2 23

* Trademark

SUBCUTANEOUS

SUTURES

FIGURE

RETENTION

SUTURE

BOLSTER

FIGURE

KNOT TYING

Of the more than 1,400 different

types of knots described in THE

ENCYLCOPEDIA OF KNOTS,

only a few are used in modern

surgery. It is of paramount

importance that each knot placed

for approximation of tissues or

ligation of vessels be tied with

precision and each must hold with

proper tension.

KNOT SECURITY

The construction of ETHICON*

sutures has been carefully

designed to produce the optimum

combination of strength,

uniformity, and hand for each

material. The term hand is the

most subtle of all suture quality

aspects. It relates to the feel of the

suture in the surgeon’s hands, the

smoothness with which it passes

through tissue and ties down, the

way in which knots can be set and

snugged down, and most of all, to

the firmness or body of the suture.

Extensibility relates to the way in

which the suture will stretch slightly

during knot tying and then recover.

The stretching characteristics

provide the signal that alerts the

surgeon to the precise moment

when the suture knot is snug.

The type of knot tied will depend

upon the material used, the depth

and location of the incision, and the

amount of stress that will be placed

upon the wound postoperatively.

Multifilament sutures are generally

easier to handle and tie than

monofilament sutures, however, all

the synthetic materials require a

specific knotting technique. With

multifilament sutures, the nature of

the material and the braided or

twisted construction provide a high

coefficient of friction and the knots

remain as they are laid down. In

monofilament sutures, on the other

hand, the coefficient of friction is

relatively low, resulting in a greater

tendency for the knot to loosen

after it has been tied. In addition,

monofilament synthetic polymeric

materials possess the property of

memory. Memory is the tendency

not to lie flat, but to return to a

given shape set by the material’s

extrusion process or the suture’s

packaging. The RELAY* suture

delivery system delivers sutures with

minimal package memory due to its

unique package design.

Suture knots must be properly

placed to be secure. Speed in knot

tying frequently results in less than

perfect placement of the strands.

In addition to variables inherent in

the suture materials, considerable

variation can be found between

knots tied by different surgeons

and even between knots tied by

the same individual on different

occasions. The general principles

of knot tying which apply to all

suture materials are:

1. The completed knot must be

firm, and so tied that slipping is

virtually impossible. The

simplest knot for the material is

the most desirable.

2. The knot must be as small as

possible to prevent an excessive

amount of tissue reaction when

absorbable sutures are used, or to

minimize foreign body reaction

to nonabsorbable sutures. Ends

should be cut as short as possible.

3. In tying any knot, friction

between strands ("sawing") must

be avoided as this can weaken the

integrity of the suture.

4. Care should be taken to avoid

damage to the suture material

when handling. Avoid the

crushing or crimping application

of surgical instruments, such as

needleholders and forceps, to the

strand except when grasping the

free end of the suture during an

instrument tie.

5. Excessive tension applied by the

surgeon will cause breaking of

the suture and may cut tissue.

Practice in avoiding excessive

tension leads to successful use of

finer gauge materials.

6. Sutures used for approximation

should not be tied too tightly,

because this may contribute to

tissue strangulation.

THE SUTURE

COMMONLY

USED TYPES

OF STITCHES

To appose skin and other tissue

Over-and-over Over-and-over

Subcuticular Vertical mattress

Horizontal mattress

To invert tissue

Lembert Lembert

Cushing Halsted

Connell Purse-string

To evert tissue

Horizontal mattress Horizontal mattress

CONTINUOUS SUTURE INTERRUPTED SUTURES

TABLE

7. After the first loop is tied, it is

necessary to maintain traction

on one end of the strand to

avoid loosening of the throw if

being tied under any tension.

8. Final tension on final throw

should be as nearly horizontal

as possible.

9. The surgeon should not hesitate

to change stance or position in

relation to the patient in order

to place a knot securely and flat.

10. Extra ties do not add to the

strength of a properly tied and

squared knot. They only

contribute to its bulk. With

some synthetic materials, knot

security requires the standard

surgical technique to flat and

square ties with additional

throws if indicated by surgical

circumstance and the experience

of the surgeon.

KNOT TYING TECHNIQUES

MOST OFTEN USED

An important part of good suturing

technique is correct method in

knot tying. A seesaw motion, or

the sawing of one strand down over

another until the knot is formed,

may materially weaken sutures to

the point that they may break when

the second throw is made, or even

worse, in the postoperative period

when the suture is further weakened

by increased tension or motion. If

the two ends of the suture are

pulled in opposite directions with

uniform rate and tension, the knot

may be tied more securely.

Some procedures involve tying

knots with the fingers, using one or

two hands; others involve tying with

the help of instruments. Perhaps

the most complex method of knot

tying is done during endoscopic

procedures, when the surgeon must

manipulate instruments from well

outside the body cavity.

Following are the most frequently

used knot tying techniques with

accompanying illustrations of

finished knots.

SQUARE KNOT

The two-hand square knot is the

easiest and most reliable for tying

most suture materials. It may be

used to tie surgical gut, virgin silk,

surgical cotton, and surgical stain-

less steel. Standard technique of flat

and square ties with additional

throws if indicated by the surgical

circumstance and the experience of

the operator should be used to tie

MONOCRYL* (poliglecaprone 25)

suture, coated VICRYL*

(polyglactin 910) suture, coated

VICRYL* RAPIDE (polyglactin

910) suture, PDS* II (polydiox-

anone) suture, ETHILON* nylon

suture, ETHIBOND* EXCEL

polyester suture, PERMA-HAND*

silk suture, PRONOVA* poly

(hexafluoropropylene-VDF)

suture, and PROLENE*

polypropylene suture.

Wherever possible, the square

knot is tied using the two-hand

technique. On some occasions it

will be necessary to use one hand,

either the left or the right, to tie a

square knot.

CAUTION: If the strands of a

square knot are inadvertently

incorrectly crossed, a granny knot

will result. Granny knots are not

recommended because they have a

tendency to slip when subjected to

increased stress.

CHAPTER 2 25

* Trademark

FIGURE

FINISHED

SUTURE

TIES

Square knot

Surgeon’s knot–first

throw

Surgeon’s knot–second

throw

Deep tie

Instrument tie

SURGEON’S OR

FRICTION KNOT

The surgeon's or friction knot is

recommended for tying Coated

VICRYL* (polyglactin 910) suture,

ETHIBOND* EXCEL polyester

suture, ETHILON* nylon suture,

MERSILENE* polyester fiber

suture, NUROLON* nylon suture,

PRONOVA* poly (hexafluoro-

propylene-VDF) suture, and

PROLENE* polypropylene

suture. The surgeon’s knot also

may be performed using a

one-hand technique.

DEEP TIE

Tying deep in a body cavity can be

difficult. The square knot must be

firmly snugged down as in all

situations. However, the operator

must avoid upward tension which

may tear or avulse the tissue.

LIGATION USING A

HEMOSTATIC CLAMP

Frequently it is necessary to ligate

a blood vessel or tissue grasped in

a hemostatic clamp to achieve

hemostasis in the operative field.

INSTRUMENT TIE

The instrument tie is useful when

one or both ends of the suture

material are short. For best results,

exercise caution when using a

needleholder with any monofila-

ment suture, as repeated bending

may cause these sutures to break.

ENDOSCOPIC KNOT

TYING TECHNIQUES

During an endoscopic procedure,

a square knot or surgeon's knot may

be tied either outside the abdomen

and pushed down into the body

through a trocar (extracorporeal)

or directly within the abdominal

cavity (intracorporeal).

In extracorporeal knot tying, the

suture appropriately penetrates the

tissue, and both needle and suture

are removed from the body cavity,

bringing both suture ends outside

of the trocar. Then a series of

half-hitches are tied, each one

being pushed down into the cavity

and tightened with an endoscopic

knot pusher.

Intracorporeal knot tying is

performed totally within the

abdominal cavity. After the suture

has penetrated the tissue, the needle

is cut from the suture and removed.

Several loops are made with the

suture around the needleholder,

and the end of the suture is pulled

through the loops. This technique

is then repeated to form a surgeon's

knot, which is tightened by the

knot pusher.

In both extracorporeal and intracor-

poreal knot tying, the following

principles of suture manipulation

on tissue should be observed:

1. Handle tissue as gently as

possible to avoid tissue trauma.

2. Grasp as little tissue as possible.

3. Use the smallest suture possible

for the task.

4. Exercise care in approximating

the knot so that the tissue being

approximated is not strangulated.

5. Suture must be handled with care

to avoid damage.

CUTTING THE

SECURED SUTURES

Once the knot has been securely

tied, the ends must be cut. Before

cutting, make sure both tips of

the scissors are visible to avoid

inadvertently cutting tissue beyond

the suture.

Cutting sutures entails running

the tip of the scissors lightly down

the suture strand to the knot.

The ends of surgical gut are left

relatively long, approximately 1/4"

(6mm) from the knot. Other

materials are cut closer to the

knot, approximately 1/8" (3mm),

to decrease tissue reaction and

minimize the amount of foreign

material left in the wound. To

ensure that the actual knot is not

cut, twist or angle the blades of the

scissors prior to cutting.

Make certain to remove the

cut ends of the suture from the

operative site.

SUTURE REMOVAL

When the external wound has

healed so that it no longer needs the

support of nonabsorbable suture

material, skin sutures must be

removed. The length of time the

sutures remain in place depends

upon the rate of healing and the

nature of the wound. General rules

are as follows.

THE SUTURE

SUTURE

REMOVAL

Skin on the face and neck 2 to 5 days

Other skin sutures 5 to 8 days

Retention sutures 2 to 6 weeks

SUTURE LOCATION TIME FOR SUTURE REMOVAL TABLE

Sutures should be removed using

aseptic and sterile technique. The

surgeon uses a sterile suture removal

tray prepared for the procedure.

The following steps are taken:

• STEP 1—Cleanse the area with

an antiseptic. Hydrogen peroxide

can be used to remove dried serum

encrusted around the sutures.

•STEP 2—Pick up one end of the

suture with thumb forceps, and

cut as close to the skin as possible

where the suture enters the skin.

•STEP 3—Gently pull the suture

strand out through the side oppo-

site the knot with the forceps. To

prevent risk of infection, the

suture should be removed without

pulling any portion that has been

outside the skin back through

the skin.

NOTE: Fast absorbing synthetic or

gut suture material tend to lose all

tensile strength in 5 to 7 days and

can be removed easily without

cutting. A common practice is

to cover the skin sutures with

PROXI-STRIP* skin closures

during the required healing period.

After the wound edges have

regained sufficient tensile strength,

the sutures may be removed by

simply removing the PROXI-STRIP

skin closures.

SUTURE

HANDLING TIPS

These guidelines will help the surgi-

cal team keep their suture inventory

up to date and their sutures in the

best possible condition.

1. Read labels.

2. Heed expiration dates and

rotate stock.

3. Open only those sutures needed

for the procedure at hand.

4. Straighten sutures with a gentle

pull. Never crush or rub them.

5. Don't pull on needles.

6. Avoid crushing or crimping

suture strands with surgical

instruments.

7. Don't store surgical gut

near heat.

8. Moisten—but never soak—

surgical gut.

9. Do not wet rapidly absorbing

sutures.

10. Keep silk dry.

11. Wet linen and cotton to increase

their strength.

12. Don't bend stainless steel wire.

13. Draw nylon between gloved

fingers to remove the packaging

"memory."

14. Arm a needleholder properly.

SUTURE SELECTION

PROCEDURE

PRINCIPLES OF

SUTURE SELECTION

The surgeon has a choice of suture

materials from which to select for

use in body tissues. Adequate

strength of the suture material will

prevent suture breakage. Secure

knots will prevent knot slippage.

But the surgeon must understand

the nature of the suture material,

the biologic forces in the healing

wound, and the interaction of

the suture and the tissues. The

following principles should guide

the surgeon in suture selection.

1. When a wound has reached

maximal strength, sutures are no

longer needed. Therefore:

a. Tissues that ordinarily heal

slowly such as skin, fascia,

and tendons should usually

be closed with nonabsorbable

sutures. An absorbable suture

with extended (up to 6

months) wound support may

also be used.

b. Tissues that heal rapidly

such as stomach, colon and

bladder may be closed with

absorbable sutures

2. Foreign bodies in potentially

contaminated tissues may convert

contamination into infection.

CHAPTER 2 27

* Trademark

ARMING

A NEEDLE-

HOLDER

PROPERLY

FIGURE

Grasp the needle one-third to one-half of the distance from

the swaged end to the point.

3. Where cosmetic results are

important, close and prolonged

apposition of wounds and

avoidance of irritants will

produce the best results.

Therefore:

a. Use the smallest inert

monofilament suture

materials such as nylon

or polypropylene.

b. Avoid skin sutures and close

subcuticularly whenever

possible.

c. Under certain circumstances,

to secure close apposition of

skin edges, a topical skin

adhesive or skin closure

tape may be used.

4. Foreign bodies in the presence

of fluids containing high concen-

trations of crystalloids may act

as a nidus for precipitation and

stone formation.

Therefore:

a. In the urinary and biliary

tracts, use rapidly absorbed

sutures.

5. Regarding suture size:

a. Use the finest size suture

commensurate with the

natural strength of the tissue.

b. If the postoperative course of

the patient may produce

sudden strains on the suture

line, reinforce it with

retention sutures. Remove

them as soon as the patient’s

condition is stabilized.

SURGERY WITHIN THE

ABDOMINAL WALL CAVITY

Entering the abdomen, the surgeon

will need to seal or tie off

subcutaneous blood vessels

immediately after the incision is

made, using either an electrosurgical

unit designed for this purpose or

free ties (ligatures). If ligatures are

used, an absorbable suture material

is generally preferred. When

preparing the ties, the scrub person

often prepares one strand on a

needle for use as a suture ligature

should the surgeon wish to

transfix a large blood vessel.

Once inside, the type of suture

selected will depend upon the

nature of the operation and the

surgeon's technique.

THE GASTROINTESTINAL TRACT

Leakage from an anastomosis

or suture site is the principal

problem encountered performing

a procedure involving the

gastrointestinal tract. This problem

can lead to localized or generalized

peritonitis. Sutures should not be

tied too tightly in an anastomotic

closure. Wounds of the stomach and

intestine are rich in blood supply

and may become edematous and

hardened. Tight sutures may cut

through the tissue and cause

leakage. A leak-proof anastomosis

can be achieved with either a

single or double-layer closure.

For a single-layer closure, interrupt-

ed sutures should be placed

approximately 1/4" (6mm) apart.

Suture is placed through the

submucosa, into the muscularis and

through the serosa. Because the

submucosa provides strength in

the gastrointestinal tract, effective

closure involves suturing the

submucosal layers in apposition

without penetrating the mucosa.

A continuous suture line provides a

tighter seal than interrupted sutures.

However, if a continuous suture

breaks, the entire line may separate.

Many surgeons prefer to use a

double-layer closure, placing a

second layer of interrupted sutures

through the serosa for insurance.

Absorbable VICRYL* sutures, or

chromic gut sutures may be used

in either a single or double-layer

closure. Surgical silk may also be

used for the second layer of a

double-layer closure.

Inverted, everted, or end-to-end

closure techniques have all been

used successfully in this area, but

they all have drawbacks. The

surgeon must take meticulous care

in placing the sutures in the submu-

cosa. Even with the best technique,

some leakage may occur.

Fortunately, the omentum usually

confines the area, and natural body

defenses handle the problem.

THE STOMACH

For an organ that contains free

hydrochloric acid and potent

proteolytic enzymes, the stomach

heals surprisingly quickly.

Stomach wounds attain maximum

strength within 14 to 21 days

postoperatively, and have a peak

rate of collagen synthesis at 5 days.

Absorbable sutures are usually

acceptable in the stomach, although

they may produce a moderate

reaction in both the wound and

normal tissue. Coated VICRYL*

sutures are most commonly used.

PROLENE* sutures may also be

used for stomach closure.

THE SMALL INTESTINE

Closure of the small intestine

presents the same considerations

as the stomach. Proximal intestinal

contents, primarily bile or

pancreatic juices, may cause a

THE SUTURE

severe chemical (rather than

bacterial) peritonitis.

If using an inverted closure

technique, care must be taken to

minimize the cuff of tissue which

protrudes into the small sized

intestinal lumen in order to avoid

partial or complete obstruction.

Absorbable sutures are usually

preferred, particularly because they

will not permanently limit the

lumen diameter. A nonabsorbable

suture may be used in the serosal

layer for added assurance.

The small intestine heals very

rapidly, reaching maximal strength

in approximately 14 days.

THE COLON

The high microbial content of

the colon once made contamination

a major concern. But absorbable

sutures, once absorbed, leave no

channel for microbial migration.

Still, leakage of large bowel

contents is of great concern as it

is potentially more serious than

leakage in other areas of the

gastrointestinal tract.

The colon is a strong organ—

approximately twice as strong in the

sigmoid region as in the cecum. Yet,

wounds of the colon gain strength

at the same rate regardless of their

location. This permits the same

suture size to be used at either end

of the colon. The colon heals at a

rate similar to that of the stomach

and small intestine. A high rate of

collagen synthesis is maintained for

a prolonged period (over 120 days).

The entire gastrointestinal tract

exhibits a loss of collagen and

increased collagenous activity

immediately following colon

anastomosis. Both absorbable and

nonabsorbable sutures may be used

for closure of the colon. Placement

of sutures in the submucosa,

avoiding penetration of the mucosa,

will help prevent complications.

THE RECTUM

The rectum heals very slowly.

Because the lower portion is below

the pelvic peritoneum, it has no

serosa. A large bite of muscle should

be included in an anastomosis, and

the sutures should be tied carefully

to avoid cutting through the tissues.

Monofilament sutures reduce the

risk of bacterial proliferation in

the rectum.

THE BILIARY TRACT

THE GALLBLADDER

Within the gallbladder, the cystic

and common bile ducts heal rapidly.

Their contents present special

considerations for suture selection.

The presence of a foreign body such

as a suture in an organ that is prone

to crystal formation may precipitate

the formation of "stones."

Multifilament sutures should

probably not be used because it

is not always possible to prevent

exposure of a suture in the ducts.

The surgeon should choose an

absorbable suture in the finest size

possible that leaves the least surface

area exposed.

CHAPTER 2 29

* Trademark

ANASTOMOTIC

CLOSURE

TECHNIQUE

INVERTED

CLOSURE

TECHNIQUE

FIGURE

Single layer Double layer

PARENCHYMATOUS ORGANS

THE SPLEEN, LIVER AND KIDNEY

On occasion, a surgeon may be

called upon to repair a laceration

of one of these vital organs. If

large vessels, particularly arteries,

within these organs have been

severed, they must be located

and ligated before attempting

to close the defect. Otherwise,

hematomas or secondary hemor-

rhage may occur.

Because these organs are composed

chiefly of cells with little connective

tissue for support, attempts must

be made to coapt the outer fibrous

capsule of the torn tissue. In

the absence of hemorrhage, little

tension is placed on the suture line

and only small size sutures need to

be used. If the tissue cannot be

approximated, tacking a piece of

omentum over the defect will

usually suffice to provide closure.

Sutures do not need to be placed

close together or deeply into

the organ.

Lacerations in this area tend to

heal rapidly. New fibrous tissue will

usually form over the wound with

7 to 10 days.

In a liver resection, suturing of the

wedges in a horizontal through-

and-through fashion should hold

the tissue securely. Large vessels

should be tied using VICRYL*

sutures or silk. Raw surfaces can be

closed or repaired using VICRYL

(polyglactin 910) mesh.

CLOSING THE ABDOMEN

When closing the abdomen, the

closure technique may be more

important than the type of suture

material used.

THE PERITONEUM

The peritoneum, the thin membra-

nous lining of the abdominal cavity,

lies beneath the posterior fascia. It

heals quickly. Some believe that the

peritoneum does not require sutur-

ing, while others disagree. If the

posterior fascia is securely closed,

suturing the peritoneum may not

contribute to the prevention of an

incisional hernia. Among surgeons

who choose to close the peri-

toneum, a continuous suture line

with absorbable suture material

is usually preferred. Interrupted

sutures can also be used for

this procedure.

FASCIA

This layer of firm, strong connective

tissue covering the muscles is the

main supportive structure of the

body. In closing an abdominal

incision, the fascial sutures must

hold the wound closed and

also help to resist changes in intra-

abdominal pressure. Occasionally,

synthetic graft material may be

used when fascia is absent or weak.

PROLENE* polypropylene mesh may

be used to replace abdominal wall

or repair hernias when a great deal

of stress will be placed on the suture

line during healing. Nonabsorbable

sutures such as PROLENE suture

may be used to suture the graft to

the tissue.

THE SUTURE

LIVER

RESECTION

FIGURE

THE

ABDOMINAL

WALL

FIGURE

Skin

Subcutaneous fat

Peritoneum

Muscle tissue

Transversalis fascia

Fascia regains approximately 40%

of its original strength in 2 months.

It may take up to a year or longer to

regain maximum strength. Full

original strength is never regained.

The anatomic location and type of

abdominal incision will influence

how may layers of fascia will be

sutured. The posterior fascial layer

is always closed. The anterior layer

may be cut and may also require

suturing. Mass closure techniques

are becoming the most popular.

Most suture materials have some

inherent degree of elasticity. If not

tied too tightly, the suture will

"give" to accommodate postopera-

tive swelling that occurs. Stainless

steel sutures, if tied too tightly, will

cut like a knife as the tissue swells

or as tension is placed upon the

suture line. Because of the slow

healing time and because the fascial

suture must bear the maximum

stress of the wound, a moderate size

nonabsorbable suture may be used.

An absorbable suture with longer

lasting tensile strength, such as

PDS* II sutures, may also provide

adequate support. PDS II sutures

are especially well-suited for use in

younger, healthy patients.

Many surgeons prefer the use of

interrupted simple or figure-of eight

sutures to close fascia, while others

employ running suture or a

combination of these techniques.

In the absence of infection or gross

contamination, the surgeon may

choose either monofilament or

multifilament sutures. In the

presence of infection, a

monofilament absorbable material

like PDS II sutures or inert nonab-

sorbable sutures like stainless steel or

PROLENE* sutures may be used.

MUSCLE

Muscle does not tolerate suturing

well. However, there are several

options in this area.

Abdominal muscles may be either

cut, split (separated), or retracted,

depending upon the location and

type of the incision chosen. Where

possible, the surgeon prefers to

avoid interfering with the blood

supply and nerve function by

making a muscle-splitting incision

or retracting the entire muscle

toward its nerve supply. During

closure, muscles handled in this

manner do not need to be sutured.

The fascia is sutured rather than

the muscle.

The Smead-Jones far-and-near-

technique for abdominal wound

closure is strong and rapid, provides

good support during early healing

with a low incidence of wound

disruption, and has a low incidence

of late incisional problems. This is

a single-layer closure through both

layers of the abdominal wall fascia,

abdominal muscles, peritoneum,

and the anterior fascial layer. The

interrupted sutures resemble a

"figure of eight" when placed.

Absorbable PDS II sutures or

VICRYL* sutures are usually used.

Stainless steel sutures may also be

used. Monofilament PROLENE

sutures also provide all the

advantages of steel sutures: strength,

minimal tissue reactivity, and resist-

ance to bacterial contamination.

They are better tolerated than steel

sutures by patients in the late post-

operative months and are easier for

the surgeon to handle and tie.

However, both stainless steel and

PROLENE sutures may be

detectable under the skin of thin

patients. To avoid this problem,

knots should be buried in fascia

instead of in the subcutaneous

space.

CHAPTER 2 31

SURGICAL

OPTIONS IN

MUSCLE

FIGURE

Cutting Splitting Retracting

* Trademark

SUBCUTANEOUS FAT

Neither fat nor muscle tolerate

suturing well. Some surgeons

question the advisability of placing

sutures in fatty tissue because it

has little tensile strength due to

its composition, which is mostly

water. However, others believe it

is necessary to place at least a

few sutures in a thick layer of

subcutaneous fat to prevent dead

space, especially in obese patients.

Dead spaces are most likely to

occur in this type of tissue, so

the edges of the wound must be

carefully approximated. Tissue

fluids can accumulate in these

pocket-like spaces, delaying healing

and predisposing infection.

Absorbable sutures are usually

selected for the subcutaneous layer.

VICRYL* suture is especially suited

for use in fatty, avascular tissue since

it is absorbed by hydrolysis. The

surgeon may use the same type and

size of material used earlier to ligate

blood vessels in this layer.

SUBCUTICULAR TISSUE

To minimize scarring, suturing

the subcuticular layer of tough

connective tissue will hold the skin

edges in close approximation. In a

single-layer subcuticular closure, less

evidence of scar gaping or expansion

may be seen after a period of 6 to 9

months than is evident with simple

skin closure. The surgeon takes

continuous short lateral stitches

beneath the epithelial layer of skin.

Either absorbable or nonabsorbable

sutures may be used. If nonab-

sorbable material is chosen, one end

of the suture strand will protrude

from each end of the incision, and

the surgeon may tie them together

to form a "loop" or knot the ends

outside of the incision.

To produce only a hair-line scar

(on the face, for example), the

skin can be held in very close

approximation with skin closure

tapes in addition to subcuticular

sutures. Tapes may be left on the

wound for an extended period of

time depending upon their location

on the body.

When great tension is not placed

upon the wound, as in facial or

neck surgery, very fine sizes of

subcuticular sutures may be used.

Abdominal wounds that must

withstand more stress call for larger

suture sizes.

Some surgeons choose to close

both the subcuticular and epidermal

layers to achieve minimal scarring.

Chromic surgical gut and polymeric

materials, such as MONOCRYL*

suture, are acceptable for placement

within the dermis. They are capable

of maintaining sufficient tensile

strength through the collagen

synthesis stage of healing which

lasts approximately 6 weeks. The

sutures must not be placed too

close to the epidermal surface to

reduce extrusion. If the skin is

nonpigmented and thin, a clear or

white monofilament suture such

as MONOCRYL suture will be

invisible to the eye. MONOCRYL

suture is particularly well-suited for

this closure because, as a monofila-

ment, it does not harbor infection

and, as a synthetic absorbable

suture, tissue reaction is minimized.

After this layer is closed, the skin

edges may then be approximated.

SKIN

Skin is composed of the epithelium

and the underlying dermis. It is so

tough that a very sharp needle is

essential for every stitch to minimize

tissue trauma. (See Chapter 3: The

Surgical Needle.)

Skin wounds regain tensile strength

slowly. If a nonabsorbable suture

material is used, it is typically

removed between 3 and 10 days

postoperatively, when the wound

has only regained approximately

5% to 10% of its strength. This is

possible because most of the stress

placed upon the healing wound is

absorbed by the fascia, which the

surgeon relies upon to hold the

wound closed. The skin or

subcuticular sutures need only be

strong enough to withstand natural

skin tension and hold the wound

edges in apposition.

The use of coated VICRYL*

RAPIDE suture, a rapidly absorbed

synthetic suture, eliminates the

need for suture removal. Coated

VICRYL RAPIDE suture, which

is indicated for superficial closure

of skin and mucosa, provides

short-term wound support

consistent with the rapid healing

characteristics of skin. The sutures

begin to fall off in 7 to 10 days,

with absorption essentially

complete at 42 days.

Suturing technique for skin

closure may be either continuous

or interrupted. Skin edges should

be everted. Preferably, each suture

strand is passed through the skin

only once, reducing the chance

of cross-contamination across the

entire suture line. Interrupted

technique is usually preferred.

THE SUTURE

If surgeon preference indicates

the use of a nonabsorbable suture

material, several issues must be

considered. Skin sutures are exposed

to the external environment,

making them a serious threat

to wound contamination and

stitch abscess. The interstices of

multifilament sutures may provide

a haven for microorganisms.

Therefore, monofilament nonab-

sorbable sutures may be preferred for

skin closure. Monofilament sutures

also induce significantly less tissue

reaction than multifilament sutures.

For cosmetic reasons, nylon or

polypropylene monofilament sutures

may be preferred. Many skin

wounds are successfully closed with

silk and polyester multifilaments

as well. Tissue reaction to nonab-

sorbable sutures subsides and

remains relatively acellular as

fibrous tissue matures and forms a

dense capsule around the suture.

(Note, surgical gut has been known

to produce tissue reaction. Coated

VICRYL* RAPIDE suture elicits

a lower tissue reaction than chromic

gut suture due to its accelerated

absorption profile.) The key to suc-

cess is early suture removal before

epithelialization of the suture tract

occurs and before contamination is

converted into infection.

A WORD ABOUT SCARRING

(EPITHELIALIZATION)

When a wound is sustained in

the skin—whether accidentally or

during a surgical procedure—the

epithelial cells in the basal layer at

the margins of the wound flatten

and move into the wound area.

They move down the wound edge

until they find living, undamaged

tissue at the base of the wound.

Then they move across the wound

bed to make contact with similar

cells migrating from the opposite

side of the wound. They move

down the suture tract after if has

been embedded in the skin. When

the suture is removed, the tract of

the epithelial cells remains.

Eventually, it may disappear, but

some may remain and form keratin.

A punctate scar is usually seen on

the skin surface and a "railroad

track" or "crosshatch" appearance

on the wound may result. This is

relatively rare if the skin sutures are

not placed with excessive tension

and are removed by the seventh

postoperative day.

The forces that create the distance

between the edges of the wound

will remain long after the sutures

have been removed. Significant

collagen synthesis will occur from

5 to 42 days postoperatively. After

this time, any additional gain in

tensile will be due to remodeling,

or crosslinking, of collagen fibers

rather than to collagen synthesis.

Increases in tensile strength will

continue for as long as 2 years, but

the tissue will never quite regain its

original strength.

CLOSURE WITH

RETENTION SUTURES

We have already discussed the

techniques involved with placing

retention sutures, and using them

in a secondary suture line. (See the

section on Suturing Techniques.)

Heavy sizes (0 to 5) of nonabsorbable

materials are usually used for

retention sutures, not for strength,

but because larger sizes are less likely

to cut through tissue when a sudden

rise in intra-abdominal pressure

occurs from vomiting, coughing,

straining, or distention. To prevent

the heavy suture material from

cutting into the skin under stress,

one end of the retention suture may

be threaded through a short length

of plastic or rubber tubing called a

bolster or bumper before it is tied. A

plastic bridge with adjustable

features may also be used to protect

the skin and primary suture line

and permit postoperative wound

management for patient comfort.

Properly placed retention sutures

provide strong reinforcement for

abdominal wounds, but also cause

the patient more postoperative pain

than does a layered closure. The

best technique is to use a material

with needles swaged on each end

CHAPTER 2 33

* Trademark

THE RAILROAD

TRACK SCAR

CONFIGURATION

FIGURE

(double-armed). They should be

placed from the inside of the wound

toward the outside skin to avoid

pulling potentially contaminated

epithelial cells through the entire

abdominal wall.

The ETHICON retention

suture line includes ETHILON*

sutures, MERSILENE* sutures,

ETHIBOND* EXCEL sutures, and

PERMA-HAND* sutures. Surgical

steel sutures may also be used.

Retention sutures may be left in

place for 14 to 24 days postopera-

tively. Three weeks is an average

length of time. Assessment of the

patient's condition is the controlling

factor in deciding when to remove

retention sutures.

SUTURE FOR DRAINS

If a drainage tube is placed in a

hollow organ or a bladder drain is

inserted, it may be secured to the

wall of the organ being drained

with absorbable sutures. The surgeon

may also choose to minimize the

distance between the organ and the

abdominal wall by using sutures to

tack the organ being drained to the

peritoneum and fascia.

Sutures may be placed around the

circumference of the drain, either

two sutures at 12 and 6 o'clock

positions, or four sutures at 12, 3,

6, and 9 o'clock positions, and

secured to the skin with temporary

loops. When the drain is no longer

needed, the skin sutures may be

easily removed to remove the drain.

The opening can be left open to

permit additional drainage until it

closes naturally.

A drainage tube inserted into the

peritoneal cavity through a stab

wound in the abdominal wall

usually is anchored to the skin with

one or two nonabsorbable sutures.

This prevents the drain from

slipping into or out of the wound.

SUTURE NEEDS IN OTHER

BODY TISSUES NEUROSURGERY

Surgeons have traditionally used an

interrupted technique to close the

galea and dura mater.

The tissue of the galea, similar to

the fascia of the abdominal cavity,

is very vascular and hemostatic.

Therefore, scalp hematoma is a

potential problem, and the surgeon

must be certain to close well.

The dura mater is the outermost of

the three meninges that protects the

brain and spinal cord. It tears with

ease and cannot withstand too

much tension. The surgeon may

drain some of the cerebrospinal

fluid to decrease volume, easing the

tension on the dura before closing.

If it is too damaged to close, a

patch must be inserted and sutured

in place.

Surgical silk is appropriate in this

area for its pliability and easy knot

tying properties. Unfortunately,

it elicits a significant foreign body

tissue reaction. Most surgeons have

switched to NUROLON* sutures

or coated VICRYL* sutures because

they tie easily, offer greater strength

than surgical silk, and cause less

tissue reaction. PROLENE* sutures

have also been accepted by surgeons

who prefer a continuous closure

technique, who must repair

potentially infected wounds, or

who must repair dural tears.

In peripheral nerve repair, precise

suturing often requires the aid of

an operating microscope. Suture

gauge and needle fineness must be

consistent with nerve size. After the

motor and sensory fibers are proper-

ly realigned, the epineurium (the

outer sheath of the nerve) is

sutured. The strength of sutures in

this area is less of a consideration

than the degree of inflammatory

and fibroplastic tissue reaction. Fine

sizes of nylon, polyester, and poly-

propylene are preferred.

MICROSURGERY

The introduction of fine sizes of

sutures and needles has increased

the use of the operating microscope.

ETHICON introduced the first

THE SUTURE

PLACEMENT

OF SUTURES

AROUND

A DRAIN

FIGURE

* Trademark

microsurgery sutures—ETHILON*

sutures—in sizes 8-0 through

11-0. Since then, the microsurgery

line has expanded to include

PROLENE* sutures and coated

VICRYL* sutures. Literally all

surgical specialties perform some

procedures under the operating

microscope, especially vascular and

nerve anastomosis.

OPHTHALMIC SURGERY

The eye presents special healing

challenges. The ocular muscles, the

conjunctiva, and the sclera have

good blood supplies; but the cornea

is an avascular structure. While

epithelialization of the cornea

occurs rapidly in the absence of

infection, full thickness cornea

wounds heal slowly. Therefore, in

closing wounds such as cataract

incisions, sutures should remain in

place for approximately 21 days.

Muscle recession, which involves

suturing muscle to sclera, only

requires sutures for approximately

7 days.

Nylon was the preferred suture

material for ophthalmic surgery.

While nylon is not absorbed,

progressive hydrolysis of nylon

in vivo may result in gradual loss of

tensile strength over time. Fine sizes

of absorbable sutures are currently

used for many ocular procedures.

Occasionally, the sutures are

absorbed too slowly in muscle

recessions and produce granulomas

to the sclera. Too rapid absorption

has, at times, been a problem in

cataract surgery. Because they

induce less cellular reaction than

surgical gut and behave dependably,

VICRYL sutures have proven useful

in muscle and cataract surgery.

While some ophthalmic surgeons

promote the use of a "no-stitch"

surgical technique, 10-0 coated

VICRYL (polyglactin 910) violet

monofilament sutures offer distinct

advantages. They provide the securi-

ty of suturing immediately follow-

ing surgery but eliminate the risks

of suture removal and related

endophthalmitis.

The ophthalmologist has many

fine size suture materials to choose

from for keratoplasty, cataract,

and vitreous retinal microsurgical

procedures. In addition to

VICRYL* sutures, other monofila-

ment suture materials including

ETHILON sutures, PROLENE

sutures, and PDS* II sutures may

be used. Braided material such as

virgin silk, black braided silk,

MERSILENE* sutures, and coated

VICRYL sutures are also available

for ophthalmic procedures.

UPPER ALIMENTARY

TRACT PROCEDURES

The surgeon must consider the

upper alimentary tract from the

mouth down to the lower

esophageal sphincter to be a

potentially contaminated area.

The gut is a musculomembranous

canal lined with mucus membranes.

Final healing of mucosal wounds

appears to be less dependent upon

suture material than on the wound

closure technique.

The oral cavity and pharynx

generally heal quickly if not

infected. Fine size sutures are

adequate in this area as the wound

is under little tension. Absorbable

sutures may be preferred. Patients,

especially children, usually find

them more comfortable. However,

the surgeon may prefer a monofila-

ment nonabsorbable suture under

certain circumstances. This option

causes less severe tissue reaction

than multifilament materials in

buccal mucosa, but also requires

suture removal following healing.

In cases involving severe periodonti-

tis, VICRYL periodontal mesh

may be used to promote tissue

regeneration, a technique that

enhances the regeneration and

attachment of tissue lost due to

periodontitis. VICRYL periodontal

mesh, available in several shapes and

sizes with a preattached VICRYL

CHAPTER 2 35

LAYERS

OF SUTURES

SURROUNDING

A DRAIN

FIGURE

Skin Galea

Skull

Brain Dura mater

ligature, is woven from the same

copolymer used to produce

absorbable VICRYL* suture. As a

synthetic absorbable, VICRYL*

periodontal mesh eliminates the

trauma associated with a second

surgical procedure and reduces the

risk of infection or inflammation

associated with this procedure.

The esophagus is a difficult organ

to suture. It lacks a serosal layer.

The mucosa heals slowly. The thick

muscular layer does not hold sutures

well. If multifilament sutures are

used, penetration through the

mucosa into the lumen should be

avoided to prevent infection.

RESPIRATORY

TRACT SURGERY

Relatively few studies have been

done on healing in the respiratory

tract. Bronchial stump closure

following lobectomy or pneumonec-

tomy presents a particular challenge.

Infection, long stumps, poor

approximation of the transected

bronchus, and incomplete closure

(i.e., air leaks) may lead to

bronchopleural fistula. Avoidance

of tissue trauma and maintenance

of the blood supply to the area of

closure are critical to healing. The

bronchial stump heals slowly, and

sometimes not at all. Unless it is

closed tightly with strong, closely

spaced sutures, air may leak into

the thoracic cavity.

Closure is usually achieved with

mechanical devices, particularly

staples. When sutures are used,

polypropylene monofilament nonab-

sorbable sutures are less likely to

cause tissue reaction or harbor

infection. Silk suture is also

commonly used. Surgeons usually

THE SUTURE

THE EYE

FIGURE

BRONCHIAL

STUMP

CLOSURE

FIGURE

THE UPPER

ALIMENTARY

CANAL

FIGURE

Ocular muscles

Conjunctiva

Cornea

Sclera

Esophagus

Oral cavity

avoid absorbable sutures because

they may permit secondary leakage

as they lose strength.

Monofilament nylon suture should

also be avoided because of its

potential for knot loosening.

CARDIOVASCULAR SURGERY

Although definitive studies are few,

blood vessels appear to heal rapidly.

Most cardiovascular surgeons prefer

to use synthetic nonabsorbable

sutures for cardiac and peripheral

vascular procedures. Lasting

strength and leakproof anastomoses

are essential. Wire sutures are used

on the sternum unless it is fragile,

in which case absorbable sutures

can be used.

VESSELS

Excessive tissue reaction to suture

material may lead to decreased

luminal diameter or to thrombus

formation in a vessel. Therefore,

the more inert synthetics including

nylon and polypropylene are

the materials of choice for vessel

anastomoses. Multifilament

polyester sutures allow clotting to

occur within the interstices which

helps to prevent leakage at the

suture line. The advantages of a

material such as ETHIBOND*

EXCEL sutures are its strength,

durability, and slippery surface

which causes less friction when

drawn through a vessel. Many

surgeons find that PROLENE*

sutures, PRONOVA* sutures, or

silk are ideal for coronary artery

procedures because they do not

"saw" through vessels.

Continuous sutures provide a more

leakproof closure than interrupted

sutures in large vessel anastomoses

CHAPTER 2 37

* Trademark

CONTINUOUS

STRAND

SUTURING

IN VASCULAR

SURGERY

FIGURE

THE BUNNELL

TECHNIQUE

FIGURE

SEATING A

HEART VALVE

WITH ETHIBOND

EXCEL SUTURE

FIGURE

because the tension along the

suture strand is distributed evenly

around the vessel's circumference.

Interrupted monofilament sutures

such as ETHILON* sutures,

PROLENE* sutures, or

PRONOVA* sutures are used for

microvascular anastomoses.

When anastomosing major vessels

in young children, special care

must be taken to anticipate the

future growth of the patient.

Here, the surgeon may use silk to

its best advantage, because it loses

much of its tensile strength after

approximately 1 year, and is usually

completely absorbed after 2 or more

years. Continuous polypropylene

sutures have been used in children

without adverse effects. The

continuous suture, when placed,

is a coil which stretches as the

child grows to accommodate the

changing dimensions of the blood

vessel. However, reports of stricture

following vessel growth have

stimulated interest in use of a suture

line which is one-half continuous,

one-half interrupted. Clinical

studies suggest that a prolonged

absorbable suture, such as PDS* II

suture, may be ideal, giving

adequate short-term support while

permitting future growth.

Following vascular trauma, mycotic

aneurysms from infection are

extremely serious complications.

A suture may act as a nidus for

an infection. In the presence of

infection, the chemical properties

of suture material can cause

extensive tissue damage which may

reduce the tissue's natural ability

to combat infection. Localized

sepsis can also spread to adjacent

vascular structures, causing necrosis

of the arterial wall. Therefore, the

surgeon may choose a monofilament

suture material that causes only a

mild tissue reaction and resists

bacterial growth.

VASCULAR PROSTHESES

The fixation of vascular prostheses

and artificial heart valves presents an

entirely different suturing challenge

than vessel anastomosis. The sutures

must retain their original physical

properties and strength throughout

the life of the patient. A prosthesis

never becomes completely incorpo-

rated into the tissue and constant

movement of the suture line occurs.

Coated polyester sutures are the

choice for fixation of vascular

prostheses and heart valves because

they retain their strength and

integrity indefinitely.

Either a continuous or interrupted

technique may be used for vessel to

graft anastomoses.

To assist in proper strand identifica-

tion, many surgeons alternate green

and white strands of ETHIBOND*

EXCEL suture around the cuff of

the valve before tying the knots.

Some surgeons routinely use

pledgets to buttress sutures in valve

surgery. They are used most

commonly in valve replacement

procedures to prevent the annulus

from tearing when the prosthetic

valve is seated and the sutures are

tied. They may also be used in heart

wall closure of penetrating injuries,

excising aneurysms, vascular graft

surgery, and to add support when

the surgeon encounters extreme

deformity, distortion, or tissue

destruction at the annulus.

URINARY TRACT SURGERY

Closure of tissues in the urinary

tract must be leakproof to prevent

escape of urine into surrounding

tissues. The same considerations

that affect the choice of sutures for

the biliary tract affect the choice of

sutures for this area. Nonabsorbable

sutures incite the formation of cal-

culi, and therefore cannot be used.

Surgeons use absorbable sutures as a

rule, especially MONOCRYL*

sutures, PDS II sutures, Coated

VICRYL* sutures, and chromic

gut sutures.

The urinary tract heals rapidly. The

transitional cell epithelium migrates

over the denuded surfaces quickly.

Unlike other epithelium, the

migrating cells in the urinary tract

undergo mitosis and cell division.

Epithelial migration may be found

along suture tracts in the body of

the bladder. The bladder wall

regains 100% of its original tensile

strength within 14 days. The rate of

collagen synthesis peaks at 5 days

and declines rapidly thereafter.

Thus, sutures are needed for only

7 to 10 days.

THE FEMALE GENITAL TRACT

Surgery within this area presents

certain challenges. First, it is

usually regarded as a potentially

contaminated area. Second, the

surgeon must frequently work

within a very restricted field.

Endoscopic technique is frequently

used in this area.

Most gynecological surgeons prefer

to use absorbable sutures for repair of

incisions and defects. Some prefer

using heavy, size 1 surgical gut

sutures, MONOCRYL sutures, or

VICRYL sutures. However, the

THE SUTURE

stresses on the reproductive organs

and the rate of healing indicate that

these larger-sized sutures may only

be required for abdominal closure.

Handling properties, especially

pliability of the sutures used for

internal use, are extremely

important. Synthetic absorbable

sutures such as VICRYL* sutures in

size 0 may be used for the tough,

muscular, highly vascular tissues

in the pelvis and vagina. These

tissues demand strength during

approximation and healing. Coated

VICRYL* RAPIDE suture, for

example, is an excellent choice for

episiotomy repair.

TENDON SURGERY

Tendon surgery presents several

challenges. Most tendon injuries are

due to trauma, and the wound may

be dirty. Tendons heal slowly. The

striated nature of the tissue makes

suturing difficult.

Tendon repair fibroblasts are

derived from the peritendonous

tissue and migrate into the wound.

The junction heals first with scar

tissue, then by replacement with

new tendon fibers. Close apposition

of the cut ends of the tendon

(especially extensor tendons)

must be maintained to achieve

good functional results. Both the

suture material and the closure

technique are critical for successful

tendon repair.

The suture material the surgeon

chooses must be inert and strong.

Because tendon ends can separate

due to muscle pull, sutures with a

great degree of elasticity should be

avoided. Surgical steel is widely used

because of its durability and lack of

elasticity. Synthetic nonabsorbable

materials including polyester fibers,

polypropylene, and nylon may be

used. In the presence of potential

infection, the most inert monofila-

ment suture materials are preferred.

The suture should be placed to

cause the least possible interference

with the surface of the tendon, as

this is the gliding mechanism. It

should also not interfere with the

blood supply reaching the wound.

Maintenance of closed apposition

of the cut ends of the tendons,

particularly extensor tendons, is

critical for good functional results.

The parallel arrangement of tendon

fibers in a longitudinal direction

makes permanent and secure place-

ment of sutures difficult. Various

figure-of-eight and other types of

suturing have been used successfully

to prevent suture slippage and the

formation of gaps between the cut

ends of the tendon.

Many surgeons use the Bunnell

Technique. The suture is placed to

be withdrawn when its function as a

holding structure is no longer neces-

sary. Referred to as a pull-out suture,

it is brought out through the skin

and fastened over a polypropylene

button. The Bunnell Technique

suture can also be left in place.

NUROLON* sutures, PROLENE*

sutures, PRONOVA* sutures and

ETHIBOND* EXCEL sutures may

be used for connecting tendon to

bone. Permanent wire sutures also

yield good results because healing is

slow. In periosteum, which heals

fairly rapidly, surgical gut or coated

VICRYL sutures may be used. In

fact, virtually any suture may be

used satisfactorily in the periosteum.

SUTURES FOR BONE

In repairing facial fractures,

monofilament surgical steel has

proven ideal for its lack of elasticity.

Facial bones do not heal by callus

formation, but more commonly by

fibrous union. The suture material

must remain in place for a long

period of time—perhaps months—

until the fibrous tissue is laid down

and remodeled. Steel sutures

immobilize the fracture line and

keep the tissues in good apposition.

Following median stemotomy,

surgeons prefer interrupted steel

sutures to close. Sternum closure

may be difficult. Appropriate

tension must be maintained, and

the surgeon must guard against

weakening the wire. Asymmetrical

twisting of the wire may cause it to

buckle, fatiguing the metal, and

ultimately causing the wire to

break. Motion between the sides

of the sternum will result, causing

postoperative pain and possibly

dehiscence. Painful nonunion is

another possible complication.

(In osteoporotic patients, very

heavy VICRYL sutures may be

used to close the sternum securely.)

The surgeon may use a bone anchor

to hold one end of a suture in place

when needed (e.g., shoulder repair

surgery). This involves drilling a

hole in the bone and inserting

the anchor, which expands once

completely inside the bone to keep

it from being pulled out.

OTHER PROSTHETIC DEVICES

Often, it is necessary for the sur-

geon to implant a prosthetic device

such as an automatic defibrillator or

drug delivery system into a patient.

To prevent such a device from

CHAPTER 2 39

* Trademark

migrating out of position, it may be

tacked to the fascia or chest wall

with nonabsorbable sutures.

CLOSING CONTAMINATED

OR INFECTED WOUNDS

Contamination exists when

microorganisms are present, but in

insufficient numbers to overcome

the body's natural defenses.

Infection exists when the level of

contamination exceeds the

tissue's ability to defend against the

invading microorganisms. Generally,

contamination becomes infection

when it reaches approximately 106

bacteria per gram of tissue in an

immunologically normal host.

Inflammation without discharge

and/or the presence of culture-posi-

tive serous fluid indicate possible

infection. Presence of purulent dis-

charge indicates positive infection.

Contaminated wounds can

become infected when hematomas,

necrotic tissue, devascularized tissue,

or large amounts of devitalized

tissue (especially in fascia, muscle,

and bone) are present. Micro-

organisms multiply rapidly under

these conditions, where they are

safe from cells that provide local

tissue defenses.

In general, contaminated wounds

should not be closed but should be

left open to heal by secondary

intention because of the risk of

infection. Foreign bodies, including

sutures, perpetuate localized

infection. Therefore, the

surgeon's technique and choice of

suture is critical.

Nonabsorbable monofilament nylon

sutures are commonly used in

anticipation of delayed closure of

dirty and infected wounds. The

sutures are laid in but not tied.

Instead, the loose suture ends are

held in place with PROXI-STRIP*

skin closures (sterile tape). The

wound should be packed to

maintain a moist environment.

When the infection has subsided,

the surgeon can easily reopen the

wound, remove the packing and

any tissue debris, and then close

using the previously inserted

monofilament nylon suture.

IN THE

NEXT SECTION

The surgeon depends as much upon

the quality and configuration of the

needle used as on the suturing

material itself to achieve a successful

closure. The relationship between

needles and sutures will be explored

on the pages that follow.

THE SUTURE

TACKING A

PROSTHETIC

DEVICE IN

POSITION TO

PREVENT

MIGRATION

FIGURE

THE SURGICAL NEEDLE

CHAPTER 3

Necessary for the placement of

sutures in tissue, surgical needles

must be designed to carry suture

material through tissue with

minimal trauma. They must be

sharp enough to penetrate tissue

with minimal resistance. They

should be rigid enough to resist

bending, yet flexible enough to

bend before breaking. They must

be sterile and corrosion-resistant

to prevent introduction of

microorganisms or foreign bodies

into the wound.

Comfort with needle security in the

needleholder, the ease of passage

through tissue, and the degree of

trauma that it causes all have an

impact upon the overall results of

surgical needle performance. This is

especially true when precise cosmet-

ic results are desired.

The best surgical needles are:

• Made of high quality stainless

steel.

• As slim as possible without

compromising strength.

• Stable in the grasp of a

needleholder.

• Able to carry suture material

through tissue with minimal

trauma.

• Sharp enough to penetrate tissue

with minimal resistance.

• Rigid enough to resist bending,

yet ductile enough to resist

breaking during surgery.

• Sterile and corrosion-resistant

to prevent introduction of

microorganisms or foreign

materials into the wound.

Variations in needle geometries are

just as important as variations in

suture sizes. Needle dimensions

must be compatible with suture

sizes, allowing the two to work

in tandem.

ELEMENTS OF

NEEDLE DESIGN

Needle design involves analyzing a

surgical procedure and the density

of the tissue involved in great

detail. ETHICON engineers work

continuously to improve upon their

needle line, sometimes making sub-

tle alterations resulting in a positive

impact upon the procedure itself.

The various metal alloys used in the

manufacture of surgical needles

determine their basic characteristics

to a great degree. ETHICON*

stainless steel alloy needles are heat-

treated to give them the maximum

possible strength and ductility.

ETHALLOY* needle alloy (Patent

No. 5,000,912) was developed for

unsurpassed strength in precision

needles used in cardiovascular,

ophthalmic, plastic, and microsurgi-

cal procedures. It is produced

economically without sacrificing

ductility or corrosion resistance.

A needle's strength is determined

by how it resists deformation

during repeated passes through

tissue. Tissue trauma can be

induced if a needle bends during

penetration and compromises tissue

apposition. Therefore, greater needle

strength equals less tissue trauma.

A weak needle that bends too easily

can compromise the surgeon's

control and damage surrounding

tissue during the procedure. In

addition, loss of control in needle

placement could result in an

inadvertent needlestick.

Manufacturers measure needle

strength in the laboratory by

bending them 90° to determine the

needle's maximum strength. This is

referred to as the needle's "ultimate

moment," and is more important to

the needle manufacturer than to the

surgeon. The most critical aspect of

needle strength to the surgeon is

the "surgical yield" point. Surgical

yield indicates the amount of

angular deformation the needle

can with-stand before becoming

permanently deformed. This point

is usually 10° to 30° depending

upon the material and the manufac-

turing process. Any angle beyond

that point renders the needle

useless. Reshaping a bent needle

may cause it to lose strength

and be less resistant to bending

and breaking.

At ETHICON, the combination

of alloy selection and the needle

manufacturing process are carefully

selected to achieve the highest

possible surgical yield, which also

optimizes needle strength.

Ductility refers to the needle's

resistance to breaking under a given

amount of bending. If too great a

force is applied to a needle it may

break, but a ductile needle will

bend before breaking. Needle

breakage during surgery can prevent

apposition of the wound edges as

the broken portion passes through

tissue. In addition, searching for

part of a broken needle can cause

added tissue trauma and add to the

time the patient is anesthetized. A

piece that cannot be retrieved will

remain as a constant reminder to

THE SURGICAL NEEDLE

* Trademark

both the patient and surgeon.

Needle bending and breakage can

be minimized by carefully passing

needles through tissue in the

direction of the needle body.

Needles are not designed to be

used as retractors to lift tissue.

Needle sharpness is especially

important in delicate or cosmetic

surgery. The sharper the needle,

the less scarring that will result.

However, the right balance must be

found. If a needle is too sharp, a

surgeon may not feel he or she has

adequate control of needle passage

through tissue.

Sharpness is related to the angle of

the point as well as the taper ratio

of the needle. The ETHICON

sharpness tester incorporates a thin,

laminated, synthetic membrane

that simulates the density of human

tissue, allowing engineers to gauge

exactly how much force is required

for penetration.

Most ETHICON needles have

a micro-thin coating comprised

of silicone or similar lubricants

which significantly and measurably

improves ease of needle penetration.

According to laboratory tests, this

coating serves several important

functions:

✦It reduces the force needed to

make the initial penetration

through tissue.

✦It reduces the drag force on

the needle body as it passes

repeatedly through tissue.

Needle performance is also

influenced by the stability of the

needle in the grasp of a needlehold-

er. Most curved needles are

flattened in the grasping area to

enhance control. All ETHICON

curved needles of 22 mil wire

or heavier are ribbed as well as

flattened. Longitudinal ribbing

or grooves on the inside or outside

curvatures of curved needles

provides a crosslocking action in

the needleholder for added needle

control. This reduces undesirable

rocking, twisting, and turning in

the needleholder.

PRINCIPLES OF

CHOOSING A

SURGICAL NEEDLE

While there are no hard and fast

rules governing needle selection, the

following principles should be kept

in mind. (Specific types of needles

mentioned here will be described in

full detail later on in this section.)

1. Consider the tissue in which the

surgeon will introduce the

needle. Generally speaking, taper

point needles are most often used

to suture tissues that are easy

to penetrate. Cutting or

TAPERCUT* needles are

more often used in tough, hard-

to-penetrate tissues. When in

doubt about whether to choose

a taper point or cutting needle,

choose the taper point for

everything except skin sutures.

2. Watch the surgeon's technique

closely. Select the length,

diameter, and curvature of the

needle according to the desired

placement of the suture and the

space in which the surgeon

is working.

CHAPTER 3 43

TAPER

RATIO

FIGURE

ETHICON

RIBBED

NEEDLE

FIGURE

12:1 ratio

3. Consult frequently with the

surgeon. Working with the same

surgeon repeatedly leads to

familiarity with his or her

individual routine. However,

even the same surgeon may need

to change needle type or size to

meet specific requirements,

even during a single operative

procedure.

4. When using eyed needles, try to

match needle diameter to suture

size. Swaged needles, where the

needle is already attached to the

suture strand, eliminate this

concern.

5. The best general rule of thumb

for the scrub person to follow is

pay attention and remain alert to

the progress of the operation.

Observation is the best guide to

needle selection if the surgeon

has no preference.

THE ANATOMY

OF A NEEDLE

Regardless of its intended use,

every surgical needle has three basic

components:

✦The eye.

✦The body.

✦The point.

The measurements of these

specific components determine,

in part, how they will be used

most efficiently.

Needle size may be measured in

inches or in metric units. The

following measurements determine

the size of a needle.

✦CHORD LENGTH—The

straight line distance from the

point of a curved needle to

the swage.

✦NEEDLE LENGTH—The

distance measured along the

needle itself from point to end.

✦RADIUS—The distance from

the center of the circle to the

body of the needle if the

curvature of the needle were

continued to make a full circle.

✦DIAMETER—The gauge or

thickness of the needle wire.

Very small needles of fine gauge

are needed for microsurgery.

Large, heavy gauge needles are

used to penetrate the sternum

and to place retention sutures

in the abdominal wall. A broad

spectrum of sizes are available

between the two extremes.

THE SURGICAL NEEDLE

NEEDLE

COMPONENTS

FIGURE

ANATOMY

OF A NEEDLE

FIGURE

Point

Eye

(Swaged end)

Body

Needle

point

Chord length

Swage

Needle

radius

Needle length

Needle body

Needle

diameter

THE NEEDLE EYE

The eye falls into one of three cate-

gories: closed eye, French (split or

spring) eye, or swaged (eyeless).

The closed eye is similar to a

household sewing needle. The shape

of the eye may be round, oblong,

or square. French eye needles have a

slit from inside the eye to the end

of the needle with ridges that catch

and hold the suture in place.

Eyed needles must be threaded, a

time-consuming procedure for the

scrub person. This presents the

disadvantage of having to pull a

double strand of suture material

through tissue, creating a larger hole

with additional tissue disruption.

In addition, the suture may still

become unthreaded while the

surgeon is using it. While tying the

suture to the eye may minimize this

possibility, it also adds to the bulk

of the suture. Another disadvantage

of eyed needles is that repeated use

of these needles with more than

one suture strand causes the needle

to become dull, thereby making

suturing more difficult.

Virtually all needles used today are

swaged. This configuration joins

the needle and suture together as

a continuous unit—one that is

convenient to use and minimizes

trauma. The method of attaching

the suture to the needle varies with

the needle diameter. In larger

diameter needles, a hole is drilled

in the needle end. In smaller

diameter needles, a channel is

made by forming a "U" at the

swage end or a hole is drilled in

the wire with a laser. Each hole or

channel is specifically engineered

for the type and size of suture

material it will hold, and crimped

or closed around the suture to hold

it securely. When the surgeon has

finished placing the suture line in

the patient's tissue, the suture may

be cut, or easily released from the

needle as is the case when using

CONTROL RELEASE* needles

(Patent No. 3,980,177).

The diameter of a needle swaged

to suture material is no larger

than necessary to accommodate

the diameter of the suture strand

itself. Swaged sutures offer several

advantages to the surgeon, nurse,

and patient.

1. The scrub person does not have

to select a needle when the

surgeon requests a specific suture

material since it is already

attached.

2. Handling and preparation are

minimized. The strand with

needle attached may be used

directly from the packet. This

helps maintain the integrity of

the suture strand.

3. Tissues are subjected to minimal

trauma.

4. Tissue trauma is further reduced

because a new, sharp, undamaged

needle is provided with each

suture strand.

5. Swaged sutures do not unthread

prematurely.

6. If a needle is accidentally

dropped into a body cavity, the

attached suture strand makes it

easier to find.

7. Inventory and time spent

cleaning, sharpening, handling,

and sterilizing reusable eyed

needles is eliminated, thereby

reducing cost as well as risk of

needle punctures.

8. CONTROL RELEASE needles

allow placement of many sutures

rapidly. This may reduce

operating time and, ultimately,

the length of time the patient

is anesthetized.

9. The ATRALOC* surgical needle

and CONTROL RELEASE

needle ensure consistent quality

and performance.

10. Swaged sutures eliminate suture

fraying or damage due to sharp

comers in the eye of eyed

needles.

11. Needles are corrosion-free.

Small diameter ETHICON taper

point needles commonly used

in cardiovascular surgery were

compared in laboratory tests—

some with "split" channels and

some with laser-drilled holes. The

needles with laser-drilled holes

produced less drag force as they

passed through a membrane that

simulated vascular tissue. This

could be associated with less

trauma to the vessel walls.

The swaged ATRALOC surgical

needles made by ETHICON

are supplied in a variety of sizes,

shapes, and strengths. Some of

them incorporate the CONTROL

RELEASE needle suture principle

which facilitates fast separation

of the needle from the suture

when desired by the surgeon.

This feature allows rapid placement

of many sutures, as in interrupted

suturing techniques. Even though

the suture is securely fastened

to the needle, a slight, straight tug

will release it. This needle/suture

configuration was created originally

* Trademark

CHAPTER 3 45

for abdominal closure and

hysterectomies, but is now used

in a wide variety of procedures.

THE NEEDLE BODY

The body of the needle is the

portion which is grasped by the

needleholder during the surgical

procedure. The body of the needle

should be as close as possible to the

diameter of the suture material to

minimize bleeding and leakage.

This is especially true for

cardiovascular, gastrointestinal,

and bladder procedures.

The curvature of the needle body

may come in a variety of different

shapes. Each shape gives the needle

different characteristics.

STRAIGHT NEEDLE

This shape may be preferred when

suturing easily accessible tissue.

Most of these needles are designed

to be used in places where direct

finger-held manipulation can easily

be performed.

The Keith needle is a straight

cutting needle. It is used primarily

for skin closure of abdominal

wounds. Varying lengths are also

used for arthroscopic suturing of

the meniscus in the knee.

Bunnell (BN) needles are used for

tendon repair. Taper point needle

variations may also be used for

suturing the gastrointestinal tract.

Some microsurgeons prefer straight

needles for nerve and vessel repair.

In ophthalmology, the straight tran-

schamber needle protects endothe-

lial cells and facilitates placement of

intraocular lenses.

HALF-CURVED NEEDLE

The half-curved or "ski" needle

may be used for skin closure or in

laparoscopy. Its low profile allows

easy passage down laparoscopic

trocars. Its use in skin closure is

limited because, while the curved

portion passes through tissue easily,

the remaining straight portion of

the body is unable to follow the

curved path of the needle without

bending or enlarging its path in

the tissue.

CURVED NEEDLE

Curved needles allow predictable

needle turnout from tissue, and

are therefore used most often.

THE SURGICAL NEEDLE

FIGURE

THE NEEDLE EYE

Closed eye

French eye

Swaged

CONTROL

RELEASE

NEEDLE

SUTURE

FIGURE

Holding the needle securely in the needleholder, the suture

should be grasped securely and pulled straight and taut. The

needle will be released with a straight tug of the needleholder.

* Trademark

This needle shape requires less

space for maneuvering than a

straight needle, but the curve

necessitates manipulation with a

needleholder. The curvature may

be 1/4, 3/8, 1/2, or 5/8circle.

The most common use for the 3/8

circle is skin closure. The surgeon

can easily manipulate this curvature

with slight pronation of the wrist in

a relatively large and superficial

wound. It is very difficult to use

this needle in a deep body cavity or

restricted area because a larger arc of

manipulation is required.

The 1/2circle needle was designed

for use in a confined space,

although it requires more pronation

and supination of the wrist. But

even the tip of this needle may

be obscured by tissue deep in

the pelvic cavity. A 5/8circle

needle may be more useful in

this situation, especially in some

anal, urogenital, intraoral, and

cardiovascular procedures.

COMPOUND

CURVED NEEDLE

The compound curved needle

(Patent No. 4,524,771) was

originally developed for anterior

segment ophthalmic surgery. It

allows the surgeon to take precise,

uniform bites of tissue. The tight

80° curvature of the tip follows into

a 45° curvature throughout the

remainder of the body. The initial

curve allows reproducible, short,

deep bites into the tissue. The

curvature of the remaining portion

of the body forces the needle out of

the tissue, everting the wound edges

and permitting a view into the

wound. This ensures equidistance of

the suture material on both sides of

the incision. Equalized pressure on

both sides of the comeal-scleral

junction minimizes the possibility

of astigmatism following anterior

segment surgery.

THE NEEDLE POINT

The point extends from the extreme

tip of the needle to the maximum

cross-section of the body. Each nee-

dle point is designed and produced

to the required degree of sharpness

to smoothly penetrate specific types

of tissue.

TYPES OF

NEEDLES

CUTTING NEEDLES

Cutting needles have at least two

opposing cutting edges. They are

sharpened to cut through tough,

difficult-to-penetrate tissue.

Cutting needles are ideal for skin

sutures that must pass through

dense, irregular, and relatively

thick connective dermal tissue.

CHAPTER 3 47

NEEDLE

SHAPES

AND TYPICAL

APPLICATIONS

FIGURE

Straight

Half-curved

1/4Circle

3/8Circle

1/2Circle

5/8Circle

Compound

Curved

gastrointestinal tract, nasal

cavity, nerve, oral cavity,

pharynx, skin, tendon, vessels

skin (rarely used)

laparoscopy

eye (primary application)

microsurgery

aponeurosis, biliary tract, cardiovascular

system, dura, eye, gastrointestinal tract,

muscle, myocardium, nerve, perichon-

drium, periosteum, pleura, skin, tendon,

urogenital tract, vessels

biliary tract, cardiovascular system, eye,

fascia, gastrointestinal tract, muscle,

nasal cavity, oral cavity, pelvis, peri-

toneum, pharynx, pleura, resporatory

tract, skin, tendon, subcutaneous fat,

urogenital tract

anal (hemorrhoidectomy), nasal

cavity, pelvis, urogenital tract (primary

application)

eye (anterior segment)

laparoscopy

SHAPE APPLICATION

Because of the sharpness of the

cutting edge, care must be taken

in some tissue (tendon sheath

or oral mucous membrane) to

avoid cutting through more tissue

than desired.

CONVENTIONAL

CUTTING NEEDLES

In addition to the two cutting edges,

conventional cutting needles have a

third cutting edge on the inside

concave curvature of the needle.

The shape changes from a triangular

cutting blade to that of a flattened

body on both straight and curved

needles. This needle type may be

prone to cutout of tissue because

the inside cutting edge cuts toward

the edges of the incision or wound.

The PC PRIME* needle (Precision

Cosmetic, Patent No. 5,030,228)

is designed specifically for aesthetic

plastic surgery, and has conventional

cutting edges. Where cosmetic

results are important, the PC

PRIME needle is superior to any

other for more delicate surgery,

especially facial surgery. The

narrow point, fine wire diameter,

and fine taper ratio allow superior

penetration of soft tissue. The inside

and outside curvatures of the body

are flattened in the needle grasping

area for greater stability in the

needleholder. Fattened sides reduce

bending that might occur due to

the fine wire diameter.

The tip configuration of the conven-

tional cutting sternotomy needle is

slightly altered to resist bending as it

penetrates the sternum. The alloy

used for this needle provides the

increased strength and ductility need-

ed for its function. The cutting edges

of the point extend approximately

THE SURGICAL NEEDLE

NEEDLE

POINTSAND

BODY SHAPES

AND TYPICAL

APPLICATIONS

FIGURE

Conventional Cutting

Reverse Cutting

Precision Point Cutting

PC PRIME* Needle

MICRO-POINT* Reverse Cutting Needle

Side-Cutting Spatula

CS ULTIMA* Ophthalmic Needle

Taper

TAPERCUT* Surgical Needle

Blunt

skin, sternum

fascia, ligament, nasal cavity, oral

mucosa, pharynx, skin, tendon sheath

skin (plastic or cosmetic)

eye

eye (primary application),

microsurgery, ophthalmic

(reconstructive)

eye (primary application)

aponeurosis, biliary tract, dura, fascia,

gastrointestinal tract, laparoscopy,

muscle, myocardium, nerve, peritoneum,

pleura, subcutaneous fat, urogenital

tract, vessels, valve

bronchus, calcified tissue, fascia,

laparoscopy, ligament, nasal cavity,

oral cavity, ovary, perichondrium,

periosteum, pharynx, sternum, tendon,

trachea, uterus, valve, vessels (sclerotic)

Blunt dissection (friable tissue),

cervix (ligating incompetent cervix),

fascia, intestine, kidney, liver, spleen

SHAPE APPLICATION

Point

Body

Point

Body

1/4" (6mm) from the round body

and terminate in a triangular-shaped

tip. This particular sternotomy needle

maximizes cutting efficiency and con-

trol in the needleholder. TAPERCUT

surgical needles may also be used for

this procedure.

REVERSE CUTTING

NEEDLES

These needles were created

specifically for tough, difficult-to-

penetrate tissue such as skin, tendon

sheath, or oral mucosa. Reverse

cutting needles are used in

ophthalmic and cosmetic surgery

where minimal trauma, early

regeneration of tissue, and little scar

formation are primary concerns.

The reverse cutting needle is as

sharp as the conventional cutting

needle, but its design is distinctively

different. The third cutting edge

is located on the outer convex

curvature of the needle. This offers

several advantages:

✦Reverse cutting needles have

more strength than similar-sized

conventional cutting needles.

✦The danger of tissue cutout is

greatly reduced.

✦The hole left by the needle leaves

a wide wall of tissue against

which the suture is to be tied.

The MICRO-POINT* surgical

needle for ophthalmic procedures

has a smooth surface and is honed

to extreme sharpness. This allows

the surgeon to suture the extremely

tough tissues of the eye with

optimum precision and ease.

A needle manufactured by the

exclusive ETHICON* Precision

Point Process may be used for

plastic or cosmetic surgery, and

passes smoothly through tissue

creating a minute needle path.

This results in superior apposition.

The bottom third cutting edge

on the Precision Point needle

flattens out as it transitions to the

needle body for greater security in

the needleholder.

The OS (Orthopaedic Surgery)

needles are curved, heavy bodied,

reverse-cutting needles. The

orthopaedic surgeon may use the

OS needle for extremely tough

tissue, such as cartilage, where force

is required for penetration.

SIDE CUTTING NEEDLES

Also referred to as spatula needles,

they feature a unique design which

is flat on both the top and bottom,

eliminating the undesirable tissue

cutout of other cutting needles.

The side-cutting edges are designed

for ophthalmic procedures. They

permit the needle to separate or

split through the thin layers of

scleral or comeal tissue and travel

within the plane between them.

The optimal width, shape, and

precision sharpness of this needle

ensure maximum ease of penetra-

tion, and gives the surgeon greater

* Trademark

CHAPTER 3 49

THE PC

PRIME

NEEDLE

FIGURE

STERNOTOMY

NEEDLE

FIGURE

Narrow point

Fine wire diameter

Flattened inside curvature

Flattened outside curvature

Conventional

cutting tip

Flat sides

Conventional cutting edges (1/4 inch or 6mm)

control of the needle as it passes

between or through tissue layers.

The position of the point varies

with the design of each specific

type of spatulated needle.

The SABRELOC* spatula needle

has two cutting edges and a

trapezoidal-shaped body.

The SABRELOC* needle with

the cobra-shaped tip has four

equidistant defined edges.

The CS ULTIMA* ophthalmic

needle (Corneal-Scleral, Patent No.

5,002,564) is the sharpest needle

in its category and is used for

corneal scleral closure. The smaller

angles and increased cutting-edge

length result in superior sharpness

facilitating easy tissue penetration.

The TG PLUS* needle (Transverse

Ground) has a long, ultra-sharp,

slim tip. This needle undergoes a

unique honing process which results

in a sharper needle. The surgeon

encounters low penetration resist-

ance with the TG PLUS needle, and

gets excellent tactile feedback.

TAPER POINT NEEDLES

Also referred to as round needles,

taper point needles pierce and

spread tissue without cutting it. The

needle point tapers to a sharp tip.

The needle body then flattens to an

oval or rectangular shape. This

increases the width of the body to

help prevent twisting or turning in

the needleholder.

Taper point needles are usually

used in easily penetrated tissue

such as the peritoneum, abdominal

viscera, myocardium, dura, and

subcutaneous layers. They are

preferred when the smallest possible

hole in the tissue and minimum

tissue cutting are desired. They are

also used in internal anastomoses

to prevent leakage which can

subsequently lead to contamination

of the abdominal cavity. In the

fascia, taper point needles minimize

the potential for tearing the thin

connective tissue lying between

parallel and interlacing bands of

denser, connective tissue.

The Mayo (MO) needle has a taper

point, but a heavier and more

flattened body than conventional

taper needles. This needle was

designed for use in dense tissue;

particularly for gynecological

procedures, general closure, and

hernia repair.

TAPERCUT SURGICAL

NEEDLES

ETHICON* manufactures TAPER-

CUT* needles which combine the

features of the reverse cutting edge

tip and taper point needles. Three

cutting edges extend approximately

1/32" back from the point. These

blend into a round taper body. All

three edges are sharpened to provide

THE SURGICAL NEEDLE

REVERSE

CUTTING

NEEDLE

FIGURE

SPATULA

NEEDLE

CROSS-

SECTION

FIGURE

* Trademark

uniform cutting action. The point,

sometimes referred to as a trocar

point, readily penetrates dense,

tough tissue. The objective should

be for the point itself not to exceed

the diameter of the suture material.

The taper body portion provides

smooth passage through tissue and

eliminates the danger of cutting

into the surrounding tissue.

Although initially designed for

use in cardiovascular surgery on

sclerotic or calcified tissue, the

TAPERCUT* needle is widely

used for suturing dense, fibrous

connective tissue— especially in

fascia, periosteum, and tendon

where separation of parallel

connective tissue fibers could occur

with a conventional cutting needle.

ETHICON* developed a modified

TAPERCUT CC needle (Calcified

Coronary) for anastomosis of small

fibrotic and calcified blood vessels.

The calcified portion of an artery

requires a cutting tip only for initial

penetration to avoid tearing the

vessel. This needle configuration has

a slimmer geometry than other

TAPERCUT needles from the body

through the point which facilitates

penetration. It also minimizes the

risk of leakage from friable vessels

or vascular graft material.

BLUNT POINT NEEDLES

Blunt point (BP) needles can

literally dissect friable tissue rather

than cutting it. They have a taper

body with a rounded, blunt point

that will not cut through tissue.

They may be used for suturing the

liver and kidney. Due to safety

considerations, surgeons also use

blunt point needles in obstetric

and gynecological procedures when

working in deep cavities which

are prone to space and visibility

limitations. In addition, blunt

point needles for general closure are

especially helpful when performing

procedures on at-risk patients.

The ETHIGUARD* blunt point

needle combines the safety of the

blunt point with the security of a

ribbed and flattened design, and the

convenience of a swaged needle.

NEEDLEHOLDERS

The surgeon uses the needleholder

to pass a curved needle through

tissue. It must be made of noncor-

rosive, high strength, good quality

steel alloy with jaws designed for

holding the surgical needle securely.

CHAPTER 3 51

ETHICON

NEEDLE

CODES

& OTHER

MEANING

BB Blue Baby

BIF Intraocular Fixation

BN Bunnell

BP Blunt Point

BV Blood Vessel

BVH Blood Vessel Half

CCardiovascular

CC Calcified Cornary

CCS Conventional Cutting Sternotomy

CE Cutting Edge

CFS Conventional for Skin

CIF Cutting Intraocular Fixation

CP Cutting Point

CPS Conventional Plastic Surgery

CPX Cutting Point Extra Large

CS Corneal-Scleral

CSB Corneal-Scleral Bi-Curve

CSC Corneal-Scleral Compound Curve

CT Circle Taper

CTB Circle Taper Blunt

CTX Circle Taper Extra Large

CTXB Circle Taper Extra Large Blunt

CV Cardiovascular

DC Dura Closure

DP Double Point

EN Endoscopic Needle

EST Eyed Straight Taper

FN For Tonsil

FS For Skin

FSL For Skin Large

CODE MEANING

FSLX For Skin Extra Large

G Greishaber

GS Greishaber Spatula

JConjunctive

KS Keith Straight

LH Large Half

LR Larger Retention

LS Large Sternotomy

MMuscle

MF Modified Fergusan

MH Medium Half (circle)

MO Mayo

MOB Mayo Blunt

OPS Ocular Plastic Surgery

OS Orthopaedic Surgery

PPlastic

PC Precision Cosmetic

PS Plastic Surgery

RB Renal (artery) Bypass

RD Retinal Detachment

RH Round Half (circle)

RV Retinal-Vitreous

SSpatula

SC Straight Cutting

SFS Spatulated for Skin

SH Small Half (circle)

SIF Ski Intraocular Fixation

SKS Sternotomy Keith Straight

SM Spatulated Module

ST Straight Taper

CODE MEANING

STB Straight Blunt

STC Straight Cutting

STP Straight Taper Point

TE Three-Eighths

TF Tetralogy of Fallot

TG Transverse Ground

TGW Transverse Ground Wide

TN Trocar Needle

TP Taper Pericostal / Point

TPB Taper Pericostal /Point Blunt

TS Tendon Straight

TQ Twisty Q

UCL 5/8 Circle Colateral Ligament

UR Urology

URB Urology Blunt

VTAPERCUT Surgical Needle

VAS Vas Deferens

X or P Exodontal (dental)

XLH Extra Large Half (circle)

XXLH Extra Extra Large Half (circle)

CODE MEANING

TABLE

Needleholder jaws may be short or

flat, concave or convex, smooth or

serrated. Smooth jaws may allow the

needle to wobble or twist. Jaws with

teeth hold most securely but may

damage the suture or needle if too

much pressure is applied. Most, but

not all, needleholders have a ratchet

lock near to thumb and finger rings.

Surgical needles are designed for

optimum needleholder stability.

Because this tool actually drives the

needle, its performance will have an

impact upon the entire suturing

procedure. The surgeon has maxi-

mum control only when the needle

sits well in the holder without wob-

bling as it is passed through tissue.

Needleholders, like pliers, weaken

with repeated use. Therefore, the

scrub person should check before

each procedure to make sure that

the needleholder jaws align properly

and grasp securely.

When selecting a needleholder,

the following should be taken

into consideration:

✦It must be the appropriate size

for the needle selected. A very

small needle should be held with

small, fine jaws. The larger and

heavier the needle, the wider and

heavier the jaws of the needle-

holder should be.

✦It should be an appropriate size

for the procedure. If the surgeon

is working deep inside the body

cavity, a longer needleholder is

in order.

NEEDLEHOLDER USE

The following guidelines are offered

to the scrub person for needleholder

use:

1. Grasp the needle with the tip of

the needleholder jaws in an area

approximately one-third to

one-half of the distance from the

swaged end to the point. Avoid

placing the holder on or near the

swaged area which is the weakest

part of the needle.

2. Do not grasp the needle too

tightly as the jaws of the needle-

holder may deform, damage, or

bend it irreversibly.

3. Always check alignment of the

needleholder jaw to make certain

the needle does not rock, twist,

or turn.

4. Handle the needle and needle-

holder as a unit.

5. Pass the needleholder to the

surgeon so that he or she will not

have to readjust it before placing

the suture in tissue. Make sure

the needle is pointing in the

direction in which it will be

used and that the suture strand is

not entangled.

6. Always provide a needleholder—

never a hemostat—to pull the

needle out through tissue. A

hemostat or other clamp can

damage the needle.

7. Immediately after use, every

needle should be returned to the

scrub person while clamped in a

needleholder. Needles are less

likely to be lost if they are passed

one-for-one (one returned for

each one received).

PLACING THE NEEDLE

IN TISSUE

The actual placement of the

needle in the patient's tissue can

cause unnecessary trauma if done

incorrectly. Keep the following in

mind during suturing:

1. Apply force in the tissue to be

sutured in the same direction as

the curve of the needle.

2. Do not take excessively large bites

of tissue with a small needle.

3. Do not force a dull needle

through tissue. Take a new

needle.

THE SURGICAL NEEDLE

REVERSE

CUTTING

NEEDLE

FIGURE

Smooth Jaws Jaws with tungsten

carbide particles

Jaws with

teeth

* Trademark

4. Do not force or twist the needle

in an effort to bring the point

out through the tissue. Withdraw

the needle completely and then

replace it in the tissue, or use a

larger needle.

5. Avoid using the needle to bridge

or approximate tissues for

suturing.

6. Do not damage taper points or

cutting edges when using the

needleholder to pull the needle

through tissue. Grasp as far back

on the body as possible.

7. Depending upon the patient, the

tissue may be tougher or more

fibrous than anticipated and

require the use of a heavier gauge

needle. Conversely, a smaller

needle may be required when

tissue is more friable than usual.

8. In a deep, confined area, ideal

positioning of the needle may

not be possible. Under these

circumstances, proceed with

caution. A heavier gauge needle

or a different curvature may help

and a second needleholder

should be used to locate a needle

in a confined body cavity.

9. If a glove is punctured by a

needle, the needle must be

discarded immediately and the

glove must be changed for the

safety of the patient, as well as

the surgical team. Appropriate

serological testing of the patient

should be undertaken for

transmissable agents such as

hepatitis B and C and HIV.

NEEDLE

HANDLING TIPS

Needles should be protected from

bacterial contamination and damage

during handling by adhering to the

following guidelines:

1. Open needle packets and prepare

sutures carefully, protecting

needle sharpness.

2. Make sure the needle is free

of corrosion.

3. If using eyed needles, make sure

they do not have rough or sharp

edges inside the eye to fray or

break suture strands. Also check

the eyes for burrs or bluntness to

ensure easy penetration and

passage through tissue.

4. If a needle is defective, discard it.

5. Pass needles on an exchange

basis; one is passed to the

surgeon for one returned.

6. Employ the nontransfer

technique to avoid inadvertent

needlesticks: the surgeon places

the needle and needleholder

down in a neutral area of the

sterile field; the scrub person

then picks up the needleholder.

7. Secure each needle as soon as it is

used. Do not allow needles to lie

loose on the sterile field or Mayo

stand. Keep them away from

sponges and tapes so they will

not inadvertently be dragged into

the wound.

CHAPTER 3 53

PLACEMENT

OF THE

NEEDLE IN

TISSUE

1. The surgeon receives the

needleholder with the needle

point toward the thumb to

prevent unnecessary wrist

motion. The scrub person

controls the free end of the

suture to prevent dragging it

across the sterile field, and to

keep the suture from entering

the surgeon’s hand along

with the needleholder.

2. The surgeon begins closure

with theswaged suture.

3. The needle is passed into the tissue. The surgeon releases the

needle from the holder and reclamps the holder onto the body of the

needle near the point end to pull the needle and strand through

tissue. The needle is released or cut from the suture strand. The

surgeon leaves the needle clamped in the same position and returns

it to the scrub person. The scrub person immediately passes another

prepared suture to the surgeon, one-for-one.

FIGURE

THE SURGICAL NEEDLE

8. If a needle breaks, all pieces must

be accounted for.

9. Count all needles before and after

use according to hospital

procedure. Retain the packets

containing descriptive informa-

tion on quantity and needle type

for swaged needles to help

determine if all are accounted for.

Follow these steps for safe needle

handling:

1. Use sterile adhesive pads with or

without magnets or disposable

magnetic pads to facilitate

counting and safe disposal.

2. Swaged needles can be inserted

through or into their original

packet after use. An empty

packet indicates a missing needle.

If using an E-PACK* procedure

kit, compare the count of needles

used to the number preprinted

on the kit label.

3. Return eyed needles to the needle

rack. If eyed needles are to be

reused, they must be cleaned and

reprocessed at the end of the

operation.

4. Do not collect used needles in a

medicine cup or other container

since they must then be handled

individually to count them. This

can potentially contaminate

gloves and increase the risk of an

accidental puncture.

5. Discard used needles in a

"sharps" container.

IN THE

NEXT SECTION

In the section that follows, the

dual role that suture and needle

packaging plays will be covered.

Packaging does much more than

keep the needle and suture sterile.

Package design can help or

seriously hinder the efficiency of

the surgical procedure.

PACKAGING

CHAPTER 4

AN INTEGRAL PART

OF THE PRODUCT

The purpose of a package is to

protect its contents and provide

convenience to the user.

ETHICON* wound closure

packaging is an integral part of

each product. Over the past half a

century, packaging has evolved

from glass tubes packed in jars,

to multi-layered foil and paper

packages, to new materials that

reflect concern for both the

environment and the individuals

who must maintain operative

sterility and efficiency. Packaging

has kept pace with the technological

developments of wound closure

products themselves. Several factors

have influenced these developments:

✦Increasing product diversity

✦Technological advances in

packaging materials

✦Stringent regulatory requirements

To prevent infection in an operative

wound, all instruments and supplies

that come in contact with the

wound must be sterile (free of

living microorganisms and spores)

including sutures, needles, ligating

clips, stapling instruments, adhesive

tapes and topical skin adhesives.

High standards and criteria are set

for all components in the packaging

of sterile products:

1. Protect and preserve product

stability and sterility from

potential deterioration from

outside forces such as oxygen,

moisture, light, temperature,

dust, and vermin.

2. Prevent product damage or

microbial contamination in

transit and storage.

3. Provide identifiable product

information.

4. Permit convenient, safe, and

sterile transfer of the product

from the package to the

sterile field.

5. Meet the functional needs of all

members of the surgical team.

RELAY* SUTURE

DELIVERY SYSTEM

Most suture materials are packaged

and sterilized by the manufacturer.

They arrive ready for use in boxes

which can be stored until needed.

The RELAY* suture delivery system,

developed by ETHICON with

human, clinical, and environmental

factors in mind, stores and delivers

sutures in a time-efficient manner

and reduces unnecessary handling

to access sutures. The system

also provides control over suture

storage, usage, inventory rotation,

needle counting, and cost contain-

ment. The RELAY suture system

consists of three basic, interrelated

components: modular suture

storage racks, dispenser boxes,

and primary packets.

MODULAR STORAGE RACKS

The modular storage racks are

designed for maximum convenience

and versatility to meet the individ-

ual needs of a particular specialty,

nurse, surgeon, or department.

Modules can be easily assembled

to accommodate both vertical and

horizontal suture dispenser boxes.

Any number of modules can be

fastened together to meet both

small and large storage needs.

Once assembled, the racks may be

used on shelves, mounted on walls,

placed on mobile carts, or

connected to IV poles. Racks can

also be fitted with a rotating base

for more convenient access, as well

as with a handle for easy carrying.

PACKAGING

ETHICON

MODULAR

STORAGE

RACKS

FIGURE

Full-vertical boxes Half-vertical boxes

Horizontal boxes Combination of boxes

Each module has a built-in

inventory control area to facilitate

restocking. This feature enables

unused suture packets to be

systematically fed back into the

proper rotational flow without

mixing lots within the boxes.

Sutures may be grouped within

the modular system by material

type or size, or by use (i.e., general

closure, gastrointestinal surgery,

plastic surgery, etc.).

DISPENSER BOXES

Gravity-fed dispenser boxes dispense

suture packets from the opening at

the bottom of the box. The opening

can accommodate the removal of

several suture packets at one time.

All ETHICON* dispenser boxes

are made of recyclable paper

and printed with either water or

soy-based inks. Each box provides

clear product identification through

streamlined graphics, product

color coding, bold label copy,

and descriptive symbols. The

information required for quick

reference and easy selection of

suture materials is highlighted in a

logical sequence. The three most

important criteria necessary for

proper identification and suture

selection are:

1. Suture size

2. Suture material

3. Type and size of needle

Other important product

information found on all suture

boxes includes:

1. Surgical application

2. Product code number

3. Suture length and color

4. Metric diameter equivalent of

suture size and length

5. Shape and quantity of needles

(single- or double-armed, shown

by silhouette)

6. Needle point geometry

7. Lot number

8. Expiration date

A package insert with detailed infor-

mation about the suture material is

inserted in every dispenser box. Users

should be familiar with this informa-

tion as it contains FDA-approved

indications, contraindications, and

all appropriate warnings and precau-

tionary statements for each product.

Dispenser boxes should be restocked

when the last few suture packets

appear in the box opening, before

the box is completely empty. The

unused packets from the previous

box should be used before a new

dispenser box is opened. This will

help to avoid mixing lot numbers

and ensure proper stock rotation.

ETHICON advocates rotation

of the entire dispenser box. In

addition to ensuring the use of the

oldest suture materials first, this

helps to maintain a fresh stock of

dispenser boxes.

Most dispenser boxes contain

three dozen suture packets. Others

may contain one or two-dozen

packets. The product code number

suffix and a statement on the box

indicate the quantity of suture

packets in the box (product code

suffix G = 1 dozen, D = 1 dozen,

T = 2 dozen, H = 3 dozen). The

dispenser boxes are held securely for

easy dispensing by firmly pushing

the box into a "lock" in the back of

the rack module.

PRIMARY PACKETS

Individual sutures and multiple

suture strands are supplied sterile

within a primary packet. The

exterior surfaces of the overwrap are

not sterile. ETHICON primary

packaging is designed to permit fast

and easy opening in one peelable

motion. The single layer overwrap

of primary packaging is made of

either foil or coated Tyvek®on one

side heat-sealed to polyethylene film

on the other. Absorbable sutures are

always encased in foil to provide a

safe and durable moisture barrier

and to withstand sterilization in

the manufacturing process. Most

nonabsorbable sutures are encased

in coated Tyvek®overwraps.

In a continuous effort to be more

environmentally conscious,

ETHICON has chosen materials

in the manufacture of primary

packets which generate minimal

negative impact to the environment

upon incineration or disposal.

Furthermore, wherever possible,

the number of primary packaging

layers has been reduced by as

much as 50 percent, thus reducing

the volume of environmental waste

per OR procedure.

Each primary packet provides

critical product information and

the same color-coding as its

dispenser box. The packet also

identifies the product code number,

material, size, needle type, and the

number of needles per packet to

simplify needle counts.

Primary packets of suture material

may contain sutures in one of

five styles:

1. Standard lengths of non-needled

material: 54 inches (135cm) of

absorbable or 60 inches (150cm)

of nonabsorbable suture, which

may be cut in half, third, or

quarter lengths for ligating

or threading.

* Trademark

CHAPTER 4 57

2. SUTUPAK* pre-cut sterile suture

is nonneedled material for

ligating or threading. These

lengths may be supplied in a

multistrand labyrinth packet or

in a folder packet, both of which

are designed to deliver one strand

at a time. SUTUPAK sutures

may be removed from the packet

and placed in the suture book.

3. One single strand of material

with single- or double-armed

swaged needle(s). Needles for

one-step RELAY suture packets,

micro-surgery, and some

ophthalmic needles are secured in

a "needle park." The needle park

is designed to provide a standard

location for, and easy access to,

the needle. All other needles are

protected within an inner

folder or other specific channel

within a paper folder.

Most single strand needled

sutures are sealed in convenient

one-step RELAY delivery

packages. One-step RELAY pack-

ages allow the needle to be armed

in the needleholder from any

angle without touching the

needle. This increases the safety

of handling needles intraopera-

tively. If it is preferred to locate

the needle by hand, this can be

accomplished with the one-step

RELAY package by pushing up

the flap behind the needle park,

thereby elevating the needle so it

can be grasped by hand.

4. Multiple suture strands, either

swaged to a single needle or

double-armed. This type is

appropriate for procedures

requiring numerous interrupted

sutures of the same type. It saves

valuable operative time by

PACKAGING

MOST

COMMON

ETHICON

SUTURE

PACKAGING

TABLE

Surgical Gut Suture

Coated VICRYL* RAPIDE

(polyglactin 910) suture

Coated VICRYL*

(polyglactin 910) suture

MONOCRYL*

(poliglecaprone 25) suture

PDS* II

(polydioxanone) suture

PERMA-HAND* Silk Suture

Stainless Steel Suture

ETHILON* nylon suture

NUROLON* nylon suture

MERSILENE*

polyester fiber suture

ETHIBOND* EXCEL

polyester fiber suture

PROLENE* polypropylene suture

PRONOVA*

poly (hexafluoropropylene-VDF) suture

ABSORBABLE SUTURE LAYERS

Tyv ek ®overwrap, foil primary

package containing one-step

RELAY* suture delivery system tray

Tyv ek ®overwrap, foil primary package,

paper folder

Peelable foil overwrap, one-step

RELAY tray

Peelable foil overwrap, one-step

RELAY tray

Peelable foil overwrap, one-step

RELAY tray

Tyv ek ®overwrap, one-step RELAY tray

Tyv ek ®overwrap, paper folder

Peelable foil overwrap, one-step

RELAY tray

Tyv ek ®overwrap, one-step RELAY tray

NONABSORBABLE SUTURE LAYERS

Tyvek ®is a registered trademark of E.I. du Pont de Nemours and Company

METHOD FOR

PREPARING

ONE-STEP

RELAY

PACKAGE

SUTURES

FIGURE

Arm the needle directly from the one-step RELAY tray and

deliver the single suture to the surgeon.

* Trademark

enabling the surgeon to use one

suture while the next is being

armed—without delay of open-

ing packets or threading needles.

Multistrand packets are labeled

with the symbol MS/ that

denotes multiple strands/number

of strands of surgical needles per

packet. Multistrand packets may

contain 3 to 10 swaged sutures.

The inner folder for these

products is white.

All packets containing

CONTROL RELEASE* needle

sutures have multiple strands

(8, 5, 4, 3, or 1) and are

designated CR/8, CR/5, CR/4,

CR/3, or CR/1. CONTROL

RELEASE sutures may be

available in foil or Tyvek®

overwrap packets for single

strand delivery. The single strand

delivery folder is used for some

coated VICRYL* (polyglactin

910) sutures, MONOCRYL*

(poliglecaprone 25) sutures,

PDS* II (polydioxanone) sutures,

ETHIBOND* EXCEL polyester

sutures, NUROLON* nylon

sutures, MERSILENE* polyester

sutures, and PERMA-HAND*

silk sutures. The suture material

straightens as it is delivered from

the folder. Each suture may be

delivered to the surgeon individ-

ually from the opening packet or

removed from the folder and

placed in the suture book. The

inner folder for these products is

either red with a black C/R

symbol or white with red

lettering. The safety organizer

tray is used for coated VICRYL

sutures, MONOCRYL sutures,

PDS II sutures, ETHIBOND

EXCEL sutures, PERMA-HAND

silk sutures, NUROLON nylon

sutures, MERSILENE sutures,

and surgical gut sutures. The

safety organizer tray allows for

single strand arming and

dispensing. The needles are

situated in individually num-

bered needle parks and may be

armed and dispensed with little

or no hand-to-needle contact.

5. Ligating material used as either

single strand (free or freehand)

ties, or as continuous ties

unwound from a reel or other

device. The length of single

strand ties is determined by the

depth of the wound. In subcuta-

neous tissue, quarter lengths

(approximately 14 inches) are

usually long enough for ligating.

Single strand ligating material is

available in pre-cut lengths or 18,

24, and 30 inch strands.

Many surgeons prefer continuous

ties. Some prefer LIGAPAK*

ligature, which is supplied on

disc like plastic radiopaque

dispensing reels that are color

coded by material. The size of

the ligature material is indicated

by the number of holes visible on

the side of the reel (e.g., 3 holes=

3-0 suture). The reel is held in

the palm of the hand as blood

vessels are ligated. Other

surgeons may prefer the ligating

material rewound onto a rubber

reel, gauze sponge, metal bobbin,

or other device.

The number of packets of

ligating material required to tie

off subcutaneous vessels

(bleeders) will vary with patient

size and age, the amount of

bleeding, the type of operation,

the length of the incision, and

the surgical technique. An

abdominal incision 8 to 12

inches long might require

one to three packets to

ligate the subcutaneous

blood vessels.

All suture material is packaged

dry with the exception of surgical

gut and pliabilized ETHILON

sutures. Natural absorbable suture

materials are packaged with a

small amount of sterile fluid,

usually alcohol with water, to

maintain pliability. They should

therefore be opened over a basin to

prevent any solution from spilling

onto the sterile field.

All needles should be counted

after packets of swaged sutures

are opened, according to

established hospital procedure.

The packets should be retained

to facilitate verification of the

final needle count after the

surgical procedure.

E-PACK*

PROCEDURE KIT

The E-PACK procedure kit

contains numerous sutures and

other products for a specific

procedure, surgeon, or surgical

specialty. The packaging concept

saves valuable time in the OR by

eliminating the need to open and

coordinate multiple individual

suture packages. The E-PACK

procedure kit is also an effective

means of reducing inventory

levels of individual product

codes, and providing a record

for determining the suture

costs associated with a given

surgical procedure.

CHAPTER 4 59

PACKAGING

The suture packages are secured

in an organizer sleeve to facilitate

sterile transfer to the sterile field.

The procedure kit label provides all

the pertinent information regarding

the number and types of needles, as

well as sizes and types of suture.

Suture quantities are listed on the

label, making it easy to quickly

determine how many needles have

been used and thus simplifying

needle accountability at the end of

the procedure. The organizer sleeve

is delivered in a Tyvek®pouch.

EXPIRATION DATE

The expiration date of a product is

determined by product stability

studies. The Food and Drug

Administration (FDA) requires

that all synthetic absorbable suture

products have an expiration date

stamped on each dispenser box

and primary packet to indicate

the known shelf life of the material,

provided the physical integrity

of the package is maintained.

Tests conducted by ETHICON*

show conclusively that synthetic

absorbable suture products such

as Coated VICRYL* suture and

PDS* II suture continue to meet

all product requirements even at

five years of storage.

In addition, all ETHICON

nonabsorbable suture products

contain a five-year expiry dating

on each dispenser box and

primary packet. This expiry

dating is necessary to comply

with various international

regulatory guidelines and is an aid

in inventory management.

The RELAY suture delivery system

is designed as a "first-in, first-out"

inventory control system. Dispenser

boxes are rotated, permitting the

oldest sutures to be used first. The

expiration date stamped on the

outside of each box and every

packet clearly indicates the month

and year of product expiration.

SUTURE

STERII IZATION

Sutures sterilized by ETHICON are

either irradiated with cobalt 60 or

exposed to ethylene oxide gas. Both

processes alter proteins, enzymes,

and other cellular components to

the extent that microorganisms are

unable to survive or cause infection.

Irradiation and ethylene oxide gas

are considered cold sterilization

processes because radiation sterilizes

at room temperature and ethylene

oxide gas sterilizes at much lower

temperatures than other sterilization

methods such as dry heat or steam

under pressure.

Irradiation sterilization exposes

products to ionizing radiation—

either beta rays produced by high

energy electron accelerators or

gamma rays from radioisotopes—

until absorbed in appropriate

sterilizing dose. ETHICON was

a pioneer in both beta and

gamma irradiation and routinely

sterilizes products with cobalt

60 which emits gamma rays.

Cobalt 60 irradiation is the simplest

of all sterilization processes.

Some suture materials cannot

withstand the effects of irradiation

sterilization, becoming unusable.

Instead, they are gas sterilized.

Gas sterilization uses

ethylene oxide gas. As an environ-

mental measure, ETHICON

replaced chlorofluorocarbons

(CFCs) with more environmentally

friendly compounds in all gas

sterilization processes. The

combination of ethylene oxide

gas concentration, temperature,

humidity, and exposure time must

be carefully controlled to ensure

reliable sterilization.

WARNING: Surgical sutures are

labeled as disposable, single-use

medical devices. Suture products

manufactured by ETHICON are

provided in easy-to-use packages

designed to maintain the stability

and sterility of the suture and

needle materials. The component

layers of packaging materials do

not permit exposure to high

temperatures or extremes of pres-

sure without affecting package and

product integrity. For this reason,

all sterile products manufactured

by ETHICON are clearly labeled,

"DO NOT RESTERILIZE."

Manufacturers cannot be held

responsible for the quality,

effectiveness, or integrity of

suture materials resterilized in

the hospital, office, or by outside

vendors. Therefore, if customers

utilize the services of a sterilization

reprocessor for suture, ETHICON

will disclaim any responsibility for

sterilization and/or other product

failures resulting from the resteril-

ization process. The practice of

resterilization is not recommended,

except for ETHI-PACK* pre-cut

steel sutures and spools or cardreels

of nonabsorbable materials

supplied nonsterile.

* Trademark

CHAPTER 4 61

ANTICIPATING

SUTURE NEEDS

Today's healthcare environment

dictates that hospitals continue to

maintain quality standards while

lowering costs to remain financially

viable. Through total quality man-

agement initiatives, many hospitals

have identified material use as an

opportunity to lower cost. To

increase the efficiency of suture

utilization during a surgical

procedure, it is important to

determine and anticipate the

surgeon's needs more precisely.

For this reason, a file system of

preference cards for each surgeon

on staff is usually maintained in the

operating suite. The cards contain

such information as the surgeon's

"suture routine," suture materials,

sizes, needles, and/or product

code numbers customarily used in

specific procedures.

Becoming more aware of each

surgeon's routine through good

communication and regularly

updated preference cards can help

reduce preparation time, minimize

waste, and assure cost effectiveness.

Prior to dispensing suture packets,

the circulating nurse should have a

brief discussion with the surgeon to

ascertain whether a change in suture

routine is anticipated due to a

specific patient's needs.

While it is difficult to say precisely

how many suture packets are

enough, three major factors should

be considered in deciding how

many packets to open:

1. Fewer packets will be needed if

products with multiple strands of

suture material are used.

2. Opening sufficient suture packets

to prevent prolonging operative

time and causing surgeon

inconvenience.

3. Leftover suture on the surgical

field must be discarded.

Therefore, opening too many

suture packets should be

avoided to reduce waste and to

lower cost.

Although it is important to be

prepared to answer requests at a

moment's notice, it is not necessary

to overload the table with sutures.

The introduction of single-layer

peelable packaging, such as one-step

RELAY* packaging, helps encourage

less handling to access the suture,

enhancing quick delivery of suture

materials to the surgeon in the

sterile field. Unexpected suture

needs can also be obtained rapidly

from the storage racks.

STERILE TRANSFER OF

SUTURE PACKETS

At some point, suture packets

must cross the sterile barrier—the

invisible line of demarcation

between the sterile and the nonster-

ile. In all settings (e.g., operating

room, delivery room, emergency

department, or physician's office),

the individual who removes

the nonsterile overwrap must

remember these three points about

sterile transfer:

1. Outer surfaces of the overwrap

are not sterile and may be

handled with nonsterile hands.

2. The sterile inner packet or tray

must be transferred to the sterile

field without being touched or

contacting any nonsterile object

or surface.

3. Nonsterile hands over the sterile

field violate aseptic technique.

There are two methods commonly

used for achieving sterile transfer

of suture packets: handing-off the

sterile inner one-step RELAY tray

directly to the scrub person or

"flipping" the inner contents of the

primary packet onto the sterile field.

Regardless of the aseptic technique

performed, all items introduced

onto the sterile field should be

opened, dispensed, and transferred

by methods that maintain product

sterility and integrity. AORN

Guidelines recommend the

“hand-off” method, since items

tossed or flipped have a greater

potential to roll off the edge of the

sterile field, causing contamination

or other items to be displaced.

METHOD I: STERILE TRANSFER TO

THE SCRUB PERSON

Grasp the two flaps of the peelable

overwrap between the knuckles of

the thumbs and forefingers. With

a rolling-outward motion, peel

the flaps apart to approximately

one- third of the way down the

sealed edges. Keeping pressure

between the knuckles for control,

offer the sterile inner packet or

tray to the scrub person, who takes

it with a gloved hand or sterile

instrument. Care must be taken to

avoid contact with the nonsterile

overwrap as the packet or tray

is withdrawn.

This method must be used to

remove paper folder packets of sur-

gical steel and PROLENE* sutures

from long straight overwraps, and to

remove the organizer sleeves from

E-PACK* procedure kits. It should

also be used for transfer of flexible,

lightweight, transparent packets

containing microsurgery and oph-

thalmic products.

METHOD II: STERILE TRANSFER

TO THE STERILE FIELD

"Flipping" is a rapid and efficient

method of ejecting sterile product

from its overwrap onto the sterile

field without contacting the

unsterile outer packet or reaching

over the field. However, skill must

be acquired to ensure its effective

use. The circulating nurse must

stand near enough to the sterile

table to project the suture packet

or tray onto it, but not too close

as to risk contaminating the table

by touching it or extending

nonsterile hands over it. To

accomplish this, grasp the flaps

of the overwrap as described in

Method I and peel the flaps apart

with the same rolling-outward

motion. The sterile packet or tray

is projected onto the sterile table

as the overwrap is completely

peeled apart.

NOTE: DO NOT attempt to proj-

ect the inner folder of long straight

packets onto the sterile table.

Instead, present them to the scrub

person as outlined in Method I.

SUTURE PREPARATION

IN THE STERILE FIELD

Suture preparation may be more

confusing than virtually any other

aspect of case preparation.

Familiarity and understanding of

the sequence in which tissue layers

are handled by the surgeon will help

to eliminate this confusion. (See the

Suturing Section, Chapter 2.)

Once the suture packets are opened

and prepared according to the

surgeon's preference card, sutures

can be organized in the sequence in

which the surgeon will use them.

Ligatures (ties) are often used first

in subcutaneous tissue shortly after

the incision is made, unless ligating

clips or an electrosurgical cautery

device is used to coagulate severed

blood vessels.

After the ligating materials have

been prepared, the suturing

(sewing) materials can be prepared

in the same manner. Preparing large

amounts of suture material in

PACKAGING

STERILE

TRANSFER

TO THE

SCRUB

PERSON

FIGURE

3FIGURE

PREPARATION OF

STANDARD LENGTH

LIGATURE STRANDS

1. Prepare cut lengths of ligature

material, coil around fingers of left

hand, grasp free ends with right

hand, and unwind to full length.

2. Maintain loop in left hand and two

free ends in right hand. Gently pull

the strand to straighten.

3. To make 1/3lengths: Pass one free

end of strand from right to left hand.

Simultaneously catch a loop around

third finger of right hand. Make

strands equal in thirds and cut the

loops with scissors.

4. To make 1/4lengths: Pass both free

ends from right to left hand.

Simultaneously catch a double loop

around third finger of right hand.

Cut the loops.

5. Place packets or strands in suture

book (folded towel)—or under Mayo

tray—with ends extended far

enough to permit rapid extraction.

advance should be avoided. For

example, if the surgeon opens the

peritoneum (the lining of the

abdominal cavity) and discovers

disease or a condition that alters

plans for the surgical procedure

and anticipated use of sutures,

opened packets would be wasted.

At closure following abdominal

surgery, remembering the letters

PFS (peritoneum, fascia, skin) will

be helpful for organizing sutures.

By watching the progress of the

procedure closely, listening to

comments between the surgeon

and assistants, and evaluating

the situation; suture needs can

be anticipated. Free moments can

be used to prepare sufficient suture

material to stay one step ahead of

the surgeon. The goal should be to

have no unused strands at the end

of the procedure.

Ligature material which remains

toward the end of the procedure

may be the same material and size

specified by the surgeon for sutures

in the subcutaneous layer of wound

closure. In this case, the remaining

ligating material should be used

rather than opening an additional

suture packet.

If the surgeon requires "only

one more suture," and strands of

suitable material remain which

are shorter than those prepared

originally, do not be reluctant to

ask the surgeon if one of the

strands will serve the purpose

before opening a new packet.

Most surgeons are cooperative in

efforts to conserve valuable supplies.

SUTURE HANDLING

TECHNIQUE

During the first postoperative week,

the patient's wound has little or no

strength. The sutures or mechanical

devices must bear the responsibility

of holding the tissues together

during this period. They can only

perform this function reliably if the

quality and integrity of the wound

* Trademark

CHAPTER 4 63

FIGURE

PEPARATION

OF PRE-CUT

SUTURES

FOR TIES OR

LIGATURE

SUTURES

PREPARATION OF CONTINUOUS TIES

ON A LIGAPAK DISPENSING REEL

3. Hand reel to surgeon as

needed, being certain that

the end of the ligating

material is free to grasp.

4. Surgeon holds reel in

palm, feeds strand

beween fingers, and

places around tip of

hemostat.

1. Open the packet contain-

ing the appropriate

material on a reel. Transfer

the inner contents of the

primary packet to the

sterile field using aseptic

technique.

2. Extend the strand end

slightly for easy grasp-

ing. Place reel conviently

on the Mayo tray.

FIGURE

1. Remove one pre-cut length from nonabsorbable

suture at a time from the labrinth packet as it is

needed by the surgeon.

2. Extract pre-cut strands of SUTUPAK* sterile

absorbable or nonabsorbable suture. Straighten

surgical gut with a gentle pull. Place strands in

the suture book or under Mayo tray.

closure materials are preserved

during handling and preparation

prior to use. It is therefore essential

for everyone who will handle the

suture materials to understand

proper procedure to preserve

suture tensile strength.

In general, avoid crushing or

crimping sutures with surgical

instruments such as needleholders

and forceps, except as necessary

to grasp the free end of a suture

during an instrument tie. There

are also specific procedures to

follow to preserve suture tensile

strength which depend upon

whether the material is absorbable

or nonabsorbable. The following

summarizes the most important

points for each member of the

surgical team to remember and

observe in handling suture materials

and surgical needles.

FOR THE CIRCULATING NURSE

1. Consult the surgeon's preference

card for suture routine.

2. Check the label on the dispenser

box for type and size of suture

material and needle(s). Note the

number of strands per packet.

Fewer packets will be needed if

multistrand or CONTROL

RELEASE* sutures are used.

3. Estimate suture requirements

accurately and dispense only the

type and number of sutures

required for the procedure.

4. Read the label on the primary

packet or overwrap before using

to avoid opening the wrong

packet.

5. Use aseptic technique when

peeling the overwrap. Transfer

the inner contents of the primary

packet to the sterile field by

offering it to the scrub person or

by projecting (flipping) it onto

the sterile table, avoiding

contamination.

6. To open long straight packets,

peel overwrap down 6 to 8 inch-

es and present to the scrub

person. Do not attempt to

project the inner folder of long

straight packets onto the

sterile table.

7. Maintain an adequate supply of

the most frequently used sutures

readily accessible.

8. Rotate stock using the "first-in,

first-out" rule to avoid expira-

tion of dated products and keep

inventories current.

9. Suture packets identify the

number of needles per packet to

simplify needle counts. Retain

this information during the

procedure and/or until final

needle counts are completed.

10. Count needles with the scrub

person, per hospital procedure.

FOR THE SCRUB PERSON

1. If appropriate, remove the inner

one-step RELAY* tray or folder

containing suture materials from

the primary packet being offered

from the circulating nurse.

2. Hold the one-step RELAY tray or

folder in gloved hand and arm

the needle using the "no-touch"

technique. Gently dispense the

suture.

3. Leave pre-cut suture lengths in

labyrinth packet on the Mayo

tray. Strands can then be

removed one at a time as needed.

4. Surgical gut and collagen sutures

for ophthalmic use must first be

rinsed briefly in tepid water to

avoid irritating sensitive tissues.

PACKAGING

ETHICON

MODULAR

STORAGE

RACKS

FIGURE

1. With a rolling-outward motion,

peel the flaps apart to approxi-

mately ont-third the way down

the sealed edges. Keeping pres-

sure beween the knuckles for

control, offer the sterile inner

RELAY tray to the scrub person.

2. Clamp the needleholder approx-

imately one-third to one-half of

the distance from the swage

area to the needle point. Do not

clamp the swaged area. Gently

pull the suture to the right in a

straight line.

3. Additional suture straightening

should be minimal. If the strand

must be straightened, hold the

armed needleholder and gently

pull the strand making certain

not to disarm the needle from

the suture.

If the surgeon prefers to use

sutures wet, dip only momentar-

ily. Do not soak. Silk sutures

should be used dry.

5. Do not pull or stretch surgical

gut or collagen. Excessive

handling with rubber gloves can

weaken and fray these sutures.

6. Count needles with the

circulating nurse, per hospital

procedure.

7. Hold single strands taut for

surgeon to grasp and use as a

freehand tie.

8. Do not pull on needles to

straighten as this may cause

premature separation of

CONTROL RELEASE needle

suture.

9. Always protect the needle to

prevent dulling points and

cutting edges. Clamp the needle-

holder forward of the swaged

area, approximately one-third to

one-half the distance from the

swage to the point.

10. Microsurgery sutures and

needles are so fine that they may

be difficult to see and handle.

They are packaged with the

needles parked in foam to

protect delicate points and

edges. The needles may be

armed directly from the foam

needle park. If the microsurgeon

prefers to arm the needle, the

removable orange colored tab

may be used to transport the

needle into the microscopic

field.

11. Handle all sutures and needles

as little as possible. Sutures

should be handled without using

instruments unless absolutely

necessary. Clamping instruments

on strands can crush, cut, and

weaken them.

12. Cut sutures only with suture

scissors. Cut surgical steel with

wire scissors.

13. When requesting additional

suture material from the

circulating nurse, estimate usage

as accurately as possible to

avoid waste.

FOR THE SURGEON

1. Avoid damage to the suture

strand when handling. This is

particularly critical when

handling fine sizes of monofila-

ment material. Touch strands

only with gloved hand or closed

blunt instrument. Do not crush

or crimp sutures with instru-

ments, such as needleholders or

forceps, except when grasping the

free end of the suture during an

instrument tie.

2. Clamp a rubber shod hemostat

onto the suture to anchor the

free needle on a double-armed

strand until the second needle is

used. Never clamp the portion of

suture that will be incorporated

into the closure or the knot.

3. Use a closed needleholder or

nerve hook to distribute tension

along a continuous suture line.

Be careful not to damage the

suture.

4. Use knot tying techniques that

are appropriate for the suture

material being used.

* Trademark

CHAPTER 4 65

PACKAGING

PRESERVATION

OF TENSILE

STRENGTH:

ABSORBABLE

SUTURES

TABLE

1. Protect absorbable sutures from heat and moisture.

a. Store suture packets at room temperature. Avoid prolonged storage in hot

areas such as near steam pipes or sterilizers.

b. Do not soak absorbable sutures. Also avoid prolonged placement of sutures

in a moist suture book.

c. Surgical gut can be dipped momentarily in tepid (room temperature) water

or saline to restore pliability if strands dry out before use. Surgical gut or

collagen for use in ophthalmic surgery should be rinsed briefly in tepid

water before use, as they are packed in a solution usually consisting of

alcohol and water to maintain pliability.

d. Synthetic absorbable sutures must be kept dry. Use strands directly from

packet when possible. Store sutures in a dry suture book if necessary.

2. Straighten strands with a gently, steady, even pull. Jerking and tugging can

weaken sutures.

3. Do not "test" suture strength.

4. Do not resterilize.

PRESERVATION

OF TENSILE

STRENGTH:

NONABSORBABLE

SUTURES

TABLE

SILK – Store strands in a dry towel. Dry strands are stronger than wet strands. Wet silk

loses up to 20% in strength. Handle carefully to avoid abrasion, kinking, nicking, or

instrument damage. Do not resterilize.

SURGICAL STAINLESS STEEL – Handle carefully to avoid kinks and bends. Repeated

bending can cause breakage. Stainless steel suture can be steam sterilized without any

loss of tensile strength. However, DO NOT steam sterilize on spool or in contact with

wood. Lignin is leached from wood subjected to high temperature and may cling to

suture material. Handle carefully to avoid abrasion, kinking, nicking, or instrument dam-

age.

POLYESTER FIBER – Unaffected by moisture. May be used wet or dry. Handle carefully

to avoid abrasion, kinking, nicking, or instrument damage. Do not resterilize.

NYLON – Straighten kinks or bends by "caressing" strand between gloved fingers a few

times. Handle carefully to avoid abrasion, kinking, nicking, or instrument damage.

POLYPROPYLENE – Unaffected by moisture. May be used wet or dry. Straighten

strands with a gentle, steady, even pull. Handle with special care to avoid abrasion,

kinking, nicking, or instrument damage. Do not resterilize.

TOPICAL SKIN ADHESIVES

CHAPTER 5

Low tension wounds (those where

the skin edges lie close together

without significant tension) can be

closed by gluing the skin edges

together with a skin adhesive.

Butylcyanoacrylate adhesives have

been available in Europe, Israel, and

Canada for decades.1They have

been used successfully for the

closure of traumatic lacerations and

surgical incisions. Application of

butylcyanoacrylate was found to be

more rapid and cost effective than

suturing, but only recently has it

been evaluated in well-designed

clinical trials for wound closure.1

The most significant advance in

the field of topical skin adhesives

has been the development of

2-octyl cyanoacrylate, marketed as

DERMABOND* Topical Skin

Adhesive by ETHICON Products.

This topical skin adhesive forms a

transparent and flexible bond,

unlike the opaque and brittle bond

formed by butylcyanoacrylate

adhesives. The flexibility of

octyl cyanoacrylate allows it to be

applied over nonuniform surfaces.

This flexibility also combats the

topical shear forces exerted on the

adhesive, reducing the risk of

premature sloughing and wound

dehiscence. Additionally, octyl

cyanoacrylate adhesive has been

found to have three times the

breaking strength of butylcyano-

acrylate, so it can be used on longer

incisions and lacerations.1

DERMABOND*

TOPICAL SKIN ADHESIVE

(2-OCTYL CYANOACRYLATE)

is a sterile, liquid topical adhesive

designed to repair low-tension

lacerations and to close wounds

and surgical incisions. It utilizes the

moisture on the skin's surface to

form a strong, flexible bond and can

be used in many instances where

sutures, staples or skin strips

have been traditionally used.

DERMABOND adhesive is ideally

suited for wounds on the face, torso

and limbs and offers cosmetic

advantages over other forms of

skin closure. It can be used in

conjunction with, but not in place

of, deep dermal sutures.

Approved by the FDA in 1998,

DERMABOND adhesive has

been used extensively by health

professionals in the fields of trauma,

plastic and other surgeries,

emergency medicine, and pediatrics.

Since its approval, DERMABOND

adhesive has proven useful in

closing surgical incisions where

suture removal can cause significant

discomfort. The adhesive does not

produce suture or "track" marks

along the healed incision and unlike

stitches, a patient can shower right

away without fear of compromising

the incision.

STRENGTH AND SECURITY

In less than three minutes,

DERMABOND adhesive provides

the strength of healed tissue at

7 days after traditional closure with

sutures.2A strong, flexible

3-dimensional bond makes it

suitable for use in closing easily

approximated incisions

(example—deep, short, long).3

SEALS OUT BACTERIA

DERMABOND adhesive is the first

wound-closure technology approved to

protect wounds & incisions from

common microbes. For trauma and

post-surgical patients, infections are

often the most common, and in

some cases, the most serious

complications. DERMABOND

adhesive helps protect against the

penetration of bacteria commonly

associated with surgical site

infections.2In vitro studies

demonstrated that DERMABOND

adhesive provides 99% efficacy in

protection against Staphylococcus

epidermidis, Staphylococcus aureus,

Escherichia coli, Pseudomonas

aeruginosa and Enterococcus faecium.2

DERMABOND adhesive acts as a

barrier to microbial penetration as

long as the adhesive film remains

intact.

PROMOTES A MOIST,

WOUND-HEALING ENVIRONMENT

DERMABOND adhesive creates a

protective seal that helps the wound

stay moist.2Maintaining a moist

wound-healing environment around

the wound has been shown to speed

the rate of epithelialization.4As the

wound heals (generally between 5 to

10 days), DERMABOND adhesive

will gradually peel off.2

PROVIDES EXCELLENT

COSMETIC RESULTS

In a prospective, randomized,

controlled, unmasked study of 818

patients, DERMABOND adhesive

provided cosmesis equivalent to that

of sutures. At 3 months, it produced

optimal cosmesis in 80% of

patients, using the Modified

Hollander Cosmesis Scale.2

TOPICAL SKIN ADHESIVES

MORE COST EFFECTIVE

THAN SUTURES

In most cases, DERMABOND

adhesive allows for significantly

faster closure than sutures.3,5,6

DERMABOND adhesive applica-

tion requires fewer surgical supplies,

reduced equipment needs, and

eliminates the need for suture

removal.6,7

DERMABOND adhesive is also

more convenient and comfortable

for the patient because it often does

not require anesthetic, is gentler to

the skin than sutures or staples, and

does not require suture removal.

DERMABOND adhesive also

reduces the risk of needle stick

injury to both physician and

patient.

INDICATIONS AND

CONTRAINDICATIONS

DERMABOND adhesive is intended

for topical application only to hold

closed easily approximated skin edges

of wounds from surgical incisions,

including punctures from minimally

invasive surgery, and simple,

thoroughly cleansed, trauma-induced

lacerations. DERMABOND adhesive

may be used in conjunction with, but

not in place of, subcuticular sutures.

Topical skin adhesives are not

appropriate for closing wounds that

are subject to significant static or

dynamic tensions (e.g., over joints)

unless deep sutures, immobilization,

or both are also used.

DERMABOND adhesive is contra-

indicated for use on any wounds

with evidence of active infection or

gangrene. It should also not be used

on mucosal surfaces or across

mucocutaneous junctions (e.g., lips,

oral cavity), or on skin that is

regularly exposed to body fluids or

with dense hair (e.g., scalp).

DERMABOND adhesive should

not be used on patients with a

known hypersensitivity to

cyanoacrylate or formaldehyde.

APPLICATION

Mastery of tissue adhesive use

is generally quite rapid. Proper

wound selection, evaluation and

preparation before closure is

important. Wounds must be

thoroughly cleansed and debrided

in accordance with standard practice

before using adhesives. The wound

edges must be tightly apposed so

that the adhesive is not placed

into the wound. Patient positioning

is also important to reduce runoff

of tissue adhesive. The patient

should be positioned so that the

wound surface is parallel to the

floor, taking special care that

any runoff does not flow in the

direction of vital structures such

as the eye.

* Trademark

CHAPTER 5 69

TOPICAL SKIN ADHESIVES

DERMABOND Topical Skin Adhesive (2-octyl

cyanoacrylate) is a sterile, liquid skin adhesive that

holds wound edges together. The film will usually

remain in place for 5 to 10 days, then naturally falls

off the skin.

The following provides instructions for proper care of

the wound while it is healing:

CHECK WOUND APPEARANCE

Some swelling, redness and pain are common with all

wounds and normally will go away as the wound

heals. If swelling, redness, or pain increases or if the

wound feels warm to the touch, instruct patients to

contact a doctor. A doctor should also be contacted if

the wound edges reopen or separate.

REPLACE BANDAGES

If the wound is bandaged, the patient should be

instructed to keep the bandage dry. The dressing

should be replaced daily until the adhesive film has

fallen off or if the bandage should become wet, unless

otherwise instructed by the physician.

When changing the dressing, tape should not be

placed directly over the DERMABOND adhesive

film, because removing the tape later may also

remove the film.

AVOID TOPICAL MEDICATIONS

Instruct patients not to apply liquid or ointment

medications or any other product to the wound while

the DERMABOND adhesive film is in place. These

may loosen the film before the wound is healed.

KEEP WOUND DRY AND PROTECTED

Patients may occasionally and briefly wet the wound

in the shower or bath. They should not soak or scrub

the wound. They should not swim and should

avoid periods of heavy perspiration until the

DERMABOND adhesive has naturally fallen off.

After showering or bathing, the patient should blot

the wound dry with a soft towel. If a protective

dressing is being used, a fresh, dry bandage should

be applied, being sure to keep the tape off the

DERMABOND adhesive film.

Additional instructions for patients include:

• Apply a clean, dry bandage over the wound if

necessary to protect it.

• Protect the wound from injury until the skin has

had sufficient time to heal.

• Do not scratch, rub or pick at the DERMABOND

adhesive film. This may loosen the film before the

wound is healed.

• Protect the wound from prolonged exposure to

sunlight or tanning lamps while the film is in place.

HOW TO CARE FOR A WOUND

AFTER IT’S TREATED WITH

DERMABOND* TOPICAL SKIN ADHESIVE TABLE

* Trademark

CHAPTER 5 71

REFERENCES

1. Singer, Adam J., Lacerations and

Acute Wounds, An Evidence-

Based Guide; F.A. Davis

Company, 2003, p. 83-97.

2. Data on file, ETHICON, INC.

3. Quinn, G Wells, T Sutcliffe,

et al. A Randomized Trial

Comparing Octyl Cyanoacrylate

Tissue Adhesive and Sutures in

the Management of Lacerations.

JAMA 1997;227(19):1527-1530.

4. Singer AJ, Hollander JE, Quinn

JV. Evaluation and management

of traumatic lacerations.

N Engl J Med.

1997;337(16):1142-1148.

5. Bruns TB, Robinson BS, Smith

RJ et al. A new tissue adhesive

for laceration repair in children.

J Pediatr. 1998;132:1067-1070.

6. Theodore N, et al. The

Economics of DERMABOND

in Neurosurgical Wound

Closure. Phoenix, Ariz:

Neuroscience Publications,

Barrow Neurological Institute.

March 2001:2-10.

7. Osmond MH, Klassen TP,

Quinn JV. Economic comparison

of a tissue adhesive and suturing

in the repair of pediatric facial

lacerations. J Pediatr. 1995;

126:892-895.

OTHER SURGICAL

PRODUCTS

CHAPTER 6

ADHESIVE TAPES

There are many surgical products

available which may be used during

wound closure and other operative

procedures which involve suturing.

Each of these products has specific

indications for use. Adhesive tapes

are used for approximating the

edges of lacerations, skin closures,

repair and/or support in selected

operative procedures.

Adhesive tapes are associated with

minimal tissue reactivity and yield

the lowest rate of infection, but

they tend to slough off in the

presence of tension or moisture.1

Advantages of adhesive tapes

include rapid application, little or

no patient discomfort, low cost, and

no risk of needle-stick injuries. They

are associated with minimal tissue

reactivity and yield the lowest infec-

tion rates of any wound closure

method. They may be left on for

long periods without resulting in

suture hatch marks.

Surgical tapes are not commonly

recommended as the sole modality

for primary wound closure due

to the high probability of

dislodgement and dehiscence,

the inability to use them in

hair-bearing areas, and the need

to keep them dry. Their use is

typically reserved for linear lacera-

tions under minimal tension.

Furthermore, surgical tapes do not

approximate deeper tissues and do

not control bleeding.

INDICATIONS AND USAGE

Skin closure tapes are an effective

alternative to sutures or staples

when tensile strength and resistance

to infection are not critical factors.

Skin closure tapes can also be

used to complement suture or

staple closures. Stress is applied

uniformly to the collagen fibers,

aiding in rapid fiber orientation

and increased tensile strength.

APPLICATION

Skin closure tapes may be applied to

the skin over a subcuticular closure

in lieu of skin sutures or used as a

primary closure in conjunction with

sutures in an alternating pattern.

The tape is placed on one side of

the wound at its midpoint, while

grasping it with forceps in the

dominant hand. The opposite

wound edge is then gently apposed

by pushing with a finger of the

nondominant hand. The wound

edges should not be apposed by

pulling on the free end of the

tape. This can result in unequal

distribution of skin tensions,

causing erythema or even blistering

of the skin. Additional strips are

then placed perpendicular to the

laceration on either side of the

original tape, bisecting the

remaining open wound with each

strip until the space between tapes

is no more than about 2 to 5 mm.

Additional strips are then placed

over the ends of the other strips,

parallel to the laceration.

Skin closure tapes may also be used

as a replacement for sutures or

staples which are removed on the

first to fourth postoperative day.

Effective skin closure tapes provide

good porosity in terms of air inflow

to the wound and water vapor

transmission escaping from the

wound during the healing process.

AFTER CARE AND REMOVAL

Adhesive tapes should be left in

place as long as possible, at least as

long as sutures would be left before

removal. To prevent the tapes from

prematurely coming loose, patients

must be warned to keep them as

dry as possible and not to cover

them with ointments. Showering

is permitted and during the

first week many surgeons

recommend that patients cover

their wounds and tape with a

nonadherent dressing.

OTHER SURGICAL PRODUCTS

ADVANTAGES

AND

DISADVANTAGES

OF ADHESIVE

TAPES FOR

SKIN CLOSURE1

TABLE

ADVANTAGES DISADVANTAGES

• Rapid and simple

closure

• Least damage to

host defenses

• No risk of needle-stick

injuries

• Do not cause tissue

ischemia or necrosis

• Relatively poor

adherence

• Easily removed by

patient

• Must be kept dry

• Cannot be used over

oily or hair-bearing

areas

* Trademark

SKIN CLOSURE TAPES

PROXI-STRIP* skin closures are

long, narrow, sterile strips of tape

with an adhesive backing. They are

used for approximating the edges of

lacerations and for closing skin fol-

lowing many operative procedures.

PROXI-STRIP skin closures have a

high degree of porosity to allow the

wound to breathe, but have suffi-

cient adhesive strength to negate the

use of adjunct applications, such as

tincture of benzoin. Their antistatic

properties minimize the tendency of

the tape strips to curl up.

POLYESTER FIBER STRIP

MERSILENE* polyester fiber strip

is comprised of a double thickness

of MERSILENE polyester fiber

that is 5mm wide. The strips are

available with and without

needles and may be used instead

of large-sized suture for ligation,

repair, and/or support in selected

operative procedures.

Incompetence of the cervix is a

condition characterized by the

habitual premature, spontaneous

abortion of the fetus. A ligature is

placed around the cervix in a

collar-like fashion, drawn tight,

and either sutured together or tied

closed. A MERSILENE strip is

then woven carefully with a swage

blunt needle in and out of the

mucosa. When placed properly,

the flatness of the ligature will not

cut or damage the wall of the cervix.

MERSILENE strip attached to

a heavy reverse cutting needle

provides a wide band of strong

material for orthopaedic procedures

such as rotator cuff repair and

support. The blunt needles used for

the incompetent cervix ligation may

also be used for this purpose.

UMBILICAL TAPE

Umbilical tape is a white woven

cotton ligature, 1/8or 1/4inch

(0.32 or 0.64cm) wide that is strong

enough to tie off the umbilical cord

of the newborn infant. While this

was its original use, umbilical

tape is also used in pediatric and

cardiovascular procedures to

suspend small structures and vessels

during the operation, but is not left

in place.

Umbilical tape easily absorbs

blood when used in an area of

gross bleeding. The 1/8-inch

(0.32cm) tape is available with a

radiopaque thread woven into the

length of the fabric to facilitate

x-ray identification.

SURGICAL

STAPLES

The staple closure is mainly used for

large wounds that are not on the

face. Stapling is especially useful

for closing scalp wounds. Staples

are also used for linear lacerations

of the torso and extremities,

especially if they are relatively long.

Many surgeons routinely use skin

staples for closure of standard

abdominal, thorax and extremity

incisions. Advantages of stapling

include ease of use, rapidity, cost

effectiveness, and minimal damage

to host defenses.1

CHAPTER 6 75

SKIN

CLOSURE

TAPES

FIGURE

1. Using sterile technique,

remove card from sleeve and

tear off tab.

2. Peel off tapes as needed in

diagonal direction.

3. Apply tapes at 1/8-inch

intervals as needed to

complete wound apposition.

Make sure the skin surface is

dry before applying each tape.

4. When healing is judged to be

adequate, remove each tape

by peeling off each half from

the outside toward the wound

margin. Then, gently lift

the tape away from the

wound surface.

A variety of stapling devices is

available for wound closure. With

all devices, the staple creates an

incomplete rectangle: the legs of the

staple extend into the skin, and the

cross-limb lies on the skin surface

across the wound. Each device may

differ in its handling characteristics,

visual access, the angle at which

the staples enter tissues, the ease

of position and the pre-cocking

mechanism. Optimal visibility as

the staple is placed in the skin is

important, as is the angle at which

the staple enters the skin because

insertion of the staple perpendicular

to the surface of the skin results in

deep penetration that increases the

likelihood of tissue strangulation

and permanent cross-hatching of

the wound. The ability of the

staple end to swivel allows the head

to be adjusted for use in deep

recesses. Finally, the presence of a

pre-cocking mechanism allows the

practitioner to maintain constant

control while stapling the skin.1

Before inserting staples, it is impor-

tant to line up the wound edges

with the centerline indicator on the

head of the stapler to make sure that

the legs of the staple will enter the

skin at equal distances on either side

of the wound edge. Each edge is

typically picked up with a forceps,

everted and precisely lined up.

The surgeon then places the staples

to close the wound while the first

assistant advances the forceps,

everting the edges of the wound.

This technique is continued until

the entire wound is everted and

closed with staples.2

INDICATIONS AND USAGE

Wound closure with staples is

indicated for scalp lacerations

that do not require extensive

hemostasis and do not involve tears

in the underlying frontooccipital

aponeurosis (galea). They are

also indicated for linear nonfacial

lacerations caused by shear forces

(e.g., sharp objects).

AFTERCARE AND REMOVAL

Skin staples should be removed

at the same time that sutures

would be removed, based on wound

location and tension. For scalp

wounds, staples should be removed

on day 7 after insertion. For trunk

and extremity wounds, staples

should be removed between days 7

and 14. Wounds closed with staples

may be covered with a topical

antibiotic cream or ointment.

Patients may bathe or shower

the next day, but should avoid

prolonged exposure to moisture.

When used on the scalp, patients

should be very careful about

combing or brushing their hair.

A specially designed, single-handed,

disposable staple remover should be

used to remove the staples by a

health care provider.

PROXIMATE* Skin Staplers

PROXIMATE Skin Staplers place

single staples to close surgical

incisions. Staples are made of

lubricant-coated stainless steel;

OTHER SURGICAL PRODUCTS

PROXIMATE*

SKIN STAPLERS TABLE

PROXIMATE* RH Skin Staplers

(Rotating Head Skin Staplers)

Rectangular

staples

Head rotates 360°;

cartridge is clear

Staples are coated

with lubricant

Pistol-grip handle

PROXIMATE* PX Skin Staplers PROXIMATE* PLUS MD Skin Staplers

(Multi-Directional Skin Staplers)

Features Benefits Features Benefits Features Benefits

Minimizes staple

rotation

Improves visibility

and access

Easy staple

extraction

Comfortable

to use

Ergonomic pistol

grip

Positive ratchet

mechanism

Staples are coated

with lubricant

Intuitive and

comfortable to use

Easy staple

placement

Easy staple

extraction

Improved kick-off

spring design

Ergonomic design

Alignment indicator

Staples are coated

with lubricant

Multi-direction

release

Comfortable for

smaller hands

Improves visibility

Easy staple extraction

* Trademark

the staplers are not reloadable.

Ethicon Endo-Surgery makes

three different skins staplers to

meet surgeons’ needs.

PROXIMATE* RH is a full-feature

skin stapler with a 360° rotating

head assembly.

PROXIMATE RH has improved

visibility over existing fixed-head

skin stapling products along with

a ratchet mechanism for easier

staple placement.

PROXIMATE* PX skin stapler

provides many of the same features

as the PROXIMATE RH skin

stapler but in a fixed-head format.

PROXIMATE* PLUS MD is a

high-value, low-cost skin stapler

that permits multi-directional

release in an ergonomic design.

LOOPED SUTURE

ETHICON looped sutures range in

length up to a 60-inch strand with

both ends swaged to a single taper

point needle. Available in various

materials and suture sizes, they

provide a simple, reliable technique

for continuous closure of the fascia

of the abdominal wall. The needle

of the looped suture is passed

through the fascia from inside out

at one end of the incision, then

through the opposite wound edge

from outside in, and then passed

through the loop. The locking stitch

lies beneath the wound edge. The

double strand is run over and over

to the other end of the incision.

The final stitch is completed by

passing the needle from the outside

in, cutting one strand, and passing

the needle through the opposite

wound edge from the outside in.

The needle is then cut off and

the loose suture ends tied together,

leaving the knot inverted under

the fascia.

RETENTION

SUTURE DEVICES

Retention sutures, if not placed

carefully without excessive tension,

can cut the skin. Devices such as

bolsters and bridges are used to

prevent such complications and

eliminate pressure. However, care

should also be taken in the use of

these devices.

Retention suture bolsters are sterile

21/2-inch (6cm) lengths of 3/16-inch

(0.48cm) diameter surgical latex

tubing with a 1/32-inch (0.08cm)

wall. The suture is threaded through

the bolster and tied. Sutures

sheathed in this manner can cause

an inflammatory response with

reaction both at the site of the

suture exit from the skin and along

CHAPTER 6 77

ADJUSTMENT

RETENTION

SUTURE

BRIDGE

FIGURE

1. Pass the retention suture

through appropriate holes in

the bridge.

2. Place the suture with tension

over the slit in the capstan,

and tie.

3. To adjust tension, lift capstan. 4. Rotate capstan until desired

tension is attained.

5. To lock, press capstan down

into bridge.

the entire length of the suture itself.

Also, the skin may become necrotic

beneath the bolsters if the sutures

are too tight. This invariably occurs

if the sutures are tightly tied at the

time of the operation, as subsequent

tissue edema ensues.

The retention suture bridge is a

strong plastic truss that can be

adjusted to relieve the pressure of

the retention suture on the skin

during, and subsequent to, initial

suture placement. After the desired

number of sutures is placed in the

wound, a sterile bridge is positioned

over each retention suture. Each

side of the bridge has six holes

spaced 1/4inch (0.64cm) apart to

accommodate many patient sizes.

The ends of the sutures are passed

through the appropriate holes and

tied loosely over the bridge. The

suture strand is then slipped into

the capstan located in the middle

of the bridge, and the capstan is

rotated to apply the desired

tension before locking into place.

The bridge permits easy tension

readjustment by raising and rotating

the capstan to compensate for

postoperative wound edema, and

again when the edema subsides.

The suture remains elevated away

from the skin while the bridge has

contact along its entire 4 3/8-inch

(11cm) length. Pressure is evenly

distributed over the area, and the

transparent bridge facilitates com-

plete visualization of the wound.

REFERENCES

1. Singer, Adam J., Lacerations and

Acute Wounds, An Evidence-Based

Guide; F.A. Davis Company,

2. Skerris, David A., Mayo Clinic

Basic Surgery Skills, Mayo Clinic

Scientific Press, 1999; p.117.

OTHER SURGICAL PRODUCTS

PRODUCT TERMS

AND TRADEMARKS

CHAPTER 7

ABSORBABLE SUTURE

Sutures which are broken down and

eventually absorbed by either

hydrolysis (synthetic absorbable

sutures) or digestion by lysosomal

enzymes elicited by white blood

cells (surgical gut and collagen).

APPROXIMATE

Bring together sides or edges.

ATRALOC*

SURGICAL NEEDLES

ETHICON* trademark for eyeless

needles permanently attached

(swaged) to suture strands.

B & S GAUGE

Brown and Sharpe gauge commonly

used in hospitals to identify wire

diameter. ETHICON stainless steel

suture products are labeled with

both B & S gauge and U.S.P. size.

BURIED SUTURE

Any stitch made and tied so that

it remains completely under

the surface.

CALCIFIED CORONARY

NEEDLE (CC)

A TAPERCUT* surgical needle

with a 1/16" cutting tip and slim

taper ratio for significant ease of

penetration when suturing tough

valve cuffs or atherosclerotic vessels.

CARDIOVASCULAR SUTURES

Swaged sutures designed to meet the

specific needs of heart and blood

vessel surgery.

CATGUT

Outmoded term for surgical gut

suture.

CHROMIC SURGICAL GUT

Gut suture which has been treated

by chromium salts to resist

digestion by lysosomal enzymes.

CHROMICIZING

ETHICON process for producing

chromic gut. Each ribbon of

surgical gut is bathed in a

chromium salt solution before

spinning into strands to provide

uniform controlled absorption.

COATED VICRYL*

(POLYGLACTIN 910) SUTURE

ETHICON trademark for synthetic

absorbable suture extruded from a

copolymer of glycolide and lactide

and coated with a mixture of

polyglactin 370 and calcium

stearate.

COATED VICRYL* RAPIDE

(POLYGLACTIN 910) SUTURE

ETHICON trademark for braided,

rapidly absorbing synthetic suture

extruded from a copolymer of

glycolide and lactide and coated

with a mixture of polyglactin 370

and calcium stearate.

COBALT 60

Source of irradiation used by

ETHICON, INC., to sterilize some

suture materials. Also used in

hospitals to treat some cancer

patients.

COMPOUND CURVED NEEDLE

Needle that incorporates two

curvatures in one needle: a tight

curve at the tip, and a more gradual

curve through the body. Used for

precise positioning of sutures for

comeal/scleral closure and for

skin suturing.

CONTAMINATE

To cause a sterile object or surface

to become unsterile.

CONTINUOUS SUTURE

TECHNIQUE

Single suture strand passed back and

forth between the two edges of the

wound to close a tissue layer; tied

only at each end of the suture line.

CONTROL RELEASE* NEEDLE

ETHICON trademark for swaging

method which permits fast and

controlled separation of the needle

from the suture material.

CONVENTIONAL

CUTTING NEEDLE

Needle with triangular point and

cutting edge along inner curvature

of needle body.

CORNEAL BEADED

RETRACTION SUTURE

Swaged suture strand with a small

bead of epoxy used to elevate cornea

for placement of intraocular lens.

CS ULTIMA*

OPHTHALMIC NEEDLE (CS)

ETHICON trademark for needle

with reduced side edge angles

providing excellent penetration

necessary for ophthalmic surgery.

Design facilitates knot rotation

during surgery.

CUTICULAR SUTURES

Sutures designed for skin closure.

DEAD SPACE

Pockets left in a tissue layer when

tissues are not in close

approximation.

PRODUCT TERMS AND TRADEMARKS

DECONTAMINATION

Process used to destroy

microorganisms known or thought

to be present on a surface or object.

DEHISCENCE

Total or partial separation of

wound edges.

DERMABOND*

TOPICAL SKIN ADHESIVE

(2-OCTYL CYANOACRYLATE)

ETHICON trademark for sterile,

liquid topical skin adhesive for

approximation of wound edges of

trauma-induced lacerations or

surgical incisions.

DISPENSER BOXES

Gravity-fed vertical or horizontal

boxes that readily dispense wound

closure products. Labels on boxes

include product information.

DOUBLE-ARMED SUTURE

Suture strand with a needle swaged

at each end.

EASY ACCESS* PACKAGING

ETHICON trademark for patented

delivery system that presents the

needle in position for immediate

arming in the needleholder as soon

as the primary packet is opened.

E-PACK* PROCEDURE KIT

ETHICON trademark for single

overwrapped organizer tray

containing multiple ETHICON

suture products. Each E-PACK kit

may be customized with choice of

sutures for specific procedures or

surgeon preferences.

ETHALLOY* NEEDLE ALLOY

ETHICON trademark for exclusive

patented stainless steel alloy that is

40 percent stronger than needles

made of 300 Series stainless

steel. Provides improved tissue

penetration, smoother needle-to-

suture transition, and better flow

through tissue.

ETHIBOND* EXCEL

POLYESTER SUTURE

ETHICON trademark for braided

polyester suture coated with

polybutilate coating.

ETHIGUARD* BLUNT

POINT NEEDLE

ETHICON trademark for specially

designed needle which has a

rounded tip.

ETHILON* NYLON SUTURE

ETHICON trademark for sutures

made of monofilament nylon.

ETHI-PACK* PRE-CUT SUTURE

ETHICON trademark for

pre-cut strands of nonabsorbable

sutures without needles, sterile

and nonsterile.

ETHYLENE OXIDE GAS

Chemical agent used to sterilize

some suture materials.

EVISCERATION

Protrusion of bowel through

separated edges of abdominal

wound closure.

EXPIRATION DATE

Date on a suture product

representing the time through

which satisfactory stability studies

have been carried out.

EXTRUSION OF KNOTS, KNOT

EXTRUSION, OR "SPITTING"

Attempt by the human body to rid

itself of nonabsorbable sutures or

absorbable sutures which are not

completely absorbed (“foreign

bodies”). Suture knots encapsulated

by cells may work their way to the

skin surface months or even years

after surgery.

FASCIA

Areolar tissue layers under the skin

(superficial fascia) or fibrous tissue

between muscles and forming the

sheaths of muscles or investing

other structures such as nerves or

blood vessels (deep fascia).

FDA

Abbreviation for federal Food and

Drug Administration.

GASTROINTESTINAL SUTURES

Sutures designed for use in

anastomosis of bowel and stomach

surgery.

GAUGE

Term used to express diameter of

suture strand.

GENERAL CLOSURE SUTURES

Sutures used in closing fascia,

particularly in the abdominal wall.

Also for hernia repair and other

fascial defects.

* Trademark

CHAPTER 7 81

GENTLE BEND* PACKAGE

ETHICON trademark for

packaging designed to deliver

monofilament PROLENE*

polypropylene suture to the surgical

field in a straight usable form.

HEMO-SEAL* NEEDLE SUTURE

ETHICON trademark for a

needle/suture combination

manufactured using a swaging

method that provides a smoother

needle-to-suture transition.

Beneficial in reducing leakage

from the suture line, especially in

cardiovascular procedures.

HYDROLYSIS

Chemical process whereby a

compound or polymer reacts with

water to cause an alteration or

breakdown of the molecular

structure. Synthetic absorbable

sutures are degraded in vivo by

this mechanism.

INFECTION

Invasion of body tissue by a

pathogen.

INTERRUPTED SUTURE

TECHNIQUE

Single stitches separately placed,

tied, and cut.

KEITH NEEDLE (KS)

Straight needle with cutting edges,

used primarily for abdominal skin

closure. Named for a Scottish

surgeon, Dr. Thomas Keith, who

made the needle popular.

KINK

Undesirable deformation of a

strand, such as a sharp bend in wire.

LABYRINTH* PACKAGE

ETHICON trademark for unique

package that dispenses straight,

kink-free, pre-cut nonabsorbable

sutures.

LIGAPAK* DISPENSING REEL

ETHICON trademark for disc-like

plastic reel that contains and

dispenses suture for ligation.

LIGAPAK LIGATURE

ETHICON trademark for a length

of suture material wound on a reel,

primarily used for ligating.

LIGATING REEL

Tube, plastic disc, or other device

from which continuous ligating

material is unwound as blood vessels

are tied.

LIGATURE

Strand of material used to tie off a

blood vessel.

LOOPED SUTURE

Single strand of suture material

with both ends swaged onto a

single needle.

MERSILENE* POLYESTER

FIBER MESH

ETHICON trademark for machine-

knitted fabric which is used in

hernia repair and other fascial

deficiencies that require addition of

a reinforcing or bridging material.

MERSILENE* POLYESTER FIBER

STRIP/TAPE

ETHICON trademark for a flat

band 5mm wide. Useful as a

cerclage ligature in patients with an

incompetent cervix. Also used for

bladder support or repair and

support of the rotator cuff in

the shoulder.

MERSILENE* POLYESTER

FIBER SUTURE

ETHICON trademark for uncoated

braided nonabsorbable suture

material made of polyester polymer.

MICRO-POINT*

SPATULA NEEDLE

ETHICON trademark for

side-cutting ophthalmic needles

which are thin and flat in profile

and specially honed for exceptional

sharpness.

MICRO-POINT*

SURGICAL NEEDLE

ETHICON trademark for

ophthalmic needles which are

honed and polished to an extremely

fine finish and sharpness.

MICROSURGERY SUTURES

Sutures for surgeries in which an

operating microscope may be used

to visualize the very small structures

involved, e.g., blood vessels

and nerves.

MIL

Unit of linear measurement,

equivalent to 0.001 inch. Frequently

used to express wire diameter of

surgical needles.

PRODUCT TERMS AND TRADEMARKS

MODULAR SUTURE

STORAGE RACK

Plastic modules of expandable

interlocking units that provide neat,

convenient storage of ETHICON

suture dispenser boxes.

MONOCRYL*

(POLIGLCAPRONE 25) SUTURE

ETHICON trademark for

monofilament synthetic absorbable

suture prepared from a copolymer

of glycolide and e-caprolactone.

MONOFILAMENT

A single filament strand.

MULTIFILAMENT

Strand made of more than one

twisted or braided filament.

MULTI-STRAND PACKAGE

Multiple swaged sutures of one type

supplied in a single packet.

NEEDLEHOLDER

Surgical instrument used to hold

and drive a surgical needle during

suturing.

NEEDLE/SUTURE

JUNCTION (SWAGE)

Point at which eyeless needles and

suture strands are joined.

NUROLON* BRAIDED

NYLON SUTURE

ETHICON trademark for

multifilament braided nylon suture.

NONABSORBABLE SUTURE

Material which tissue enzymes can-

not dissolve. Remains encapsulated

when buried in tissues. Removed

postoperatively when used as skin

suture.

NYLON

Synthetic suture material made of

polyamide polymer.

OB-GYN SUTURES

Needle/suture combinations

particularly useful in obstetric and

gynecological operations.

OPHTHALMIC SUTURES

Small gauge sutures attached to

ultrafine needles that meet exacting

needs in ophthalmic surgery.

OVERWRAP

Exterior packet which protects the

sterility of inner suture packet.

PACKAGE INSERT

Complete product information

inserted in every box of wound

closure products, as required by

the FDA.

PC PRIME* NEEDLE (PC)

ETHICON trademark for a

conventional cutting needle with a

geometry that reduces the angle of

the cutting edge. Requires less force

to penetrate tissue, minimizing

tissue trauma in precision

cosmetic surgery.

PDS* II (POLYDIOXANONE)

SUTURE

ETHICON trademark for

monofilament synthetic absorbable

suture prepared from the polyester

poly (p-dioxanone).

PERMA-HAND* SILK SUTURE

ETHICON trademark for sutures

specially processed to remove gum

and impurities from raw silk before

braiding selected sizes into strands.

Also treated with mismo beeswax to

reduce capillarity.

PLAIN SURGICAL GUT

Untreated absorbable suture with

short-term absorption profile.

PLASTIC SURGERY SUTURES

Sutures specifically designed to

assist the surgeon in obtaining

excellent cosmetic results in plastic

and reconstructive surgery.

PLEDGETS

Small pieces of TFE polymer felt

used as a buttress under sutures in

cardiovascular surgery.

POLYBUTILATE

A nonabsorbable nonreactive

polyester lubricant developed by

ETHICON, INC., as a coating for

ETHIBOND EXCEL sutures.

POLYESTER FIBER

Synthetic material made of a

polyester polymer of polyethylene

terephthalate.

POLYPROPYLENE

Synthetic material of an isotactic

crystalline stereoisomer of a linear

hydrocarbon polymer which will

not absorb fluids.

POLYPROPYLENE BUTTONS

Synthetic material made into

buttons. Useful in orthopaedic

procedures such as tendon repair.

Sutures are tied over buttons to

relieve underlying skin of excessive

pressure.

PRECISION COSMETIC

NEEDLE (PC)

Conventional cutting needles

specially polished and carefully

honed for aesthetic plastic surgery.

* Trademark

CHAPTER 7 83

PRECISION POINT NEEDLE

Reverse-cutting needles specially

polished and carefully honed for

plastic surgery.

PRE-CUT SUTURES

Strands of suture material packaged

pre-cut into various lengths.

PRIMARY PACKET

Suture packet which contains the

sterile suture.

PRIMARY WOUND CLOSURE

The approximation of wound edges

to facilitate rapid healing.

PRODUCT CODE

Numbers or combination of letters

and numbers which identify a

specific product.

PROLENE* POLYPROPYLENE

HERNIA SYSTEM

ETHICON trademark for a sterile,

pre-shaped, three-dimensional

device constructed of an onlay patch

connected by a mesh cylinder to a

circular underlay patch. Used for

the repair of indirect and direct

inguinal hernia defects.

PROLENE* POLYPROPYLENE

MESH

ETHICON trademark for mesh

made of polypropylene which is

knitted by a process which inter-

links each fiber juncture. Used for

the repair of abdominal wall defects

and tissue deficiencies.

PROLENE* POLYPROPYLENE

SUTURE

ETHICON trademark for synthetic

nonabsorbable suture material made

of monofilament polypropylene.

PRONOVA* POLY

(HEXAFLUOROPROPYLENE-VDF)

SUTURE

ETHICON trademark for synthetic

nonabsorbable suture material made

of a polymer blend of poly

(vinylidene fluoride) and poly

(vinylidene fluoride-cohexafluoro-

propylene).

PROXI-STRIP* SKIN CLOSURES

ETHICON trademark for adhesive

strips used for skin closure.

RELAY* SUTURE

DELIVERY SYSTEM

ETHICON trademark for the

packaging of single strand and

multistrand sutures. Provides

delivery of one suture at a time,

one-step arming, individual needle

parks, and straight, tangle-free

sutures ready for use.

RETENTION SUTURE

BOLSTERS

Surgical tubing used to sheath

retention sutures to prevent cutting

the skin. Also known as "Booties."

RETENTION SUTURE BRIDGE

Clear plastic device designed with a

capstan to permit postoperative

wound management by adjusting

the tension of retention sutures,

preventing suture crosshatching on

the skin.

REVERSE CUTTING NEEDLE

Needles produced by ETHICON

Products, which have triangular

shapethroughout their entire length

and cutting edge along the outside

needle curvature to prevent

tissue cutout. Needles with

longitudinal grooves on the inner

and outer flattened curvatures. Ribs

engage the needleholder jaw and

help to minimize movement of the

needle in the needleholder.

SABRELOC* SPATULA NEEDLE

ETHICON trademark for

ophthalmic needles. Side-cutting

spatula-shaped edges separate the

ultrathin layers of scleral or comeal

tissue without cutting through.

SAFETY ORGANIZER TRAY

ETHICON design for a suture tray

which delivers multistrand products.

Offers single strand delivery, and a

singulated needle park which

permits one-step arming and

tanglefree straight suture strands.

SECONDARY CLOSURE

Retention sutures placed

approximately 2 inches from wound

edges to reinforce primary closure

and protect it from stress.

SIDE-FLATTENED NEEDLES

Configuration of stainless steel alloy

needles designed to increase

strength and reduce bending when

penetrating vascular prostheses or

calcified tissues.

SINGLE STRAND DELIVERY

Terminology used to describe the

delivery of one straight suture at a

time from the RELAY suture

delivery system.

PRODUCT TERMS AND TRADEMARKS

STERILE

Free of living microorganisms

(bacteria and their spores,

viruses, etc.).

STERILE TECHNIQUE

Collectively, all the efforts made and

procedures followed to exclude

microorganisms from the operative

wound and field.

STERILIZATION

Process by which all living

microorganisms on an object are

destroyed.

SUPER-SMOOTH FINISH

An exclusive process that provides a

finish on most ETHICON needles,

enabling the needles to penetrate

and pass through the toughest tissue

with minimal resistance.

SURGICAL GUT

Absorbable suture made from

serosal layer of beef intestine or

submucosal layer of sheep intestine.

SURGICAL STAINLESS

STEEL SUTURE

Nonabsorbable suture made of

316L steel alloy.

SUTUPAK* PRE-CUT

STERILE SUTURES

ETHICON trademark for packet

containing multiple pre-cut lengths

of suture material without needles,

sterile and ready for immediate use.

SUTURE

Material used to approximate

(sew) tissues or tie off (ligate)

blood vessels.

SUTURE BOOK

Sterile towel folded by the scrub

person and used to contain multiple

sutures.

SWAGED SUTURE

Strand of material with eyeless nee-

dle attached by the manufacturer.

TAPERCUT*

SURGICAL NEEDLE

ETHICON trademark for a needle

which has a 1/16" triangular tip with

three cutting edges. Remainder of

needle has a gradually tapered body.

TAPER POINT NEEDLE (TP)

Needle with a body that gradually

tapers to a sharp point, making the

smallest possible hole in tissue.

TENSILE STRENGTH

Amount of tension or pull,

expressed in pounds, which a

suture strand will withstand before

it breaks.

TIES (LIGATURES)

Strands of suture used to tie off the

ends of severed blood vessels: free

or freehand—single strands used as

individual ties; continuous—long

strands unwound from a reel or

other device as blood vessels are

tied; suture ligature—strand on a

needle used to transfix (suture) a

large blood vessel to ensure security

against knot slippage; stick tie—a

suture ligature or a single strand

handed to surgeon for ligating with

a hemostat clamped on one suture

end; transfixion suture—suture

ligature.

TRANSVERSE GROUND

NEEDLES (TG)

Spatulated ophthalmic needles

specially honed to a long, sharp,

slim tip.

TRU-GAUGING

ETHICON process which ensures

uniform diameter and uniformly

higher tensile strength of

surgical gut.

TRU-PERMANIZING

ETHICON process of treating silk

for noncapillarity.

TUBING FLUID

Solution inside packets of surgical

gut and collagen. Purpose is to

maintain material (and needle, if

attached) in optimum condition for

immediate use upon withdrawal

from the packet.

UMBILICAL TAPE

Woven cotton tape, classified as a

ligature, used as a gentle means of

retracting vessels in cardiovascular

and pediatric surgery and for tying

off the umbilicus of the newbom.

UROLOGICAL SUTURES

Sutures designed to meet the needs

of surgery performed by urologists.

Features 5/8circle needles which

turn out of tissue quickly.

VICRYL* (POLYGLACTIN 910)

MESH

ETHICON trademark for mesh

prepared from a copolymer of

glycolide and lactide. An absorbable

material used as a buttress to

provide temporary support during

healing.

* Trademark

CHAPTER 7 85

VICRYL* (POLYGLACTIN 910)

PERIODONTAL MESH

ETHICON trademark for mesh

prepared from a copolymer of gly-

colide and lactide. An absorbable

material used in periodontal surgery

for guided tissue regeneration.

VISI-BLACK* SURGICAL

NEEDLES

ETHICON trademark for surgical

needles with a black surface

finish to enhance visibility in the

operative site.

WOUND DISRUPTION

Separation of wound edges.

PRODUCT TERMS AND TRADEMARKS

* Trademark

PRODUCT INFORMATION

CHAPTER 8

PRODUCT INFORMATION

Coated VICRYL*

(Polyglactin 910) Suture

U.S.P., EXCEPT FOR DIAMETER

DESCRIPTION

Coated VICRYL* (polyglactin 910) suture is a synthetic absorbable sterile

surgical suture composed of a copolymer made from 90% glycolide and 10%

L-lactide. Coated VICRYL suture is prepared by coating VICRYL suture material

with a mixture composed of equal parts of copolymer of glycolide and lactide

(polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and

polyglactin 370 with calcium stearate have been found to be nonantigenic,

nonpyrogenic and elicit only a mild tissue reaction during absorption.

The sutures are available dyed and undyed (natural).

Coated VICRYL sutures are U.S.P. except for diameters in the following sizes:

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.

U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm)

6-0 .008

5-0 .016

4-0 .017

3-0 .018

2-0 .004

0 .022

INDICATIONS

Coated VICRYL suture is indicated for use in general soft tissue approximation

and/or ligation, including use in ophthalmic procedures, but not for use in

cardiovascular and neurological tissues.

ACTIONS

Coated VICRYL suture elicits a minimal acute inflammatory reaction in tissue

and ingrowth of fibrous connective tissue. Progressive loss of tensile strength

and eventual absorption of coated VICRYL suture occurs by means of

hydrolysis, where the copolymer degrades to glycolic and lactic acids which

are subsequently absorbed and metabolized in the body. Absorption begins as

a loss of tensile strength followed by a loss of mass. Implantation studies in

rats indicate that coated VICRYL suture retains approximately 75% of the

original tensile strength at two weeks post implantation. At three weeks,

approximately 50% of the original strength is retained for sizes 6-0 and larger

and approximately 40% of its original strength is retained for sizes 7-0 and

smaller. At four weeks, approximately 25% of the original strength is retained

for sizes 6-0 and larger. All of the original tensile strength is lost by five weeks

post implantation. Absorption of coated VICRYL suture is essentially complete

between 56 and 70 days.

APPROXIMATE % ORIGINAL

DAYS IMPLANTATION STRENGTH REMAINING

14 Days 75%

21 Days (6-0 and larger) 50%

21 Days (7-0 and smaller) 40%

28 Days 25%

CONTRAINDICATIONS

This suture, being absorbable, should not be used where extended

approximation of tissue is required.

WARNINGS

Users should be familiar with surgical procedures and techniques involving

absorbable sutures before employing coated VICRYL suture for wound

closure, as risk of wound dehiscence may vary with the site of application and

the suture material used. Physicians should consider the in vivo performance

(under ACTIONS section) when selecting a suture. The use of this suture may

be inappropriate in elderly, malnourished, or debilitated patients, or in patients

suffering from conditions which may delay wound healing. As this is an

absorbable suture material, the use of supplemental nonabsorbable sutures

should be considered by the surgeon in the closure of the sites which

may undergo expansion, stretching or distention, or which may require

additional support.

Do not resterilize. Discard opened packages and unused sutures.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus

formation. As an absorbable suture, coated VICRYL suture may act

transiently as a foreign body. Acceptable surgical practice should be followed

for the management of contaminated or infected wounds.

PRECAUTIONS

Skin sutures which must remain in place longer than 7 days may cause

localized irritation and should be snipped off or removed as indicated.

Under some circumstances, notably orthopaedic procedures, immobilization of

joints by external support may be employed at the discretion of the surgeon.

Consideration should be taken in the use of absorbable sutures in tissues with

poor blood supply as suture extrusion and delayed absorption may occur.

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders. Coated VICRYL

sutures, which are treated to enhance handling characteristics, require the

accepted surgical technique of flat and square ties with additional throws as

warranted by surgical circumstance and the experience of the surgeon.

Avoid prolonged exposure to elevated temperatures.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to the

point. Reshaping needles may cause them to lose strength and be less resistent

to bending and breaking. Users should exercise caution when handling

surgical needles to avoid inadvertent needle sticks. Discard used needles in

"sharps" container.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound

dehiscence, failure to provide adequate wound support in closure of the sites

where expansion, stretching, or distension occur, failure to provide adequate

wound support in elderly, malnourished or debilitated patients or in patients

suffering from conditions which may delay wound healing, infection, minimal

acute inflammatory tissue reaction, localized irritation when skin sutures are

left in place for greater than 7 days, suture extrusion and delayed absorption in

tissue with poor blood supply, calculi formation in urinary and biliary tracts

when prolonged contact with salt solutions such as urine and bile occurs, and

transitory local irritation at the wound site. Broken needles may result in

extended or additional surgeries or residual foreign bodies. Inadvertent needle

sticks with contaminated surgical needles may result in the transmission of

bloodborne pathogens.

HOW SUPPLIED

Coated VICRYL sutures are available sterile, as braided dyed (violet) and

undyed (natural) strands in sizes 8-0 through 3 (metric sizes 0.4-6), in a variety

of lengths, with or without needles, and on LIGAPAK*dispensing reels.

Coated VICRYL sutures are also available in size 8-0 with attached beads for

use in ophthalmic procedures. Coated VICRYL sutures are also available in

sizes 4-0 through 2 (metric sizes 1.5-5.0) attached to CONTROL RELEASE*

removable needles. Coated VICRYL sutures are available in one, two, and three

dozen boxes.

CHAPTER 8 89

Coated VICRYL* RAPIDE (Polyglactin 910)

Braided Coated Synthetic Absorbable

Suture, Undyed

Non-U.S.P.

DESCRIPTION

Coated VICRYL* RAPIDE (polyglactin 910) suture is a synthetic absorbable ster-

ile surgical suture composed of a copolymer made from 90% glycolide and 10%

L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n.

The characteristic of rapid loss of strength is achieved by use of a polymer

material with a lower molecular weight than coated VICRYL* (polyglactin 910)

suture.

Coated VICRYL RAPIDE sutures are obtained by coating the braided suture

material with a mixture composed of equal parts of copolymer of glycolide and

lactide (polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and

polyglactin 370 with calcium stearate have been found to be nonantigenic,

nonpyrogenic and elicit only a mild tissue reaction during absorption.

Coated VICRYL RAPIDE sutures are only available undyed.

Although this suture is a synthetic absorbable suture, its performance charac-

teristics are intended to model the performance of collagen (surgical gut)

suture. The knot tensile strength of coated VICRYL RAPIDE suture meets U.S.P.

knot tensile strength requirements for collagen sutures, however, Coated

VICRYL RAPIDE suture strength is up to 26% less than knot tensile strength

requirements for synthetic absorbable sutures.

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.

U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE(mm)

5-0 .016

4-0 .017

3-0 .018

2-0 .010

0 .022

INDICATIONS

Coated VICRYL RAPIDE synthetic absorbable suture is indicated only for use in

superficial soft tissue approximation of the skin and mucosa, where only short

term wound support (7-10 days) is required. Coated VICRYL RAPIDE suture is

not intended for use in ligation, ophthalmic, cardiovascular or neurological

procedures.

ACTIONS

Coated VICRYL RAPIDE suture, when used in closure of skin and mucous

membranes, typically begins to fall off 7-10 days post-operatively and can be

wiped off subsequently with sterile gauze. Natural mechanical abrasion of the

sutures while in situ may also accelerate this disappearance rate. Rapid loss of

tensile strength may preclude the need for stitch removal.

Coated VICRYL RAPIDE elicits a minimal to moderate acute inflammatory

reaction in tissue. Progressive loss of tensile strength and eventual absorption

of coated VICRYL RAPIDE occurs by means of hydrolysis, where the copolymer

degrades to glycolic and lactic acids which are subsequently absorbed and

metabolized in the body. Absorption begins as a loss of tensile strength

followed by a loss of mass.

Subcutaneous tissue implantation studies of coated VICRYL RAPIDE sutures in

rats show that 5 days post-implantation approximately 50% of the original

tensile strength remains. All of the original tensile strength is lost by approxi-

mately 10 to 14 days post-implantation. Intramuscular implantation studies in

rats show that the absorption of these sutures occurs thereafter and is

essentially complete by 42 days.

CONTRAINDICATIONS

Due to the rapid loss of tensile strength, this suture should not be used where

extended approximation of tissues under stress is required or where wound

support beyond 7 days is required.

WARNINGS

Users should be familiar with surgical procedures and techniques involving

absorbable sutures before employing coated VICRYL RAPIDE suture for wound

closure, as a risk of wound dehiscence may vary with the site of application and

the suture material used. Physicians should consider the in vivo performance

when selecting a suture. The use of this suture may be inappropriate in

elderly, malnourished, or debilitated patients, or in patients suffering from

conditions which may delay wound healing.

Do not resterilize. Discard opened packages and unused sutures.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus

formation. As an absorbable suture, coated VICRYL RAPIDE suture may act

transiently as a foreign body.

Acceptable surgical practice should be followed for the management of

contaminated or infected wounds.

As this is an absorbable suture material, the use of supplemental nonab-

sorbable sutures should be considered by the surgeon in the closure of sites

which may undergo expansion, stretching or distention, or which may require

additional support.

PRECAUTIONS

Skin sutures which remain in place longer than 7 days may cause localized

irritation and should be snipped off or removed as indicated.

Under some circumstances, notably orthopaedic procedures, immobilization of

joints by external support may be employed at the discretion of the surgeon.

Consideration should be taken in the use of absorbable sutures in tissues with

poor blood supply as suture extrusion and delayed absorption may occur.

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders.

Coated VICRYL RAPIDE suture, which is treated with coating to enhance

handling characteristics, requires the accepted surgical technique of flat and

square ties with additional throws as warranted by surgical circumstance and

the experience of the surgeon.

Avoid prolonged exposure to elevated temperatures.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to the

point. Reshaping needles may cause them to lose strength and be less

resistant to bending and breaking.

Users should exercise caution when handling surgical needles to avoid in

advertent needle sticks. Discard used needles in “sharps” containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound dehis-

cence, failure to provide adequate wound support in closure of the sites where

expansion, stretching, or distension occur, failure to provide adequate wound

support in elderly, malnourished or debilitated patients or in patients suffering

from conditions which may delay wound healing, infection, minimal acute

inflammatory tissue reaction, localized irritation when skin sutures are left in

place for greater than 7 days, suture extrusion and delayed absorption in tissue

with poor blood supply, calculi formation in urinary and biliary tracts when pro-

longed contact with salt solutions such as urine and bile occurs, and transitory

local irritation at the wound site. Broken needles may result in extended or

additional surgeries or residual foreign bodies. Inadvertent needle sticks with

contaminated surgical needles may result in the transmission of bloodborne

pathogens.

HOW SUPPLIED

Coated VICRYL RAPIDE sutures are available sterile, undyed and attached to

stainless steel needles of varying types and sizes.

Coated VICRYL RAPIDE sutures are available in various lengths in sizes 5-0 to

1 (1.0 to 4.0 metric) in one and three dozen boxes.

PRODUCT INFORMATION

DERMABOND* Topical Skin Adhesive

(2-Octyl Cyanoacrylate)

DESCRIPTION

DERMABOND topical skin adhesive is a sterile, liquid topical skin adhesive

containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant

D & C Violet #2. It is provided in a single use applicator packaged in a blister pouch.

The applicator is comprised of a crushable glass ampule contained within a

plastic vial with attached applicator tip. As applied to the skin, the liquid adhesive

is slightly more viscous than water and polymerizes within minutes.

INDICATIONS

DERMABOND Topical Skin Adhesive is intended for topical application only to

hold closed easily approximated skin edges of wounds from surgical incisions,

including punctures from minimally invasive surgery, and simple, thoroughly

cleansed, trauma-induced lacerations. DERMABOND adhesive may be used in

conjunction with, but not in place of, subcuticular sutures.

CONTRAINDICATIONS

• Do not use on any wound with evidence of active infection, gangrene, or

wounds of decubitus etiology.

• Do not use on mucosal surfaces or across mucocutaneous junctions (e.g., oral

cavity, lips), or on skin which may be regularly exposed to body fluids or with

dense natural hair, (e.g., scalp).

• Do not use on patients with a known hypersensitivity to cyanoacrylate or

formaldehyde.

WARNINGS

• DERMABOND adhesive is a fast setting adhesive capable of adhering to most

body tissue and many other materials, such as latex gloves and stainless steel.

Inadvertent contact with any body tissue, and any surfaces or equipment that

are not disposable or that cannot be readily cleaned with a solvent such as

acetone should be avoided.

• Polymerization of DERMABOND adhesive may be accelerated by water or

fluids containing alcohol: DERMABOND adhesive should not be applied to

wet wounds.

• DERMABOND adhesive should not be applied to the eye. If contact with the

eye occurs, flush the eye copiously with saline or water. If residual adhesive

remains, apply topical ophthalmic ointment to help loosen the bond and contact

an ophthalmologist.

• When closing facial wounds near the eye with DERMABOND adhesive, position

the patient so that any run-off of adhesive is away from the eye. The eye should

be closed and protected with gauze. Prophylactic placement of petroleum jelly

around the eye, to act as a mechanical barrier or dam, can be effective in

preventing inadvertent flow of adhesive into the eye. DERMABOND adhesive

will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using

petroleum jelly on any skin area where DERMABOND adhesive is intended

to adhere. Use of DERMABOND adhesive near the eye has inadvertently

caused some patient’s eyelids to be sealed shut. In some of these cases,

general anesthesia and surgical removal has been required to open the eyelid.

• DERMABOND adhesive should not be used below the skin because the poly-

merized material is not absorbed by tissue and can elicit a foreign body reaction.

• DERMABOND adhesive should not be used in high skin tension areas or across

areas of increased skin tension, such as knuckles, elbows, or knees, unless the

joint will be immobilized during the skin healing period.

• DERMABOND adhesive treated wounds should be monitored for signs of

infection. Wounds with signs of infection, such as erythema, edema, warmth,

pain and pus, should be evaluated and treated according to standard practice

for infection.

• DERMABOND adhesive should not be used on wound sites that will be subject-

ed to repeated or prolonged moisture or friction.

• DERMABOND adhesive should only be used after wounds have been

cleaned and debrided in accordance with standard surgical practice. Local

anesthetic should be used when necessary to assure adequate cleansing

and debridement.

• Excessive pressure of the applicator tip against wound edges or surrounding

skin can force the wound edges apart and allow adhesive into the wound.

Adhesive within the wound could delay wound healing and/or result in adverse

cosmetic outcome. Therefore, DERMABOND adhesive should be applied with

a very light brushing motion of the applicator tip over easily approximated

wound edges.

• DERMABOND adhesive polymerizes through an exothermic reaction in which

a small amount of heat is released. With the proper technique of applying

DERMABOND adhesive in multiple thin layers (at least three) onto a dry wound

and allowing time for polymerization between applications, heat is released

slowly and the sensation of heat or pain experienced by the patient is minimized.

However, if DERMABOND adhesive is applied so that large droplets of liquid are

allowed to remain unspread, the patient may experience a sensation of heat or

discomfort.

• DERMABOND adhesive is packaged for single patient use. Discard remaining

opened material after each wound closure procedure.

• Do not resterilize DERMABOND adhesive.

• Do not place DERMABOND adhesive in a procedure pack /tray that is to be ster-

ilized prior to use. Exposure of DERMABOND adhesive, after its final manufac-

ture, to excessive heat (as in autoclaves or ethylene oxide sterilization) or radia-

tion (such as gamma or electron beam), is known to increase its viscosity and

may render the product unusable.

PRECAUTIONS

• Do not apply liquid or ointment medications or other substances to the wound

after closure with DERMABOND adhesive, as these substances can weaken the

polymerized film and allow for wound dehiscence. DERMABOND adhesive

permeability by topical medications has not been studied.

• DERMABOND adhesive permeability by fluids is not known and has not

been studied.

• DERMABOND adhesive is a free flowing liquid slightly more viscous than water.

To prevent inadvertent flow of liquid DERMABOND adhesive to unintended

areas: (1) the wound should be held in a horizontal position, with DERMABOND

adhesive applied from above, and (2) DERMABOND adhesive should be

applied in multiple (at least 3), thin layers rather than in a few large droplets.

• Hold applicator away from yourself and the patient and break ampule close

to its center one time only. Do not crush the contents of the applicator tube

repeatedly as further manipulation of the applicator may cause glass shard

penetration of the outer tube.

• DERMABOND adhesive should be used immediately after crushing the glass

ampule as the liquid adhesive will not flow freely from the applicator tip after a

few minutes.

• If unintended bonding of intact skin occurs, peel, but do not pull the skin apart.

Petroleum jelly or acetone may help loosen the bond. Other agents such as

water, saline, Betadine® Antibiotics, HIBICLENS†(chlorhexidene gluconate), or

soap, are not expected to immediately loosen the bond.

• Safety and effectiveness of DERMABOND adhesive on wounds of patients with

peripheral vascular disease, insulin dependent diabetes mellitus, blood clotting

disorders, personal or family history of keloid formation or hypertrophy, or burst

stellate lacerations, have not been studied.

• Safety and effectiveness of DERMABOND adhesive on the following wounds

have not been studied: animal or human bites, puncture or stab wounds.

• Safety and effectiveness on wounds that have been treated with DERMABOND

adhesive and then exposed for prolonged periods to direct sunlight or tanning

lamps have not been studied.

• Safety and effectiveness of DERMABOND adhesive on wounds in vermilion

surfaces has not been studied.

CHAPTER 8 91

ADVERSE REACTIONS

• Adverse reactions encountered during clinical study:

*In the clinical study, presence of infection was to be identified by observation

of redness more than 3–5 mm from the repaired wound, swelling, purulent

discharge, pain, increased skin temperature, fever, or other systemic signs of

infection. (See clinical study). Confirmatory culture was not routinely obtained.

Among cases of suspected infection for DERMABOND adhesive, 7/14 (50%) were

in patients less than 12 years old with traumatic lacerations; overall, 8 of the 14

(approximately 60%) DERMABOND adhesive wounds with suspected infections

were associated with sub-optimal cosmetic outcome.

• Reactions may occur in patients who are hypersensitive to cyanoacrylate or

formaldehyde. See CONTRAINDICATIONS.

• The polymerization of DERMABOND adhesive on the skin releases small

amounts of heat which may cause a sensation of heat or discomfort in some

patients.

• Adverse reactions may be experienced following DERMABOND adhesive

contact with the eye.

CLINICAL STUDY

Description: A prospective, randomized, controlled, unmasked study was

conducted to evaluate the safety and effectiveness of closing the approximated

skin edges of surgical incisions, including punctures from minimally invasive

surgery, and trauma-induced lacerations using DERMABOND adhesive in

comparison to U.S.P. size 5-0 or smaller suture, adhesive strips or staples, with or

without dermal closure (subcuticular stitch) as per investigator judgment.

Summary of Effectiveness Results Comparing Dermabond adhesive to Sutures

(U.S.P. size 5-0 and smaller diameter), Staples, and Adhesive Strips

* Cosmesis: Modified Hollander Cosmesis Scale

The study population included patients at least one year of age, in good general

health, who signed informed consent and agreed to follow-up visits. Patients were

excluded if presenting with: significant multiple trauma, peripheral vascular

disease, insulin dependent diabetes mellitus, blood clotting disorder, keloid for-

mation or hypertrophy history (patient or family), cyanoacrylate or formaldehyde

allergy, burst or stellate lacerations due to crush or hard blow, animal or human

bite, and decubitus ulcer.

Follow-up was at 5–10 days and at 3 months. All wounds were assessed by

visual inspection at 5–10 days after wound closure. The total kinds of wounds

treated in the study were 46.1% lacerations and 53.9% incisions. The incisions

were comprised of 47.8% excisions of skin lesions, 27.4% minimally invasive

surgery punctures, and 24.8% general surgery incisions.

For wounds closed without subcuticular stitches, mean wound length was 1.5cm,

mean wound width was 2.5mm, and mean wound depth was 5.8mm. For wounds

closed with subcuticular stitches, mean wound length was 3.2cm, mean wound

width was 5.3mm, and mean wound depth was 3.8mm.

If the primary method of closure was insufficient for closure, an additional secur-

ing device was placed. The time to perform treatment included the time required

later to remove the closure device when applicable.

The Modified Hollander Cosmesis Scale (MHCS), a validated scale, was used to

evaluate cosmesis at three months: step-off borders, edge inversion, contour

irregularities, excess inflammation, wound margin separation, and overall

appearance.

HOW SUPPLIED

DERMABOND adhesive is supplied sterile, in a pre-filled, single-use applicator.

The applicator is comprised of a crushable glass ampule contained within a plas-

tic vial with attached applicator tip. The applicator contains 0.5ml of liquid adhe-

sive. The applicator is packaged in a blister pouch to maintain the device sterile

until opened or damaged.

DERMABOND adhesive may be available in boxes of 6 or 12 applicators.

STORAGE

Recommended storage conditions: below 30°C, 86°F, away from moisture and

direct heat. Do not use after expiry date.

STERILITY

DERMABOND adhesive is originally sterilized by dry heat and ethylene oxide gas.

Do not resterilize. Do not use if package is opened or damaged. Discard any

unused material following completion of medical procedure.

STERILE SINGLE USE ONLY

REPORTING

Physicians should use the following toll free number 1-800-255-2500 (valid in

U.S.A. only), when reporting adverse reactions or potentially threatening

complications involving DERMABOND adhesive.

CAUTION

Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.

® Trademark of Purdue Fredericks

† Registered Trademark of Zeneca Pharmaceuticals

Clinical Study Outcomes No With

Subcuticular Subcuticular

Sutures Sutures

DERMABOND Control DERMABOND Control

N (%) N (%) N (%) N (%)

Accounting

N, patients enrolled 240 243 167 168

N, patients treated 239 242 167 166

Patients completed 228 (95%) 215 (88%) 164 (98%) 162 (96%)

Adverse Reactions

Suspected Infection* 8 (3.6%) 2 (0.9%) 6 (3.6%) 2 (1.2%)

Wound type

# Lacerations 8 2 1 0

# Incisions 0 0 5 2

Dehiscence with Need 6 (2.5%) 5 (2.1%) 3 (1.8%) 0

for Retreatment

Acute Inflammation

Erythema 26 (11.5%) 74 (33.0%) 52 (31.3%) 75 (45.1%)

Edema 22 (9.7%) 28 (12.5%) 62 (37.3%) 71 (42.8%)

Pain 14 (6.1%) 13 (5.8%) 56 (33.7%) 57 (34.3%)

Warmth 3 (1.3%) 6 (2.6%) 3 (1.8%) 4 (2.4%)

Clinical Study Outcomes NSS WSS

DERMABOND Control DERMABOND Control

N (%) N (%) N (%) N (%)

Accounting

N, patients enrolled 240 243 167 168

N, patients treated 239 242 167 166

Patients completed 228 (95%) 215 (88%) 164 (98%) 162 (96%)

N, control:

suture/strips/staples/missing 194/46/1/1 116/45/5/0

Wound Closure Assessment

Immediate: Additional Devices 18 (7.5%) 13 (5.4%) 2 (1.2%) 11 (6.6%)

@ 5–10 days:

100% epidermal

apposition 169 (75.1%) 199 (88.8%) 140 (84.3%) 160 (96.4%)

>50% epidermal apposition 205 (91.1%) 214 (95.5%) 163 (98.2%) 165 (99.4%)

@ 3 months:

Cosmesis Score*= 0 (optimal) 188 (82.5%) 180 (83.7%) 128 (78.0%) 128 (79.0%)

Median Time for

Treatment (Minutes) 1.5 6.0 1.3 2.9

ETHIBOND* EXCEL POLYESTER SUTURE

NONABSORBABLE SURGICAL SUTURE, U.S.P.

Except for size 6-0 diameter

DESCRIPTION

ETHIBOND* EXCEL polyester suture is a nonabsorbable, braided, sterile,

surgical suture composed of Poly (ethylene terephthalate). It is prepared from

fibers of high molecular weight, long-chain, linear polyesters having recurrent

aromatic rings as an integral component. ETHIBOND EXCEL suture is uniform-

ly coated with polybutilate or poly {oxy-1, 4 butanediyloxy (1, 6-dioxo-1,

6 hexanediyl)}. The highly adherent coating is a relatively nonreactive

nonabsorbable compound which acts as a lubricant to mechanically improve

the physical properties of the uncoated suture by improving ease of passage

through tissues and by providing overall improved handling qualities as

contrasted to the braided, uncoated fiber.

ETHIBOND EXCEL sutures are braided for optimal handling properties, and for

good visibility in the surgical field, are dyed green.

Size 6-0 ETHIBOND EXCEL sutures are U.S.P., except for diameter.

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.

U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm)

6-0 0.024

INDICATIONS

ETHIBOND EXCEL suture is indicated for use in general soft tissue

approximation and/or ligation, including use in cardiovascular, ophthalmic and

neurological procedures.

ACTIONS

ETHIBOND EXCEL suture elicits a minimal acute inflammatory reaction in

tissue, followed by a gradual encapsulation of the suture by fibrous connective

tissue. Implantation studies in animals show no meaningful decline in

polyester suture strength over time. Both polyester fiber suture material and

the polybutilate coating are pharmacologically inactive.

CONTRAINDICATIONS

None known.

WARNINGS

Users should be familiar with surgical procedures and techniques involving

nonabsorbable sutures before employing ETHIBOND EXCEL suture for wound

closure, as risk of wound dehiscence may vary with the site of application and

the suture material used.

Do not resterilize. Discard opened packages and unused sutures.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus

formation. Acceptable surgical practice should be followed for the

management of infected or contaminated wounds.

PRECAUTIONS

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders.

As with any suture material, adequate knot security requires the accepted

surgical technique of flat and square ties with additional throws as warranted

by surgical circumstance and the experience of the surgeon.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to the

point. Reshaping needles may cause them to lose strength and be less

resistant to bending and breaking. Users should exercise caution when

handling surgical needles to avoid inadvertent needle sticks. Discard used

needles in "sharps" containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound

dehiscence, calculi formation in urinary and biliary tracts when prolonged

contact with salt solutions such as urine and bile occurs, infection, minimal

acute inflammatory tissue reaction and transitory local irritation at the wound

site. Broken needles may result in extended or additional surgeries or residual

foreign bodies. Inadvertent needle sticks with contaminated surgical needles

may result in the transmission of bloodborne pathogens.

HOW SUPPLIED

ETHIBOND EXCEL sutures are available as sterile, braided, green and undyed

(white) strands in sizes 7-0 through 5 (metric sizes 0.5-7) in a variety of lengths,

with and without permanently attached needles.

ETHIBOND EXCEL sutures, green, braided, in sizes 4-0 through 1 (metric sizes

1.5-4) are also available attached to CONTROL RELEASE* removable needles.

ETHIBOND EXCEL sutures, green and undyed, are also available attached to

TFE polymer pledgets measuring 1/8" x 1/8" x 1/16" (3.0mm x 3.0mm x 1.5mm),

1/4" x 1/8" x 1/16" (7.0mm x 3.0mm x 1.5mm).

ETHIBOND EXCEL sutures are available in one, two and three dozen boxes.

PRODUCT INFORMATION

CHAPTER 8 93

ETHILON* NYLON SUTURE

NONABSORBABLE SURGICAL SUTURES, U.S.P.

DESCRIPTION

ETHILON* nylon suture is a nonabsorbable, sterile surgical monofilament

suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6.

ETHILON sutures are dyed black or green to enhance visibility in tissue. The

suture is also available undyed (clear).

ETHILON suture meets all requirements established by the United States

Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

INDICATIONS

ETHILON suture is indicated for use in general soft tissue

approximation and/or ligation, including use in cardiovascular,

ophthalmic and neurological procedures.

ACTIONS

ETHILON suture elicits a minimal acute inflammatory reaction in tissue, which

is followed by gradual encapsulation of the suture by fibrous connective tissue.

While nylon is not absorbed, progressive hydrolysis of the nylon in vivo may

result in gradual loss over time of tensile strength.

CONTRAINDICATIONS

Due to the gradual loss of tensile strength which may occur over prolonged

periods in vivo, nylon suture should not be used where permanent retention of

tensile strength is required.

WARNINGS

Users should be familiar with surgical procedures and techniques involving

nonabsorbable sutures before employing ETHILON suture for wound closure,

as the risk of wound dehiscence may vary with the site of application and the

suture material used.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus

formation. Acceptable surgical practice should be followed for the management

of contaminated or infected wounds.

Do not resterilize. Discard open packages and unused sutures.

PRECAUTIONS

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders.

As with any suture material, adequate knot security requires the accepted sur-

gical technique of flat and square ties, with additional throws as warranted by

surgical circumstance and the experience of the surgeon. The use of addition-

al throws may be particularly appropriate when knotting monofilaments.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point.

Reshaping needles may cause them to lose strength and be less resistant to

bending and breaking. Users should exercise caution when handling surgical

needles to avoid inadvertent needle sticks. Discard used needles in "sharps"

containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound dehis-

cence, gradual loss of tensile strength over time, calculi formation in urinary

and biliary tracts when prolonged contact with salt solutions such as urine and

bile occurs, infection, minimal acute inflammatory tissue reaction, and transi-

tory local irritation at the wound site. Broken needles may result in extended or

additional surgeries or residual foreign bodies. Inadvertent needle sticks with

contaminated surgical needles may result in the transmission of bloodborne

pathogens.

HOW SUPPLIED

ETHILON sutures are available as sterile monofilament strands in U.S.P. sizes

11-0 through 2 (metric sizes 0.1-5.0) in a variety of lengths, with and without

permanently attached needles. ETHILON sutures are available in one, two and

three dozen boxes.

PRODUCT INFORMATION

FAST ABSORBING

SURGICAL GUT (PLAIN)

ABSORBABLE SURGICAL SUTURES

Non-U.S.P.

DESCRIPTION

Fast absorbing surgical gut suture is a strand of collagenous material prepared

from the submucosal layers of the small intestine of healthy sheep, or from the

serosal layers of the small intestine of healthy cattle.

Fast absorbing surgical gut sutures are sterile and elicit only a slight to

minimal tissue reaction during absorption.

Fast absorbing surgical gut sutures differ from U.S.P. minimum strength

requirements by less than 30%.

INDICATIONS

Fast absorbing surgical gut sutures are intended for dermal (skin) suturing

only. They should be utilized only for external knot tying procedures.

ACTIONS

The results of implantation studies of fast absorbing surgical gut sutures in the

skin of animals indicate that nearly all of its original strength is lost within

approximately seven (7) days of implantation.

When surgical gut suture is placed in tissue, a moderate tissue inflammation

occurs which is characteristic of foreign body response to a substance. This is

followed by a loss of tensile strength followed by a loss of suture mass, as the

proteolytic enzymatic digestive process dissolves the surgical gut. This process

continues until the suture is completely absorbed. Many variable factors may

affect the rate of absorption. Some of the major factors which can affect tensile

strength loss and absorption rates are:

1. Type of suture - plain gut generally absorbs more rapidly than chromic gut.

2. Infection - surgical gut is absorbed more rapidly in infected tissue than in

non-infected tissue.

3. Tissue sites - surgical gut will absorb more rapidly in tissue where increased

levels of proteolytic enzymes are present, as in the secretions exhibited in

the stomach, cervix and vagina.

Data obtained from implantation studies in rats show that the absorption of

these sutures is essentially complete by the twenty-first (21st) to forty-second

(42nd) post implantation day.

CONTRAINDICATIONS

These sutures, being absorbable, should not be used where prolonged

approximation of tissue under stress is required. These sutures have been

designed to absorb at a rapid rate and must be used on dermal tissue only.

These sutures should never be used on internal tissue. The use of this suture

is contraindicated in patients with known sensitivities or allergies to collagen,

as gut is a collagen based material.

WARNINGS

Users should be familiar with surgical procedures and techniques involving gut

suture before using fast absorbing surgical gut suture for wound closure, as

the risk of wound dehiscence may vary with the site of application and the

suture material used. Physicians should consider the in vivo performance when

selecting a suture for use in patients.

The use of this suture may be inappropriate in elderly, malnourished, or debil-

itated patients, or in patients suffering from conditions which may delay

wound healing. As this is an absorbable material, the use of supplemental non-

absorbable sutures should be considered by the surgeon in the closure of sites

which may undergo expansion, stretching or distention or which may require

additional support.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus for-

mation. As an absorbable suture, fast absorbing surgical gut may act tran-

siently as a foreign body. Acceptable surgical practice should be followed for

the management of contaminated or infected wounds.

Do not resterilize. Discard open packages and unused sutures. Store at room

temperature.

Certain patients may be hypersensitive to collagen and might exhibit an

immunological reaction resulting in inflammation, tissue granulation or fibro-

sis, wound suppuration and bleeding, as well as sinus formation.

PRECAUTIONS

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders. Surgical gut sutures

require the accepted surgical technique of flat and square ties with additional

throws as warranted by surgical circumstance and the experience of the

surgeon.

Under some circumstances, notably orthopaedic procedures, immobilization of

joints by external support may be employed at the discretion of the surgeon.

The surgeon should avoid unnecessary tension when running down knots, to

reduce the occurrence of surface fraying and weakening of the strand.

Avoid prolonged exposure to elevated temperatures.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to

the point. Reshaping needles may cause them to lose strength and be less

resistant to bending and breaking. Users should exercise caution when

handling surgical needles to avoid inadvertent needle sticks. Discard used

needles in "sharps" containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound

dehiscence, variable rates of absorption over time (depending on such factors

as the type of suture used, the presence of infection and the tissue site), failure

to provide adequate wound support in closure of sites where expansion,

stretching or distention occur, etc., unless additional support is supplied

through the use of nonabsorbable suture material, failure to provide adequate

wound support in elderly, malnourished or debilitated patients or in patients

suffering from cancer, anemia, obesity, diabetes, infection or other conditions

which may delay wound healing, allergic response in patients with known

sensitivities to collagen which may result in an immunological reaction result-

ing in inflammation, tissue granulation or fibrosis, wound suppuration and

bleeding, as well as sinus formation, infection, moderate tissue inflammatory

response characteristic of foreign body response, calculi formation in urinary

and biliary tracts when prolonged contact with salt solutions such as urine and

bile occurs, and transitory local irritation at the wound site. Broken needles

may result in extended or additional surgeries or residual foreign bodies.

Inadvertent needle sticks with contaminated surgical needles may result in the

transmission of bloodborne pathogens.

HOW SUPPLIED

Fast absorbing surgical gut sutures are available in sizes 5-0 (metric size 1.5)

and 6-0 (metric size 1.0) with needles attached in one, two and three dozen

boxes.

CHAPTER 8 95

MERSILENE* POLYESTER FIBER SUTURE

NONABSORBABLE SURGICAL SUTURE, U.S.P.

Except for size 6-0 diameter

DESCRIPTION

MERSILENE* polyester suture is a nonabsorbable, braided, sterile, surgical

suture composed of Poly (ethylene terephthalate). It is prepared from fibers of

high molecular weight, long-chain, linear polyesters having recurrent aromatic

rings as an integral component. MERSILENE sutures are braided for optimal

handling properties, and for good visibility in the surgical field, are dyed green.

Size 6-0 MERSILENE sutures are U.S.P., except for diameter.

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.

U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm)

6-0 0.024

INDICATIONS

MERSILENE suture is indicated for use in general soft tissue approximation

and/or ligation, including use in cardiovascular, ophthalmic and neurological

procedures.

ACTIONS

MERSILENE suture elicits a minimal acute inflammatory reaction in tissue,

followed by a gradual encapsulation of the suture by fibrous connective

tissue. Implantation studies in animals show no meaningful decline in

polyester suture strength over time. The polyester fiber suture material is

pharmacologically inactive.

CONTRAINDICATIONS

None known.

WARNINGS

Users should be familiar with surgical procedures and techniques involving

nonabsorbable sutures before employing MERSILENE suture for wound

closure, as risk of wound dehiscence may vary with the site of application and

the suture material used.

Do not resterilize. Discard opened packages and unused sutures.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus for-

mation. Acceptable surgical practice should be followed for the management

of infected or contaminated wounds.

PRECAUTIONS

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders. The use of addition-

al throws is particularly appropriate when knotting monofilament sutures.

As with any suture material, adequate knot security requires the accepted

surgical technique of flat and square ties with additional throws as warranted

by surgical circumstance and the experience of the surgeon.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to

the point. Reshaping needles may cause them to lose strength and be less

resistant to bending and breaking. Users should exercise caution when

handling surgical needles to avoid inadvertent needle sticks. Discard used

needles in "sharps" containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound

dehiscence, calculi formation in urinary and biliary tracts when prolonged

contact with salt solutions such as urine and bile occurs, infection, minimal

acute inflammatory tissue reaction and transitory local irritation at the wound

site. Broken needles may result in extended or additional surgeries or residual

foreign bodies. Inadvertent needle sticks with contaminated surgical needles

may result in the transmission of bloodborne pathogens.

HOW SUPPLIED

MERSILENE sutures are available as sterile, braided, green and undyed (white)

strands in sizes 6-0 through 5 (metric sizes 0.7-7) in a variety of lengths, with

and without permanently attached needles.

MERSILENE sutures are also available in green monofilament in sizes 10-0 and

11-0 (metric sizes 0.2-0.1).

MERSILENE sutures, green, braided in U.S.P. size 0 (metric size 3.5) are also

available attached to CONTROL RELEASE* removable needles.

MERSILENE sutures are available in one, two and three dozen boxes.

PRODUCT INFORMATION

MERSILENE* POLYESTER FIBER MESH

Nonabsorbable Synthetic Surgical Mesh

STERILE

DESCRIPTION

MERSILENE* Polyester Fiber Mesh is constructed from polyethylene

terephthalate, the same material used to make MERSILENE* Polyester Fiber

Suture, Nonabsorbable Surgical Suture, U.S.P. (ETHICON, INC.) MERSILENE

Polyester Fiber Mesh affords excellent strength, durability and surgical

adaptability, along with maximal porosity for necessary tissue ingrowth.

The mesh is approximately 0.010 inches thick and is a highly flexible and

compliant material.

MERSILENE mesh is knitted by a process which interlinks each fiber junction

and which provides for elasticity in both directions. This construction permits

the mesh to be cut into any desired shape or size without unraveling. The fiber

junctions are not subject to the same work fatigue exhibited by more rigid

metallic meshes. This bi-directional elastic property allows adaption to various

stresses encountered in the body.

ACTIONS

MERSILENE mesh is a nonabsorbable mesh used to span and reinforce

traumatic or surgical wounds to provide extended support during and

following wound healing. Animal studies show that implantation of

MERSILENE mesh elicits a minimum to slight inflammatory reaction, which is

transient and is followed by the deposition of a thin fibrous layer of tissue

which can grow through the interstices of the mesh, thus incorporating the

mesh into adjacent tissue. The mesh remains soft and pliable, and normal

wound healing is not noticeably impaired. The material is not absorbed nor is

it subject to degradation or weakening by the action of tissue enzymes.

INDICATIONS

This mesh may be used for the repair of hernia and other fascial deficiencies

that require the addition of a reinforcing or bridging material to obtain the

desired surgical result.

CONTRAINDICATIONS

When this mesh is used in infants or children with future growth potential, the

surgeon should be aware that this product will not stretch significantly as the

patient grows.

MERSILENE polyester fiber mesh in contaminated wounds should be used

with the understanding that subsequent infection may require removal of

the material.

WARNINGS

MERSILENE mesh is provided by ETHICON, INC. as a sterile product. Unused

MERSILENE Mesh which has been removed from the package may be resteril-

ized not more than one time by a conventional stream autoclaving process

at conditions of 250˚F (121˚C) for 20 minutes. MERSILENE mesh may also be

flash autoclaved not more than one time at conditions of 270˚F (132˚C) for

10 minutes. Resterilization under any other conditions or by any other means

is neither recommended nor endorsed by ETHICON, INC.

If this product should become stained with blood or soiled, it should not be

resterilized for reuse.

PRECAUTIONS

A minimum of 6.5mm (1/4 inch) of mesh should extend beyond the suture line.

ADVERSE REACTIONS

No significant adverse clinical reactions to MERSILENE mesh have been

reported. The use of nonabsorbable MERSILENE mesh in a wound that is

contaminated or infected could lead to fistula formation and/or extrusion of

the mesh.

INDICATIONS FOR USE

It is recommended that nonabsorbable sutures be placed 6.5 to 12.5mm (1/4 to

1/2 inch) apart at a distance approximately 6.5mm (1/4 inch) from edge of the

mesh. Some surgeons prefer to suture and uncut section of mesh that is

considerably large than the defect into position over the wound. The opposite

sides are then sutured to assure proper closure under correct tension. When

the margin sutures have all been placed, the extra mesh is trimmed away.

HOW SUPPLIED

MERSILENE mesh is available in single packets as sterile, undyed (white)

sheets in two sizes. The sizes available are 6 x 11cm (2.5 x 4.5 inches) and 30

x 30cm (12 x 12 inches). Each sheet is 0.25mm (0.010 inch) thick.

CHAPTER 8 97

MONOCRYL* (Poliglecaprone 25)Suture

SYNTHETIC ABSORBABLE SUTURE,

U.S.P., EXCEPT FOR DIAMETER

DESCRIPTION

MONOCRYL* (poliglecaprone 25) suture is a monofilament synthetic

absorbable surgical suture prepared from a copolymer of glycolide and

epsilon-caprolactone. Poliglecaprone 25 copolymer has been found to be

nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during

absorption.

MONOCRYL sutures are U.S.P. except for diameters in the following sizes:

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.

U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm)

6-0 0.049

5-0 0.033

4-0 0.045

3-0 0.067

2-0 0.055

0 0.088

1 0.066

2 0.099

INDICATIONS

MONOCRYL sutures are indicated for use in general soft tissue approximation

and/or ligation, but not for use in cardiovascular or neurological tissues,

microsurgery or ophthalmic surgery.

ACTIONS

MONOCRYL suture is a monofilament which elicits a minimal acute inflamma-

tory reaction in tissues and ingrowth of fibrous connective tissue. Progressive

loss of tensile strength and eventual absorption of MONOCRYL sutures occurs

by means of hydrolysis. Absorption begins as a loss of tensile strength

followed by a loss of mass. Implantation studies in rats indicate that

MONOCRYL suture retains approximately 50 to 60% of its original strength

7 days post implantation, and approximately 20 to 30% of its original tensile

strength at 14 days post implantation. All of the original tensile strength is lost

by 21 days post implantation. The absolute strength remaining 14 days post

implantation meets or exceeds that historically observed with plain or chromic

surgical gut sutures. Absorption of MONOCRYL absorbable synthetic suture is

essentially complete between 91 and 119 days.

APPROXIMATE % ORIGINAL

DAYS IMPLANTATION STRENGTH REMAINING

7 DAYS 50 TO 60%

14 DAYS 20 TO 30%

CONTRAINDICATIONS

This suture, being absorbable, should not be used where extended approxi-

mation of tissue under stress is required, such as in fascia.

WARNINGS

Users should be familiar with surgical procedures and techniques involving

absorbable sutures before employing MONOCRYL suture for wound closure,

as risk of wound dehiscence may vary with the site of application and the

suture material used. Physicians should consider the in vivo performance

(under ACTIONS section) when selecting a suture for use in patients. The use

of this suture may be inappropriate in elderly, malnourished, or debilitated

patients, or in patients suffering from conditions which may delay wound

healing.

Do not resterilize. Discard opened packages and unused sutures.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus

formation. As an absorbable suture, MONOCRYL suture may act transiently as

a foreign body. Acceptable surgical practice should be followed for the

management of contaminated or infected wounds.

As this is an absorbable suture material, the use of supplemental

nonabsorbable sutures should be considered by the surgeon in the closure of

the sites which may undergo expansion, stretching or distention, or which may

require additional support.

PRECAUTIONS

Skin sutures which must remain in place longer than 7 days may cause local-

ized irritation and should be snipped off or removed as indicated. Subcuticular

sutures should be placed as deeply as possible to minimize the erythema and

induration normally associated with absorption.

Under some circumstances, notably orthopaedic procedures, immobilization of

joints by external support may be employed at the discretion of the surgeon.

Consideration should be taken in the use of absorbable sutures in tissue with

poor blood supply as suture extrusion and delayed absorption may occur.

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders.

MONOCRYL suture knots must be properly placed to be secure. Adequate knot

security requires the accepted surgical technique of flat and square ties with

additional throws as warranted by surgical circumstance and the experience of

the surgeon. The use of additional throws may be particularly appropriate

when knotting monofilaments.

Avoid prolonged exposure to elevated temperature.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to

the point. Reshaping needles may cause them to lose strength and be less

resistant to bending and breaking. Users should exercise caution when

handling surgical needles to avoid inadvertent needle sticks. Discard used

needles in "sharps" containers.

ADVERSE REACTIONS

Adverse effects associated with the use of synthetic absorbable sutures include

wound dehiscence, failure to provide adequate wound support in closure of the

sites where expansion, stretching, or distension occur, failure to provide ade-

quate wound support in elderly, malnourished or debilitated patients or in

patients suffering from conditions which may delay wound healing, infection,

minimal acute inflammatory tissue reaction, localized irritation when skin

sutures are left in place for greater than 7 days, suture extrusion and delayed

absorption in tissue with poor blood supply, calculi formation in urinary and

biliary tracts when prolonged contact with salt solutions such as urine and bile

occurs, and transitory local irritation at the wound site. Broken needles may

result in extended or additional surgeries or residual foreign bodies.

Inadvertent needle sticks with contaminated surgical needles may result in the

transmission of bloodborne pathogens.

HOW SUPPLIED

MONOCRYL sutures are available as sterile, monofilament, undyed (natural)

strands in sizes 6-0 through 2 (metric sizes 0.7-5), in a variety of lengths, with

or without needles.

MONOCRYL sutures are also available in sizes 3-0 through 1 (metricsizes 2-4)

attached to CONTROL RELEASE* removable needles.

MONOCRYL sutures are available in one and three dozen boxes.

PRODUCT INFORMATION

MONOCRYL* VIOLET MONOFILAMENT

(Poliglecaprone 25)Suture

SYNTHETIC ABSORBABLE SUTURE, U.S.P.,

EXCEPT FOR DIAMETER

DESCRIPTION

MONOCRYL* (poliglecaprone 25)suture is a monofilament synthetic

absorbable surgical suture prepared from a copolymer of glycolide and

epsilon-caprolactone. Poliglecaprone 25 copolymer has been found to be

nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during

absorption.

MONOCRYL sutures are U.S.P. except for diameters in the following sizes:

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.

U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm)

6-0 0.049

5-0 0.033

4-0 0.045

3-0 0.067

2-0 0.055

0 0.088

1 0.066

2 0.099

INDICATIONS

MONOCRYL sutures are indicated for use in general soft tissue approximation

and/or ligation, but not for use in cardiovascular or neurological tissues,

microsurgery or ophthalmic surgery.

ACTIONS

MONOCRYL suture is a monofilament which elicits a minimal acute inflamma-

tory reaction in tissues and ingrowth of fibrous connective tissue. Progressive

loss of tensile strength and eventual absorption of MONOCRYL sutures occurs

by means of hydrolysis. Absorption begins as a loss of tensile strength

followed by a loss of mass. Implantation studies in rats indicate that

MONOCRYL suture retains approximately 60 to 70% of its original strength

7 days post implantation, and approximately 30 to 40% of its original tensile

strength at 14 days post implantation. Essentially all of the original tensile

strength is lost by 28 days post implantation. Absorption of MONOCRYL

absorbable synthetic suture is essentially complete between 91 and 119 days.

APPROXIMATE % ORIGINAL

DAYS IMPLANTATION STRENGTH REMAINING

7 DAYS 60 TO 70%

14 DAYS 30 TO 40%

CONTRAINDICATIONS

This suture, being absorbable, should not be used where extended approxi-

mation of tissue under stress is required.

WARNINGS

Users should be familiar with surgical procedures and techniques involving

absorbable sutures before employing MONOCRYL suture for wound closure,

as risk of wound dehiscence may vary with the site of application and the

suture material used. Physicians should consider the in vivo performance

(under ACTIONS section) when selecting a suture for use in patients. The

use of this suture may be inappropriate in elderly, malnourished, or debilitated

patients, or in patients suffering from conditions which may delay wound

healing.

Do not resterilize. Discard opened packages and unused sutures.

As with any foreign body, prolonged contact of any suture with salt solutions,

such as those found in the urinary or biliary tracts, may result in calculus

formation. As an absorbable suture, MONOCRYL suture may act transiently as

a foreign body. Acceptable surgical practice should be followed for the

management of contaminated or infected wounds.

As this is an absorbable suture material, the use of supplemental

nonabsorbable sutures should be considered by the surgeon in the closure of

the sites which may undergo expansion, stretching or distention, or which may

require additional support.

PRECAUTIONS

Skin sutures which must remain in place longer than 7 days may cause local-

ized irritation and should be snipped off or removed as indicated. Subcuticular

sutures should be placed as deeply as possible to minimize the erythema and

induration normally associated with absorption.

Under some circumstances, notably orthopaedic procedures, immobilization of

joints by external support may be employed at the discretion of the surgeon.

Consideration should be taken in the use of absorbable sutures in tissue with

poor blood supply as suture extrusion and delayed absorption may occur.

In handling this or any other suture material, care should be taken to avoid

damage from handling. Avoid crushing or crimping damage due to application

of surgical instruments such as forceps or needle holders.

MONOCRYL suture knots must be properly placed to be secure. Adequate knot

security requires the accepted surgical technique of flat and square ties with

additional throws as warranted by surgical circumstance and the experience of

the surgeon. The use of additional throws may be particularly appropriate

when knotting monofilaments.

Avoid prolonged exposure to elevated temperature.

To avoid damaging needle points and swage areas, grasp the needle in an area

one-third (1/3) to one-half (1/2) of the distance from the swaged end to the

point. Reshaping needles may cause them to lose strength and be less

resistant to bending and breaking. Users should exercise caution when

handling surgical needles to avoid inadvertent needle sticks. Discard used

needles in "sharps" containers.

ADVERSE REACTIONS

Adverse effects associated with the use of synthetic absorbable sutures include

wound dehiscence, failure to provide adequate wound support in closure of the

sites where expansion, stretching, or distension occur, failure to provide

adequate wound support in elderly, malnourished or debilitated patients or in