Federal Register, Volume 63 Issue 116 (Wednesday, June 17, 1998)

[Federal Register Volume 63, Number 116 (Wednesday, June 17, 1998)]
[Notices]
[Pages 33168-33192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15551]

[[Page 33167]]

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Part III

Department of Health and Human Services

_______________________________________________________________________

Centers for Disease Control and Prevention

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Draft Guideline for the Prevention of Surgical Site Infection, 1998;
Notice

Federal Register / Vol. 63, No. 116 / Wednesday, June 17, 1998 /
Notices

[[Page 33168]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Draft Guideline for the Prevention of Surgical Site Infection,
1998

AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (DHHS).

ACTION: Notice.

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SUMMARY: This notice is a request for review of and comment on the
Draft Guideline for the Prevention of Surgical Site Infection, 1998.
The guideline consists of two parts: Part 1. ``Surgical Site Infection,
an Overview'' and Part 2. ``Recommendations for the Prevention of
Surgical Site Infections'', and was prepared by the Hospital Infection
Control Practices Advisory Committee (HICPAC), the Hospital Infection
Program (HIP), the National Center for Infectious Diseases (NCID), CDC.

DATES: Written comments on the draft document must be received on or
before August 17, 1998.

ADDRESSES: Comments on this document should be submitted in writing to
the CDC, Attention: SSI Guideline Information Center, Mailstop E-69,
1600 Clifton Road, N.E., Atlanta, Georgia 30333. To order copies of the
Federal Register containing the document, contact the U.S. Government
Printing Office, Order and Information Desk, Washington, DC 20402-9329,
telephone (202) 512-1800. In addition, the Federal Register containing
this draft document may be viewed and photocopied at most libraries
designated as U.S. Government Depository Libraries and at many other
public and academic libraries that receive the Federal Register
throughout the country. Addresses and telephone numbers of the U.S.
Government Depository Libraries are available by fax by calling U.S.
Fax Watch at (202) 512-1716 and selecting option 5 from the main menu.
The Federal Register is also available online at the Superintendent of
Documents home page at: http://www.access.gpo.gov/su__docs, or the
Hospital Infection Program Home page at: http://www.cdc.gov/ncidod/hip/
hip.htm

FOR FURTHER INFORMATION CONTACT: The CDC Fax Information Center,
telephone (888) 232-3299 and order document number 370160 or telephone
(888) 232-3228, then press 2, 2, 3, 2, 2, 1, 5 to go directly to the
guideline information.

SUPPLEMENTARY INFORMATION: This 2-part document updates and replaces
the previously published CDC Guideline for the Prevention of Surgical
Wound Infection. Part 1, ``Surgical Site Infection, an Overview''
serves as the background for the consensus recommendations of the
Hospital Infection Control Practices Advisory Committee (HICPAC) that
are contained in Part 2, ``Recommendations for Prevention of Surgical
Site Infections''.
HICPAC was established in 1991 to provide advice and guidance to
the Secretary and the Assistant Secretary for Health, DHHS; the
Director, CDC, and the Director, NCID regarding the practice of
hospital infection control and strategies for surveillance, prevention,
and control of nosocomial infections in U.S. hospitals. The committee
also advises CDC on periodic updating of guidelines and other policy
statements regarding prevention of nosocomial infections.
The Guideline for the Prevention of Surgical Site Infection, 1998
is the third in a series of CDC guidelines being revised by HICPAC and
NCID, CDC.

Dated: June 5, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).

Executive Summary

This ``Guideline for the Prevention of Surgical Site Infection,
1998'' represents the third revision of the Centers for Disease Control
and Prevention's (CDC) recommendations for the prevention of surgical
site infection (SSI), formerly called surgical wound infections. This
two-part guideline updates and replaces previous guidelines.\1\ \2\
Part I, ``Surgical Site Infection: An Overview,'' describes the
epidemiology, definitions, microbiology, pathogenesis, and surveillance
of SSIs. Part I also discusses SSI prevention measures such as
antimicrobial prophylaxis, barrier precautions, operating room
environment, sterilization practices, and surgical technique.
Recommended strategies for the prevention of SSIs are found in Part
II, ``Recommendations for the Prevention of Surgical Site Infection.''
These recommendations represent the consensus of the Hospital Infection
Control Practices Advisory Committee (HICPAC). This 12-member committee
advises CDC on issues related to surveillance, prevention, and control
of nosocomial infections in United States hospitals.\3\ Whenever
possible, the recommendations in Part II are based on data from well-
designed scientific studies. However, it must be kept in mind that a
limited number of studies establish the validation of SSI risk factors
and SSI prevention measures. By necessity, available studies have often
been conducted in narrowly defined patient populations or for specific
kinds of operations, making generalization of their findings to all
specialties and types of operations potentially problematic. This is
especially true regarding the implementation of SSI prevention
measures. Finally, some of the infection control practices routinely
used by surgical teams cannot be rigorously studied for ethical or
logistical reasons (e.g., wearing vs. not wearing gloves or masks).
Thus, some of the recommendations in Part II are based on a strong
theoretical rationale and suggestive evidence in the absence of
confirmatory scientific knowledge.
This document does not specifically address issues unique to burns,
trauma, transplant procedures, or transmission of bloodborne pathogens
from health-care worker to patient. Neither does it specifically cover
minimally invasive (e.g., laparoscopic) procedures
or procedures performed by surgeons outside of the operating room
(e.g., endoscopic procedures). This document does not cover invasive
procedures not performed by surgeons (e.g., cardiac catheterization, or
interventional radiologic procedures). However, it is likely that many
of the prevention strategies recommended in this document could be
applied or adapted to prevent infections that complicate these
procedures. The document does not recommend specific antiseptic agents
for patient preoperative skin preparations or for health-care worker
hand/forearm antisepsis. Hospitals should choose from the appropriate
products categorized by the Food and Drug Administration (FDA).\4\
Finally, this document is primarily intended for use in acute-care
hospitals by surgeons, operating room nurses, infection control
professionals, anesthesiologists, hospital epidemiologists, and other
hospital personnel responsible for the prevention of nosocomial
infections.
---------------------------------------------------------------------------

\\ Currently, for minimally invasive and laparoscopic
procedures no differences in infection control practices
(preoperative, intraoperative, or postoperative) have been
identified.
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Part I. Surgical Site Infection (SSI): An Overview

Introduction

Before the mid-19th century, surgical patients commonly developed
postoperative ``irritative fever,'' followed by purulent drainage from
their incisions, overwhelming sepsis, and often death. It was not until
the late 1860s, after Joseph Lister had introduced the principles of
antisepsis, that postoperative infectious morbidity

[[Page 33169]]

decreased substantially. Lister's work radically changed surgery from
an activity associated with infection and death to a discipline that
could eliminate suffering and prolong life.
Currently, in the United States alone, an estimated 27 million
surgical procedures are performed each year, and nearly one-third of
patients undergoing these operations are 65 years of age.\5\
The CDC's National Nosocomial Infections Surveillance (NNIS) system,
established in 1970, monitors reported trends in nosocomial infections
in U.S. acute-care hospitals. Based on NNIS system reports, SSIs are
the second most frequently reported nosocomial infection, accounting
for 15% to 18% of all nosocomial infections among hospitalized
patients.\6\ During 1986-1996, hospitals conducting SSI surveillance in
the NNIS system reported 15,523 SSIs following 593,344 operations.
Among surgical patients, SSIs were the most common nosocomial
infection, accounting for 38% of all nosocomial infections. Of these
SSIs, 67% were incisional and 33% organ/space SSIs. Of the deaths among
surgical patients with an SSI, 77% were related to the infection
itself; the majority (93%) were organ/space SSIs. In 1980, Cruse showed
that an SSI increased a patient's hospital stay by about 10 days, and
cost an additional $2,000.\7\ \8\ 1992 estimates suggested that each
SSI resulted in 7.3 additional postoperative hospital days, adding
$3,152 in extra charges.\9\ Other studies corroborate that increased
length of hospital stay and cost are associated with SSIs.\10\ \11\
Deep (organ/space) SSIs, as compared to superficial (incisional) SSIs,
are associated with an even greater increase in hospital cost.\12\ \13\
In this document, SSIs refer to infections of incisions that are
closed primarily (i.e., skin edges are re-approximated at the end of
the operation). SSIs are classified as incisional SSIs or organ/space
SSIs. Incisional SSIs are further divided into those involving only
skin and subcutaneous tissue (superficial incisional SSI) and those
involving deeper soft tissues of the incision (deep incisional SSI).
Organ/space SSIs involve any part of the anatomy (e.g., organs or
spaces) other than incised body wall layers opened or manipulated
during operations (Figure 1). Standardized criteria have been developed
for defining superficial incisional, deep incisional, and organ/space
SSIs are shown in Table 1. Table 2 lists specific sites used to
differentiate organ/space SSIs. For example, in a patient who had an
appendectomy and subsequently developed a subdiaphragmatic abscess, the
infection would be reported as an organ/space SSI at the intra-
abdominal specific site. Failure to use objective criteria to define
SSIs has been shown to substantially impact SSI rates.\14\ \15\ The CDC
NNIS definitions of SSIs have been applied consistently by surveillance
and surgical personnel in many settings and currently are a de facto
national standard.\16\ \17\
Advances in infection control practices include improved operating
room ventilation, sterilization, barriers, surgical technique, and
availability of antimicrobial prophylaxis. Despite these activities,
SSIs remain a substantial cause of morbidity and mortality among
hospitalized patients. In part, this may be explained by the fact that
many surgical patients today are of advanced age and/or have a wide
variety of chronic, debilitating or immunocompromising underlying
diseases. An increase in survival of low-birth-weight infants (e.g.,
1000 g) may pose unique surgical challenges. There also are
increased numbers of implants used and more organ transplants
performed. Other factors include emergence of resistant pathogens,
increased numbers of contaminated and dirty procedures (e.g., trauma-
associated gunshot wounds and motor vehicle accidents). Thus, to reduce
the risk of an SSI, a systematic but realistic approach must be applied
with the awareness that this risk is influenced by characteristics of
the hospital, surgical team, patient, and operation.

Microbiology of SSIs

According to the NNIS system the distribution of pathogens isolated
from SSIs has not changed markedly during the last decade (Table
3).⁶ ¹⁸ \19\ Staphylococcus aureus, coagulase-
negative staphylococci, Enterococcus spp., and Escherichia coli remain
the most frequently isolated pathogens. However, SSIs are increasingly
caused by antimicrobial-resistant pathogens, such as methicillin-
resistant S. aureus (MRSA), vancomycin-resistant enterococcus, and gram
negative rods.²⁰ \21\ In one 4-year study of 245 consecutive
SSIs, 50% of all staphylococcal isolates were MRSA, 11% were
gentamicin-resistant E. coli, and Klebsiella spp. demonstrated an
increased resistance to aminoglycosides.\22\
The isolation of fungi from SSI, particularly Candida albicans,
also has increased.\23\ From 1991-1995, among patients at NNIS
hospitals, the incidence of fungal SSIs increased from 0.1 to 0.3 per
1000 discharges.\23\ The increased proportion of SSIs caused by
resistant pathogens and Candida spp. may reflect an increased severity
of illness of surgical patients, an increased number of surgical
patients who are immunocompromised, and/or more widespread use of
prophylactic and therapeutic antimicrobial agents.
Outbreaks or clusters of SSIs have also been caused by unusual
pathogens, such as Rhizopus oryzae, Clostridium perfringens,
Rhodococcus bronchialis, Legionella pneumophila and dumoffii, and
Pseudomonas multivorans. These rare outbreaks have been traced to
contaminated adhesive dressings,\24\ elastic bandages,\25\ colonized
health care personnel,\26\ tap water,\27\ or contaminated disinfection
solution.\28\ When a cluster of SSIs is caused by an unusual pathogen,
a formal epidemiologic investigation should be conducted to determine
the source of infection.

Pathogenesis of SSI

Microbial contamination of the surgical site is a necessary
precursor of SSI. The risk of SSI can be conceptualized according to
the following relationship \29\:
[GRAPHIC] [TIFF OMITTED] TN17JN98.000

Quantitatively, it has been shown that if a surgical site is
contaminated with >10 \5\ microorganisms per gram of tissue, the risk
of SSI is markedly increased, whereas contamination with <10 \5\
microorganisms per gram of tissue usually does not produce
infection.^30-32 The risk of SSI is increased when foreign
material, such as sutures,\33\ indwelling devices, or prostheses are
placed. For example, researchers have shown that the insertion of
foreign material can decrease the infecting dose of staphylococci from
>10 \6\ to <10 \3\ microorganisms per gram of tissue.^34-36
Organisms may contain or produce substances or toxins that increase
their ability to invade a host, produce damage

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within the host, or survive on or in colonized or infected host tissue;
promoting the development of an SSI.^37-40 For example,
endotoxin has numerous effects as a component of the outer membrane of
gram negative bacteria, such as a stimulator of cytokine production,
and as an initiator of endogenous mediator pathways with significant
systemic effects (e.g., hypotension, fever).⁴¹ \42\ Some
bacterial surface components (notably polysaccharide extracellular
capsules) inhibit phagocytosis.\43\ Some bacteria, such as Clostridium
spp., produce powerful cytolytic exotoxins that disrupt cell membranes
or alter cellular metabolism.³² \44\ Glycocalyx and the more
loosely associated component, ``slime'', are produced by a variety of
microorganisms, of particular significance gram-positive bacteria, and
most notably coagulase negative staphylococci.^45-47 The
glycocalyx material slime develops into a biofilm and can shield
infecting bacteria from phagocytosis, as well as inhibit the action of
antimicrobial agents.\47\ Glycocalyx biofilms have been implicated as a
significant contributor to infection of surgically implanted
prostheses.^47-52 Despite knowledge of these and other
virulence factors, in most cases the mechanistic relationship between
their presence and SSI development has not yet been fully defined.
The primary reservoir for organisms causing SSI is the patient's
endogenous flora. Exogenous sources of SSI pathogens include the
operating room environment, hospital personnel (especially those in the
operating room),^53-55 or seeding of the operative site from
a distant focus of infection.^56-60 Seeding from distant foci
is particularly important in patients who have prostheses or other
implants placed during the operation since the device provides a nidus
for attachment of the organism.^61-66 The endogenous flora
causing SSIs vary according to the specific body
site.^{19 67-71} For example, an SSI arising from the skin is
predominant due to gram-positive organisms (e.g., staphylococci). SSIs
arising from the gastrointestinal system are composed of a more mixed
group of organisms, including enteric, gram-negative bacilli (e.g., E.
coli), anaerobes (e.g., B. fragilis), and gram-positive organisms
(staphylococci and enterococci). SSIs arising from the genitourinary
system are predominantly due to gram-negative organisms (e.g., E. coli,
Klebsiella spp., and Pseudomonas), and enterococci. The organisms
causing SSIs in the female reproductive system include enteric, gram-
negative bacilli; enterococci; group B streptococci; and anaerobes.
Exogenous flora are primarily gram-positive organisms (e.g.,
staphylococci and streptococci) and other aerobes.\19\
Fungal pathogens rarely cause SSIs, and their pathogenesis is not
well understood. Factors that increase the risk of fungal infections in
surgical patients include (1) fungal colonization of the upper
gastrointestinal tract following exposure to broad-spectrum
antimicrobials, (2) use of proton pump inhibitors or histamine-2
blockers that decrease stomach acidity and promote growth of
microorganisms, including yeast, (3) disruption of the gastrointestinal
mucosal barrier, (4) impaired host defenses,\53\ (5) implantation of
foreign bodies (e.g., prosthetic heart valves), and (6) colonized
operating room personnel (e.g., fungal colonization of artificial
nails).\72\

Risk and Prevention of SSIs

The term ``risk factor'' has a particular meaning in epidemiology
and, in the context of SSI pathophysiology and prevention, strictly
refers to a variable that has a significant, independent association
with the development of SSIs. Risk factors are identified by
multivariable analyses in epidemiologic studies. Unfortunately, the
term risk factor often is used in the literature in a broad sense to
include patient or operation features which, although associated with
SSI development, are not themselves independent.\73\ The literature
cited in the sections that follow includes both the strict and broad
definition of risk factor. Recommendations given a category ranking of
IA are generally based on studies using the strict definition.
SSI risk factors (Table 4) are valuable in two ways: (1) they allow
useful stratification of operations, making surveillance data more
comprehensible, and (2) preoperative knowledge of risk factors may
allow for targeted prevention interventions. For example, it is known
that remote site infection is an independent SSI risk factor in some
operations. If a patient has such an infection, the surgical team may
choose to delay an elective operation until the infection resolves.
An SSI prevention measure can be defined as an action or set of
actions intentionally taken by caregivers to reduce the risk of an SSI.
Many such techniques, to be described subsequently, involve reducing
the opportunities for microbial contamination of the patient's tissues
or sterile surgical instruments. Other techniques are adjunctive, such
as using antimicrobial prophylaxis or avoiding unnecessary traumatic
tissue dissection. In general, SSI prevention measures have been based
on direct scientific evidence, theoretical rationale, or tradition. In
the discussion that follows, the foundation for each given prevention
measure will be described. Optimum application of SSI prevention
measures requires that a variety of patient and operation
characteristics be carefully considered.
In certain kinds of operations, patient characteristics that may be
associated with an increased risk of an SSI include coincident remote
site infections (e.g., urinary tract, skin, or respiratory
tract),^{1 31 74-76} diabetes,^77-80 cigarette
smoking,^{78 81-85} systemic steroid use,^{77 80 86}
obesity (> 20% ideal body weight),^{78-80 87-90} extremes of
age,^{85 91-95} and poor nutritional
status.^{78 87 91 96-98}
The contribution of diabetes to SSI risk is controversial
^{77-79 91 99} because the independent contribution of diabetes
to SSI risk has not typically been assessed after controlling for
potential confounding factors. In one prospective study of 130 pregnant
women, no correlation was found between SSI risk and perioperative
glycemic control, as measured by glycosylated hemoglobin (HgA1c)
levels. However, the sample size in the study was small and the use of
prophylactic antimicrobial agents was not assessed. More recently, the
relationship between HgA1c levels and SSI risk in coronary artery
bypass graft patients was assessed; a significant relationship was
found between increasing levels of HbA1c and SSI rates.¹⁰⁰
Also, increased glucose levels (>200 mg/dl) in the immediate
postoperative period (48 hours) were associated with
increased SSI risk.^{101 102} More studies are needed to assess
the efficacy of perioperative blood glucose control as an adjunctive
measure.
Nicotine use delays primary wound healing and may increase the risk
of SSI.⁷⁸ In a large prospective study, current cigarette
smoking was an independent risk factor for sternal and/or mediastinal
SSI following cardiac surgery.⁷⁸ Other studies have
corroborated cigarette smoking as an important SSI risk
factor.^81-85 The limitation of these studies, however, is
that terms like ``current cigarette smoking'' and ``active smokers''
are not always accurately defined. To appropriately determine the
contribution of tobacco use to SSI risk, standardized definitions of
smoking history must be adopted and used in studies designed to control
for confounding variables.

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Patients who are receiving steroids or other immunosuppressive
drugs preoperatively also may be predisposed to developing
SSI.^{77 80} In a study of long-term steroid use in patients
with Crohn's disease, SSI developed significantly more often in
patients receiving preoperative steroids (12.5%) than in patients
without steroid use (6.7%).⁸⁶ In contrast, other
investigators have not found a relationship between steroid use and SSI
risk.^103-105
There may be an increased risk of SSI in patients who are
malnourished, but the exact relationship between nutritional status and
risk of SSI is unclear. Low serum albumin (<3.5 g/dl) has been shown to
be associated with an increased risk of SSI.^{78 96-98} More
precise definitions of malnutrition are needed, along with prospective
observational studies, to resolve this issue.
Prolonged preoperative hospital stay is frequently suggested as a
patient characteristic associated with increased SSI risk. However,
length of preoperative stay is likely a surrogate for severity of
illness and co-morbid conditions requiring inpatient work-up and /or
therapy before the operation.^{8 18 19 75 93 104 106 107}

Preoperative Issues

Preoperative Antiseptic Showers
A preoperative antiseptic shower or bath will decrease the
patient's skin microbial colony count. In a study of >700 patients who
received preoperative antiseptic showers, chlorhexidine reduced
bacterial colony counts nine-fold (2.8 x 10² to 0.3),
while povidone-iodine or triclocarban-medicated soap reduced colony
counts by 1.3 and 1.9-fold, respectively.¹⁰⁸ A smaller
uncontrolled study corroborated these findings.¹⁰⁹ Despite
the fact that preoperative showers reduce the skin's microbial colony
counts, it has not definitively been shown to reduce SSI
rates.^110-112
Preoperative Shaving/Hair Removal
Preoperative shaving of the surgical site the night before an
operation is associated with a significantly higher SSI risk. This risk
is greater than that accompanying the use of depilatory agents or no
hair removal.^{8 113-115} In one study, SSI rates were 5.6% in
patients who had hair removed by razor-shave compared to a 0.6% rate
among those who had hair removed by depilatory or had no hair
removal.¹¹³ The increased SSI risk associated with shaving
has been attributed to microscopic cuts in the skin that later serve as
foci for infection. Shaving immediately before the operation compared
to shaving within 24 hours or > 24 hours preoperatively is associated
with decreased SSI rates (3.1% vs. 7.1% and 20%
respectively).¹¹³ Clipping hair immediately before an
operation is also associated with a lower risk of SSI than shaving or
clipping the night before an operation (SSI rates immediately before =
1.8% vs night before = 4.0%).^116-119 Although the use of
depilatories is associated with a lower SSI risk than shaving or
clipping,^{113 114} depilatories sometimes produce
hypersensitivity reactions.¹¹³ Other studies show that
preoperative hair removal is associated with increased SSI rates and
suggest that no hair be removed.^{93 120 121}
Patient Skin Preparation in the Operating Room
Several antiseptic agents are available for preoperative
preparation of skin at the incision site (Table 5). The iodophors
(e.g., povidone-iodine), alcohol-containing products, and chlorhexidine
gluconate are the most commonly used agents.^{18 31 122} No
studies have adequately assessed the comparative effects of these
preoperative skin antiseptics on SSI risk in well-controlled procedure-
specific studies.
Alcohol is defined by the Food and Drug Administration as having
one of the following active ingredients: ethyl alcohol 60-95% by volume
in an aqueous solution, or isopropyl alcohol 503-91.3% by volume in an
aqueous solution.\4\ In this document, -propyl alcohol is included in
the definition of alcohol. Alcohol is readily available, inexpensive,
and remains the most effective and rapid acting skin
antiseptic.¹²³ Aqueous 70%-92% alcohol solutions have
germicidal activity against bacteria, fungi, and viruses, but spores
can be resistant.^{123 124} One potential disadvantage of the
use of alcohol in the operating room is its
flammability.^123-125
Both chlorhexidine gluconate and iodophors have broad spectra of
antimicrobial activity.^{18 31 124 126} In some comparisons of
the two antiseptics, chlorhexidine gluconate achieved greater reduction
in skin microflora than did povidone-iodine and also had greater
residual activity after a single application.^127-129
Further, chlorhexidine gluconate is not inactivated by blood or serum
proteins.^{18 123 130 131} Iodophors may be inactivated by
blood or serum proteins, but exert a bacteriostatic effect as long as
they are present on the skin.^{18 125}
Before the skin preparation of a patient is initiated, the skin
should be free of gross contamination (i.e., dirt, soil, or any other
debris).¹³² The patients skin is prepped by applying an
antiseptic preparation in concentric circles, beginning in the area of
the proposed incision. The prepped area should be large enough to
extend the incision or create new incisions or drain sites, if
necessary.^{1 124 133} The application of the skin preparation
may need to be modified, depending on the condition of the skin (e.g.,
burns) or location of the incision site (e.g., face).
Some modifications of the preoperative skin preparation process
include: (1) removing, drying, or wiping off the skin prep antiseptic
agent after application, (2) using an antiseptic-impregnated adhesive
drape, (3) painting the skin with an antiseptic in lieu of the
traditional scrub, or (4) using a ``clean'' versus a ``sterile''
surgical skin prep kit. None of these modifications adds to further
reductions in bacterial colony counts at the surgical site or reduces
SSI risk.^{134 -137}
Preoperative Hand/Forearm Antisepsis
Members of the surgical team universally wash their hands and
forearms by performing a traditional procedure known as scrubbing (or
the surgical scrub) immediately before donning sterile gowns and
gloves. Ideally, the optimum antiseptic agent should have a broad
spectrum of activity, be fast-acting, and have a persistent
effect.^{1 138 139} Antiseptic agents commercially available in
the United States contain alcohol, chlorhexidine, iodine/iodophors,
para-chloro-meta-xylenol, or triclosan (Table
5).^{18 123 124 140 141} Alcohol is considered the ``gold
standard'' for surgical hand preparation in several European
countries.^142-145 Alcohol-containing preps have been used
less frequently in the United States than in Europe, possibly because
of concerns about flammability and skin irritation. Povidone-iodine and
chlorhexidine gluconate are the current agents of choice for most U.S.
surgical team members.¹²⁴ However, when 7.5% povidone-iodine
or 4% chlorhexidine gluconate was compared to alcoholic chlorhexidine
(60% isopropanol and 0.5% chlorhexidine gluconate in 70% isopropanol),
alcoholic chlorhexidine was found to have greater residual
antimicrobial activity.^{138 146} No agent is ideal for every
situation, and a major factor aside from the efficacy of any product is
its acceptability by operating room personnel after repeated usage.
Unfortunately, most studies evaluating surgical scrub antiseptics have
focused on measuring hand bacterial colony counts. No clinical trials
have evaluated

[[Page 33172]]

the impact of scrub agent choice on SSI risk.^{141 147-151}
Factors other than the choice of antiseptic agent influence the
effectiveness of the surgical scrub. Scrubbing technique, the duration
of the scrub, the condition of the hands, or the techniques used for
drying and gloving are examples of such factors. The ideal duration of
scrubbing is unknown. Recent studies suggest that scrub times of 3-5
minutes are as effective as the traditional 10-minute scrub in reducing
hand bacterial colony counts.^{152 153}
A surgical team member who wears artificial nails may have
increased hand bacterial and fungal colonization even after performing
an adequate hand scrub.^{154 155} Hand carriage of gram-
negative organisms has been shown to be greater among wearers of
artificial nails than among non-wearers.¹⁵⁵ An outbreak of
Serratia marcescens SSIs in cardiovascular surgery patients was found
to be associated with a surgical nurse who wore artificial
nails.⁷² Long nails, artificial or natural, may be
associated with tears in gloves.^{31 124 154} The influence on
SSI risk of operating room team members wearing nail polish or jewelry
has not been adequately studied.^{140 154 156-158}
Antimicrobial Prophylaxis
Well-designed, randomized clinical trials have demonstrated the
benefit of antimicrobial prophylaxis in certain kinds of
operations.^{12 70 159-195} Prophylaxis should not be confused
with therapy. Prophylaxis is the administration of an antimicrobial
agent for operations where minimal microbial contamination of the
surgical site is expected (i.e., clean or clean-contaminated
operations, Table 6).⁴⁷ Therapy is the administration of an
antimicrobial agent in operations where substantial microbial
contamination already has occurred (i.e., contaminated or dirty
operations).^{47 196 197} For prophylaxis to be maximally
effective, an appropriate agent must be administered at the correct
time to ensure microbiocidal tissue levels before the incision is made,
be maintained at adequate levels for the duration of the operation, and
not be continued postoperatively.^{69-71 198-200} There is no
evidence that antimicrobial agents given after incision closure have
prophylactic effect on bacterial contamination acquired before incision
closure.⁴⁷ Also, use of antimicrobial prophylaxis beyond the
intraoperative period may increase the risk of toxicity and the
development of antimicrobial-resistant organisms.^{47 71 201}
Antimicrobial prophylaxis is reserved for clean and clean-
contaminated operations. The purpose of antimicrobial prophylaxis in
clean operations in which prostheses, grafts, or implants are placed in
the patient is to prevent the attachment of organisms to the device
since the device can serve as a nidus for infection.\47\ \69\ \197\
\202\ \203\ In clean operations in which no implant or device is
placed, there is controversy regarding the use of antimicrobial
prophylaxis. Because the risk of developing an SSI following clean
operations is generally low,\87\ the risk of infection versus the risk
of prophylaxis must be considered. The purpose of using antimicrobial
prophylaxis in clean-contaminated operations is primarily to reduce the
number of mucosal-associated organisms.\71\ \202\
A prophylactic antimicrobial agent should be chosen based on its
efficacy against the SSI pathogens expected as contaminants for a
particular operation. Table 6 lists clean and clean-contaminated
operations and the most frequently isolated SSI pathogens. The most
commonly used agents are cephalosporins, particularly first and second
generation cephalosporins.\202\ Vancomycin should not be used routinely
as a prophylactic agent \69\ \70\ \197\ \204\ However, at institutions
with high numbers of infections due to (MRSA) or methicillin-resistant
Staphylococcus epidermidis, vancomycin has been recommended as a
prophylactic agent in major operations involving implantation of
prosthetic materials or devices (e.g., cardiac, vascular and orthopedic
operations).\69\ \204\ \205\
Intravenous administration of the prophylactic antimicrobial agent
is the most commonly used route. The intravenous route produces
adequate serum and tissue concentrations in a relatively short period
of time.\202\ A major exception to using the intravenous route is with
operations involving the gastrointestinal tract, mainly colorectal
operations.^{71 181 182 184 202 206-213} In these operations,
the antimicrobial agent is administered orally to reduce endogenous
flora in the gastrointestinal tract .
Timing and duration of prophylaxis are very important issues. The
objective is to administer the antimicrobial agent before the operation
starts to assure adequate microbiocidal tissue levels before the skin
incision is made. A large, prospective study of antimicrobial
prophylaxis in surgical patients undergoing elective clean and clean-
contaminated operations showed that when prophylaxis was given 0-2
hours before incision, the SSI rate was 0.59% (10/1708). If given
earlier or later, the SSI rate increased (3.8 % [14/369] and 3.3% [16/
488], respectively).\214\ For a cesarean section, the prophylactic
agent is given immediately after umbilical cord clamping to prevent the
infant from being exposed to the agent.\69\ \70\
In modern surgical practice, the optimum strategy for most commonly
used agents (first and second generation cephalosporins) entails
infusion of the preoperative dose approximately 30 minutes before skin
incision and administration of additional doses approximately every 2
hours intraoperatively.\18\ \69\ \71\ \197\ \202\ \203\ Because an
elective operation can be unexpectedly delayed, the practice of
administering prophylactic agents ``on call'' to the operating room is
not recommended.\70\ \215\ Appropriate timing of prophylaxis may be
enhanced by administering the agent as close as possible to the time of
anesthetic induction. In general, the duration of an operation will
dictate the necessity infusing one or more additional doses of the
prophylactic agent to maintain appropriate tissue levels (i.e., for
operations whose duration exceeds the estimated serum half-life). Other
reasons for additional intraoperative dosing include operations with
major intraoperative blood loss or operations on morbidly obese
patients.^{47 69 71 201 203 216-218}

Intraoperative Issues

Operating Room Environment

Air/Ventilation

Operating room air may contain microbial-laden dust, lint, skin
squames, or respiratory droplets. The microbial level in operating room
air is directly proportional to the number of people moving about in
the room.\219\ Therefore, efforts should be made to minimize personnel
traffic during operations. Outbreaks of SSIs caused by group A beta-
hemolytic streptococci have been traced to airborne transmission of the
organism from colonized operating room personnel to
patients.^220-223 In these outbreaks, the strain causing the
outbreak was recovered from the air in the operating room,\220\ \221\
\224\ or on settle plates in a room in which the human carrier
exercised.^221-223
Operating rooms should be maintained at positive pressure with
respect to corridors and adjacent areas.\225\ Positive pressure
prevents air flow from less clean areas into clean areas. All
ventilation or air conditioning systems in hospitals, including those
in operating rooms, should have two filter beds in series with the
efficiency of filter bed one ``30% and filter bed two

[[Page 33173]]

2'' 90%.\226\ Conventional operating room ventilation systems produce a
minimum of about 15 air changes of filtered air per hour. Three (20%)
of these air changes/hour must be fresh air.\226\ \227\ Air should be
introduced at the ceiling and exhausted near the floor.\227\ \228\
Recommended ventilation parameters for operating rooms have been
published by the American Institute of Architects, and the U.S.
Department of Health and Human Service (Table 7).\226\
Laminar air flow is designed to move particle-free air (called
``ultraclean air'') over the aseptic operating field at a uniform
velocity (0.3 to 0.5 m/sec), sweeping away particles in its
path. This air flow can be directed vertically or horizontally, and
recirculated air is usually passed through a high efficiency
particulate air (HEPA) filter.\229\ \230\ HEPA filters, commonly used
in hospitals, remove particles 0.3m in diameter with an
efficiency of 99.97%.\74\ \227\ \229\ \231\ Ultraviolet (UV) light has
been used as an infection control measure to reduce SSI risk. However,
neither laminar flow nor UV light has been conclusively shown to
decrease overall SSI risk.^{87 225 232-237}

Environmental Surfaces

Environmental surfaces in U.S. operating rooms (e.g., tables,
floors, walls, ceilings, lights, and the like) are rarely implicated as
the sources of pathogens important in the development of SSIs.
Nevertheless, it is important to perform routine cleaning of
environmental surfaces to reestablish a clean environment after each
operation.\31\ \154\ \227\ \229\ There are no data to support routine
disinfecting of environmental surfaces or equipment between operations
in the absence of contamination or visible soiling. When visible
soiling of surfaces or equipment occurs during an operation, an
Environmental Protection Agency (EPA)-approved hospital disinfectant
should be used to decontaminate the affected areas before the next
operation.^{31 154 227 229 238-240} This is in keeping with the
Occupational Safety and Health Administration (OSHA) requirement that
all equipment and environmental surfaces be cleaned and decontaminated
after contact with blood or other potentially infectious
materials.\240\ Wet-vacuuming with an EPA-approved hospital
disinfectant is performed routinely after the last operation of the day
or night. Care should be taken to insure that medical equipment is
covered and that solutions used for cleaning and disinfecting do not
contact sterile devices or equipment. There are no data to support
special cleaning procedures or closing an operating room after a
contaminated or dirty operation has been performed.\227\ \228\
Tacky mats placed outside the entrance to an operating room/suite
have not been shown to reduce the number of organisms on shoes or
stretcher wheels, nor do they reduce the risk of SSI.\1\ \18\ \219\
\228\

Microbiologic Sampling

Because there are no standards or acceptable parameters for
comparison of microbial levels for ambient air or environmental
surfaces in the operating room, routine microbiologic sampling cannot
be justified. Such environmental sampling should only be performed as
part of an epidemiologic investigation.

Conventional Sterilization of Surgical Instruments

Inadequate sterilization of surgical instruments has resulted in
SSI outbreaks.\229\ \241\ \242\ Surgical instruments can be sterilized
by steam under pressure, by dry heat, by ethylene oxide, or other
approved methods. The importance of monitoring the quality of
sterilization procedures has been established.\1\ \31\ \154\ \226\
Microbial monitoring of steam autoclaves performance is necessary and
can be accomplished by use of a biological indicator.\154\ \239\ \243\
Detailed recommendations for sterilization of surgical instruments have
been published.\154\ \239\ \244\ \245\

Flash Sterilization of Surgical Instruments

The Association for the Advancement of Medical Instruments (AAMI)
defines flash sterilization as ``the process designated for the steam
sterilization of patient care items for immediate use''.\245\ During
any operation, the need for emergency sterilization of equipment may
arise (e.g., to reprocess an inadvertently dropped instrument). Flash
sterilization is intended to be used for emergent sterilization of
surgical instruments and other items and is never used for reasons of
convenience such as an alternative to purchasing additional instrument
sets and as a general time-saver. Some of the reasons that flash
sterilization has not been recommended as a routine sterilization
method include lack of timely biologic indicators to monitor
performance, absence of protective packaging following sterilization,
possible contamination during transportation to the operating rooms,
and use of minimal cycle parameters (i.e., time, temperature,
pressure).\243\ The AAMI has published sterilization cycle parameters
for flash sterilization (Table 8).
Until studies are performed to demonstrate that routine flashing
for purposes other than emergencies does not increase SSI risk, flash
sterilization should be restricted to its intended purpose. Also, flash
sterilization is not recommended for implantable
devices because of the potential for serious
infections.\239\ \244\^-\246\
---------------------------------------------------------------------------

According to the FDA, an implantable device is
a ``device that is placed into a surgically or naturally formed
cavity of the human body if it is intended to remain there for a
period of 30 days or more''.\245\
---------------------------------------------------------------------------

Surgical Attire and Drapes

In this section the term ``surgical attire'' refers to scrub suits,
caps/hoods, shoe covers, masks, gloves, and gowns. Although
experimental data show that live microorganisms are shed from hair,
exposed skin, and mucous membranes of operating room personnel,\126\
\247\^-\252\ few controlled clinical studies have evaluated
the relationship between the use of surgical attire and the risk of
SSI. Nevertheless, the use of barriers seems prudent to minimize
exposure of a patient to the skin, mucous membranes, or hair of
surgical team members and operating room personnel, and to protect
operating room personnel from bloodborne pathogens (e.g., human
immunodeficiency virus and hepatitis virus).

Scrub Suits

Hospital personnel, especially operating room nurses, surgeons, and
anesthesiologists, often wear a uniform throughout the day that
consists of pants and top/shirt and is called a ``scrub suit.''
Procedures for laundering, wearing, covering, and changing scrub suits
vary greatly. In some facilities, scrub suits are laundered only by the
hospital, while in others, scrub suits also may be laundered at the
health-care worker's home. Although, there are no well-controlled
studies evaluating SSIs risk among hospital-versus home-laundered scrub
suits,\253\ the Association of Operating Room Nurses (AORN) recommend
scrub suits only be laundered in an approved and monitored laundry
facility.\154\ Some facilities require that scrub suits be worn only in
operating room suites, while others allow the wearing of cover gowns
over scrub suits when personnel leave the operating room suites. AORN
recommends changing scrub suits when they are visibly soiled.\154\ OSHA
requires that ``if a garment(s) is penetrated by blood or other
potentially infectious materials, the garment(s) shall

[[Page 33174]]

be removed immediately or as soon as feasible.'' \240\

Masks

Data regarding the possible effect of using surgical masks on SSI
risk are limited. However, there is a strong theoretical rationale for
wearing surgical masks during all operations. Some studies have
evaluated the efficacy of surgical masks in reducing SSI risk and have
raised issues regarding cost vs benefit.\254\-\258\ Although surgical
masks are effective at filtering out some bacteria, they may not
completely prevent passage of organisms around the sides and edges of
the mask.\250\, \259\, \260\ Nevertheless, masks protect the surgical
team from inadvertent exposures to blood (i.e., splashes) and other
body fluids. OSHA requires that masks in combination with eye
protection devices, such as goggles or glasses with solid shields, or
chin-length face shields be worn whenever splashes, spray, spatter, or
droplets of blood or other potentially infectious material may be
generated and eye, nose, or mouth contamination can be reasonably
anticipated.\240\

Surgical Caps/Hoods and Shoe Covers

Surgical caps/hoods are inexpensive and reduce the shedding of hair
and scalp organisms. Rarely, SSI outbreaks have been traced to
organisms isolated from the hair or scalp (S. aureus and Group A
Streptococcus),\248\ \261\ even when caps were worn by personnel during
the operation and in the operating suites.
The use of shoe covers has never been shown to decrease SSI risk or
decrease floor bacterial counts.\262\ \263\ Shoe covers may protect a
health care worker from exposures to blood and other body fluids during
an operation. OSHA stipulates that surgical caps or hoods and/or shoe
covers or boots shall be worn in instances when gross contamination can
reasonably be anticipated (e.g., autopsies, orthopaedic surgery).\240\

Sterile Gloves

There is a strong theoretical rationale for the use of sterile
gloves by all members of the surgical team. Sterile gloves are worn to
minimize transmission of microorganisms from the hands of operating
room personnel to patient's and to prevent contamination of personnel
hands with blood and body fluids. If the integrity of a glove is
compromised (e.g., punctured) it should be changed as promptly as
safety permits.^{240 264-266} Double gloving (i.e., wearing two
pairs of gloves) has been shown to reduce bloodborne pathogen
contamination of surgical team members' hands.^267-270
Sterile gloves are put on after donning sterile gowns.

Gowns and Drapes

Both sterile surgical gowns and drapes are used to create an
aseptic barrier between the surgical site incision and possible sources
of bacteria. Gowns are worn by operating room personnel and drapes are
laid over the patient. There are limited data to substantiate the
impact of surgical gowns and drapes on reducing SSI risk. The wide
variation in the products studied and the study designs make available
data difficult to evaluate.^{251 271-275}
Gowns and drapes are classified as disposable (single use) or
reusable (multiple use). Regardless of the material used to manufacture
gowns and drapes, these items should be impermeable to liquids and
viruses ^{276 277} and effective when wet.¹ In
general, only gowns reinforced with films, coatings, or membranes
appear to meet standards developed by the American Society for Testing
and Material (ASTM).^276-278 However, the gowns that do meet
these standards ``liquid proof'' gowns may be uncomfortable because
they also inhibit the evaporation of sweat and heat loss from the
wearer's body. These factors should be considered when selecting
gowns.²⁷⁸

Practice of Anesthesiology

Anesthesiologists and nurse anesthetists perform invasive
procedures (e.g., placement of intravascular devices, endotracheal
intubation, administering intravenous solutions) and work in close
proximity to sterile surgical fields, thus it is imperative that they
strictly adhere to recommended infection control
practices.^{154 279-281} Breaks in aseptic technique,282
including use of common syringes,^{283 284} contaminated
infusion pumps,^{282 285-287} and the assembly of equipment in
advance of procedures,^{283 288} have been associated with SSI
outbreaks. Although a barrier (i.e., sterile drape) is placed between
the anesthesiologist's work area and the surgical field, SSIs have
occurred in which the source of the pathogen was the anesthesiologist
or a member of the anesthesia team (e.g., anesthesia
technician).^289-293 Continued efforts must be undertaken to
educate and reinforce the importance of good infection control
practices in preventing SSIs, not only to surgeons and operating room
nurses but to all members of the surgical team.^{282 294}
Hypothermia in surgical patients, defined as a core body
temperature below 36 deg.C, may result from general anesthesia,
exposure to cold, or intentional cooling such as, in cardiac procedures
to protect the myocardium or central nervous systems.^295-297
In one study of patients undergoing colorectal operations hypothermia
was associated with an increased risk of SSI.²⁹⁸ However,
since any alteration in normal homeostasis alters normal host
responses, more studies are needed to establish a relationship between
hypothermia and SSI risk.

Surgical Technique

Excellent surgical technique can reduce SSI risk. Maintaining
effective hemostasis while preserving adequate blood supply, gently
handling tissues, avoiding inadvertent entries into a viscus, removing
devitalized (e.g., necrotic or charred) tissues, using drains and
suture material appropriately, eradicating dead space, and appropriate
post-operative incision management are widely believed to reduce the
risk of SSI.^{18 19 31 32 299 300}
Any foreign body, including suture material or drains, may promote
inflammation at the surgical site ⁸⁷ and may increase the
probability of infection for some levels of tissue contamination. There
are two types of suture material: absorbable and non-absorbable. There
is extensive literature comparing different types of suture material
and their presumed relationships to SSI risk.^301-310 In
general, monofilament sutures appear to have the lowest infection-
promoting effects.^{3 18 31 87}
While appropriate decisions regarding drain placement are beyond
the scope of this document, general points should be briefly noted.
Drains placed through an operative incision increase SSI
risk.⁶⁷ Many researchers suggest placing drains through a
separate incision distant from the operating
incision.^{67 197 311} It appears that SSI risk decreases when
closed suction drains are used in comparison to open drains.
^{312 313} Closed suction drains are useful in evacuating
postoperative hematomas, seromas, and purulent material. Also, the
timing of drain removal is important; bacterial colonization of drains
tracts may increase as the duration of drainage
increases.³¹⁴

Postoperative Issues

Postoperative Incision Care

Whether the incision is closed primarily (i.e., the skin edges are
re-approximated at the end of the operation), left open to be closed
later, or left open to heal by secondary

[[Page 33175]]

intention determines the details of postoperative incision care.
When a surgical incision is closed primarily, as most are, the
surgeon has determined that it is relatively free of microbial
contamination (i.e., clean or clean-contaminated). The primarily closed
incision is covered with a sterile dressing for 24-48 hours until the
incision edges are sealed.^{315 316} Beyond 48 hours, it is
unclear whether an incision must be covered by a dressing or whether
showering or bathing is detrimental.
When a surgical incision is left open for a few days before it is
closed (delayed primary closure), a surgeon has determined that it is
likely to be contaminated, or that the patient's condition prevents
primary closure (e.g., edema at the site). At the end of the operation,
such an incision is packed with a sterile dressing (usually moist) and
is inspected daily during dressing changes until the decision is made
to close it. When a surgical incision is left open to heal by secondary
intention, it is also packed with sterile moist gauze and covered with
a sterile dressing. For wounds healing by secondary intention, there is
no consensus on the benefit of using sterile technique (i.e., using
sterile gloves and dressings) vs clean technique during dressing
changes. The American College of Surgeons, CDC, and others have
described changing dressings with sterile gloves and
equipment.^{31 317-320} However, a pilot study of 30 patients
examined the difference between sterile vs clean technique for dressing
changes of surgical incisions left open. No difference was found in SSI
rates and the clean technique was less expensive. However, larger
studies are needed to confirm these preliminary findings.³²¹

Discharge Planning: Care of the Surgical Site

Today, many patients are discharged soon after their operation,
with surgical incisions in the early process of healing.³²²
There are no set, specific protocols for home incision care, and much
of what is done at home by the patient, family, or home care agency has
to be individualized for each patient. The intent of discharge planning
is to maintain integrity of the healing incision, educate the patient
about the signs and symptoms of infection, and inform the patient about
whom to contact to report any problems. Written instructions and
repeated demonstrations may help reinforce consistency in following
verbal directions. It is the responsibility of the surgeon, nurse,
discharge planners, and home health agencies to educate the patient and
family in a uniform, concise, and coordinated fashion.

SSI Surveillance

Surveillance of SSI with feedback of appropriate data to surgeons
has been shown to be an important component of strategies to reduce SSI
risk.^{8, 323, 324} A successful surveillance program includes
epidemiologically sound infection definitions (Tables 1 and 2),
effective surveillance methods, and stratification of SSI rates
according to risk factors associated with SSI development.¹⁷

SSI Risk Stratification

Concepts
From the factors found to be associated with SSI, three categories
of variables have emerged as good predictors: (1) those that estimate
the intrinsic degree of microbial contamination of the surgical site,
(2) those that measure the duration of an operation, and (3) those that
serve as markers for host susceptibility.¹⁷ The probability
of developing an SSI depends upon the interaction of these variables in
a given patient.
A widely accepted scheme for classifying the degree of intrinsic
microbial contamination of a surgical site was developed by the 1964
National Academy of Sciences/National Research Council cooperative
research study and modified in 1982 by CDC for use in SSI surveillance
(Table 9).^{2, 87} In this scheme, a member of the surgical
team classifies the patient's wound at the completion of the operation.
Because of its ease and wide availability, the surgical wound
classification has been used to predict the risk of
SSI.^{8, 87, 325-330} Some researchers have suggested that
surgeons compare clean wound SSI rates with those of other
surgeons.^{8, 323} However, two CDC efforts--the Study on the
Efficacy of Nosocomial Infection Control (SENIC) Project and the NNIS
system--incorporated other predictor variables into SSI risk indices.
These showed that even within the category of clean wounds, the risk of
SSI varied from 1.1% to 15.8% and from 1.0% to 5.4%,
respectively.^328,331 In addition, sometimes the incision is
neither classified at the time of surgery nor assigned by a member of
the surgical team, calling into question the reliability of the
classification. Therefore, reporting SSI rates stratified by wound
class alone is not recommended.
Data on 10 variables collected in the SENIC Project were analyzed
by using logistic regression modeling to develop a simple additive SSI
risk index.³³¹ Four of these were found to be independently
associated with the risk of SSI: (1) an abdominal operation, (2) an
operation lasting >2 hours, (3) a surgical site with a wound
classification of either contaminated or dirty/infected, and (4) an
operation performed on a patient having 3 discharge
diagnoses. Each of these equally weighted factors contributes a point
when present, such that the risk index values range from 0 to 4. By
using these factors, the SENIC index was able to predict the risk of
SSI twice as well as the traditional wound classification scheme alone.
The NNIS risk index is operation specific and applied to
prospectively collected surveillance data. The index can range from 0
to 3 points and is defined by three independent and equally weighted
variables. A surgical patient scores one point when any of the
following are present: (1) American Society of Anesthesiologists (ASA)
class is 3 (Table 10), (2) wound classification is either
contaminated or dirty/infected, and (3) operation lasts >T hours, where
T is the approximate 75th percentile of the duration of the specific
operation being performed.³²⁸ The ASA class replaced
discharge diagnoses of the SENIC risk index as a proxy for the
patient's underlying severity of illness (host susceptibility) \332\
\333\ and is readily available in the chart during the patient's
hospital stay (Table 10). Unlike SENIC's constant 2 hour cut-point for
duration of operation, the operation-specific cut-points used in the
NNIS risk index have been shown to increase discriminatory
power.³²⁸
Issues
Adjustment for variables known to confound rate estimates is
critical if valid comparisons of SSI rates are to be made between
surgeons or hospitals.³³⁴ Risk stratification, as described
above, has proven useful for this purpose, but relies on the ability of
surveillance personnel to consistently and correctly find and record
the data. For the three variables used in the NNIS risk index, only one
study has focused on how accurately any of them are recorded. Cardo et
al. found that surgical team members' accuracy in assessing wound
classification for general and trauma surgery was 88% (95% CI: 82%-
94%).³³⁵ However, there are sufficient ambiguities in the
wound class definitions themselves to warrant concern about the
reproducibility of Cardo's results. The accuracy of recording the
duration of operation (i.e., time from skin incision to skin closure)
and the ASA class has not been studied. In an unpublished report from
the NNIS system, there was some evidence that

[[Page 33176]]

over-reporting of high ASA class existed in some hospitals (Emori TG,
personal communication). Further validation of how well the risk index
variables are recorded is needed.
Additionally, NNIS data show that the NNIS risk index does not
adequately discriminate the risk of SSI for all types of
operations.\336\ \337\ It seems likely that a combination of risk
factors specific to patients undergoing an operation will be more
predictive. A few studies have been performed to develop procedure-
specific risk indices ^338-342 and the NNIS system continues
research in this area.

SSI Surveillance Methods

SSI surveillance methods used in both the SENIC Project and the
NNIS system were designed for monitoring inpatients at acute-care
hospitals. Over the past decade, the shift from inpatient to outpatient
surgical care (also called ambulatory or day surgery) has been
dramatic. It has been estimated that 75% of all operations in the
United States will be performed in outpatient settings by the year
2000.\343\ While it may be appropriate to use common definitions of SSI
for inpatients and outpatients, ³⁴⁴ the types of operations
monitored, the risk factors assessed, and the case-finding methods used
may differ. New predictor variables may emerge from analyses of SSIs
among outpatient surgery patients, which may lead to different ways of
estimating SSI risk in this population.
Deciding upon which operations to monitor should be done jointly by
surgeons and infection control personnel. Rarely do hospitals have the
resources to monitor all surgical patients all the time, nor is that
level of surveillance intensity probably necessary for certain low-risk
procedures. Instead, hospitals should target surveillance efforts
towards high-risk procedures.³⁴⁵
Inpatient SSI Surveillance
Two methods, alone or together, have been used to identify
inpatients with SSIs: (1) direct observation of the surgical site by
the surgeon, trained nurse surveyor, or infection control personnel
^{8 90 323 326 346-350} and (2) indirect detection by infection
control personnel through review of laboratory reports, patient
records, and discussions with primary care
providers.^{7 77 323 326 329 346 348 351-357} The surgical
literature suggests that direct observation of surgical sites is the
most accurate method to detect SSIs, although sensitivity data are
lacking.^{8 323 326 347 348} Much of the SSI data reported in
the infection control literature have relied on indirect case-finding
methods,^{328 331 352 355 356 358-360} but some studies of
direct methods also have been conducted.^{90, 346} Some studies
use both methods of detection.^{77 325 346 354 357 361} A study
that focused solely on the sensitivity and specificity of SSIs detected
by indirect methods found a sensitivity of 83.8% (95% CI: 75.7%-91.9%)
and a specificity of 99.8% (95% CI: 99%-100%).³⁴⁶ Another
study showed that chart review triggered by a computer-generated report
of antibiotic orders for post-cesarean section patients had a
sensitivity of 89% for detecting endometritis.³⁶² It is
recommended that hospitals use direct, indirect, or a combination of
both methods for detecting SSI in postoperative inpatients.
Indirect SSI detection can readily be performed by infection
control personnel during surveillance rounds. The work includes
gathering demographic, infection, surgical, and laboratory data on
patients who have undergone operations of interest to the
investigator.²²⁴ These data can be obtained from patients'
medical records, including microbiology and histopathology laboratory
data and radiology reports, and records from the operating room.
Pharmacy records may be useful if data on prophylactic antimicrobial
use are to be collected. Additionally, hospital admissions, emergency
room, and clinic visit records are sources of data for those
postdischarge surgical patients who re-admitted or seek follow-up care.
The optimum frequency of case-finding by either method is unknown
and varies from daily to 3 times per week, continuing until
the patient is discharged from the hospital. Because duration of
hospitalization is now so short, postdischarge SSI surveillance has
become increasingly important to obtain accurate SSI rates (see
``Postdischarge SSI Surveillance'' section).
To calculate meaningful SSI rates, data must be collected on all
patients undergoing the operations of interest (i.e., the population at
risk). In the NNIS system, because one of its purposes is to develop
strategies for risk stratification, the following data are collected on
all surgical patients surveyed: operation date; NNIS operative
procedure category; ³⁶³ surgeon identifier; patient
identifier, age, and sex; duration of operation; wound class; general
anesthesia; ASA class; emergency; trauma; multiple procedures;
endoscopic approach; and discharge date.²²⁴ With the
exception of discharge date, these data can be obtained manually from
operating room logs or be electronically downloaded into surveillance
software, thereby substantially reducing manual transcription and data
entry errors.²²⁴ Depending on the needs for risk-stratified
SSI rates by infection control, surgery, and quality assurance, not all
data elements may be pertinent for every type of operation. At minimum,
however, variables found to be predictive of increased SSI risk should
be collected (see ``SSI Risk Stratification'' section).
Postdischarge SSI Surveillance
Between 12% and 84% of SSIs are detected after patients are
discharged from the hospital. ^{91 259 326 358 364-383} At
least two investigators have shown that most SSIs become evident within
21 days after operation.^{360 376} Since the length of
postoperative hospitalization continues to decrease, true estimates of
SSI risk will only be possible by performing a combination of inpatient
and postdischarge surveillance.
Postdischarge surveillance methods have been used with varying
degrees of success for different procedures and among hospitals and
include (1) direct examination of patients' wounds during follow-up
visits to either surgery clinics or physicians'
offices,^{323 326 329 360 365 369 370 376 381 384 385}
(2) review of medical records of surgery clinic
patients,^{329, 360, 368} (3) questionnaire administration to
patients by mail or telephone,^{364 366 367 370}
^{371 374 375 377 378 384 386 388} or
(4) questionnaire administration to surgeons by mail or
telephone.^{91 358 360}
^{366 368 372 373 375 377 379 380 384} One study found that
patients have difficulty assessing their own wounds for infection (52%
specificity, 26% positive predictive value),³⁸⁹ suggesting
that data obtained by patient questionnaire may inaccurately represent
actual SSI rates.
Recently, Sands et al. performed a computerized search of three
data bases--ambulatory encounter records for diagnostic, testing, and
treatment codes; pharmacy records for specific antimicrobial
prescriptions; and administrative records for rehospitalizations and
emergency room visits. The purpose of the search was to determine which
best identified SSIs.³⁷⁵ These researchers found that
pharmacy records indicating a patient had received antimicrobial agents
commonly used to treat soft tissue infections had the highest
sensitivity (50%) and positive predictive value (19%).
As integrated health information systems expand, tracking surgical
patients through the course of their care may become more feasible,
practical, and effective. Until then, there is no

[[Page 33177]]

consensus on which postdischarge surveillance methods are the most
sensitive, specific, and practical. Infection control and surgery
personnel must choose from a variety of methods to find those that work
for their unique mix of operations, personnel resources, and data
needs.
Outpatient SSI Surveillance
Both direct and indirect methods have been used to detect SSIs that
complicate outpatient operations. One study used home visits by
district health nurses combined with a questionnaire completed by the
surgeon at the patient's 2-week postoperative clinic visit to identify
SSIs in an 8-year study of operations for hernia and varicose
veins.³⁹⁰ While ascertainment was very high, essentially
100%, this method is impractical for widespread implementation. High
response rates have been obtained from questionnaires mailed to
surgeons (72%->90%).^{372 373 375 384 391 393} Response rates
from telephone questionnaires administered to patients were more
variable (38%,³⁸⁶ 81%,³⁸⁸ and 85%
³⁸⁴), and response rates from questionnaires mailed to
patients were quite low (15% ³⁸⁴ and 33% ³⁷⁵). At
this time, no single detection method can be recommended. Available
resources and data needs determine which method(s) should be used and
which operations should be monitored. It is recommended that the CDC
NNIS definitions of SSI (Tables 1 and 2) be used without modification
in the outpatient setting.

Guideline Evaluation Process

Users of the HICPAC guidelines determine their value. To help
assess that value, HICPAC is developing an evaluation tool to learn how
guidelines meet user expectations, and how and when these guidelines
are disseminated and implemented.

Part II--Recommendations for the Prevention of Surgical Site
Infections (SSIs)

Introduction

As in previous CDC guidelines, each recommendation is categorized
on the basis of existing scientific data, theoretical rationale,
applicability, and possible economic impact. However, the previous CDC
system for categorizing recommendations has been modified to include a
designation of those recommendations that are required by federal
regulations. The document does not recommend specific antiseptic agents
for patient preoperative skin preparations or for health-care worker
hand/forearm antisepsis. Hospitals should choose from the appropriate
products categorized by the Food and Drug Administration (FDA).\4\
Category IA. Strongly recommended for all hospitals and strongly
supported by well-designed experimental or epidemiological studies.
Category IB. Strongly recommended for all hospitals and viewed as
effective by experts in the field and a consensus of Hospital Infection
Control Practices Advisory Committee (HICPAC), based on strong
rationale and suggestive evidence, even though definitive scientific
studies may not have been done.
Category II. Suggested for implementation in many hospitals.
Recommendations may be supported by suggestive clinical or
epidemiological studies, a strong theoretical rationale, or definitive
studies applicable to some, but not all hospitals.
No recommendation; unresolved issue. Practices for which
insufficient evidence or no consensus regarding efficacy exists.

Recommendations

1. Preoperative preparation of the patient

a. Adequately control serum blood glucose level in all diabetic
patients before elective operation and maintain blood glucose level
<200 mg/dl during the operation and in the immediate postoperative
period (48 hours).^{77-79 100-102} Category IB
b. Always encourage tobacco cessation. At minimum, instruct
patients to abstain for at least 30 days before elective operation from
smoking cigarettes, cigars, pipes or any other form of tobacco
consumption (e.g., chewing/dipping).^{78 81 83-85} Category IB
c. No recommendation to taper or discontinue steroid use (when
medically permissible) before elective
operation.^{77 80 86 103-105} Unresolved issue
d. Consider delaying an elective operation in a severely
malnourished patient. A good predictor of nutritional status is serum
albumin.^{78 96-98} Category II
e. Attempt weight reduction in obese patients before elective
operation.^{78 79 89 90} Category II
f. Identify and treat all infections remote to the surgical site
before elective operation.^{31 74-76} Do not perform elective
operations in patients with remote site infections. Category IA
g. Keep preoperative hospital stay as short as
possible.^{18 75 93 104 106} Category IA
h. Prescribe preoperative showers/baths with an antiseptic agent
the night before and the morning of the operation.^{108 109}
Category IB
i. Do not remove hair preoperatively unless the hair at or around
the incision site will interfere with the
operation.^{8 93 113 114 120 121} Category IA
j. If hair is removed, it should be removed immediately before the
operation using electric clippers rather than razors or
depilatories.\115\ \117\ \119\ Category IA
k. Thoroughly wash and clean at and around the incision site to
remove gross contamination before performing antiseptic skin
preparation.\154\ Category IB
l. Use an acceptable antiseptic agent for skin preparation, such as
alcohol (usually 70%-92%), chlorhexidine (4%, 2%, or 0.5% in alcohol
base), or iodine/iodophors (usually 10% aqueous with 1% iodine or
formulation with 7.5%) (Table 5).\123\ \124\ Category IB
m. Apply preoperative antiseptic skin preparation in concentric
circles moving out toward the periphery. The prepped area must be large
enough to extend the incision or create new incisions or drain sites,
if necessary.\31\ \124\ \154\ Category IB

2. Preoperative Hand/Forearm Antisepsis

All members of the surgical team:
a. Keep nails short and do not wear artificial nails.\31\ \72\
\124\ \154\ \155\ Category IB
b. No recommendation on wearing nail polish. Unresolved Issue
c. Do not wear hand/arm jewelry. Category II
d. Perform a preoperative surgical scrub that includes hands and
forearms up to the elbows before the sterile field, sterile
instruments, or the patient's prepped skin is touched. Category IB
e. Clean underneath each fingernail prior to performing the
surgical scrub.\31\ \140\ \154\ Category IB
f. Perform the surgical scrub for a duration of 3-5 minutes \124\
\152\ \153\ with an appropriate antiseptic (see Table 5).\123\
\124\^-\140\ Category IB
g. After performing the surgical scrub, keep hands up and away from
the body (elbows in flexed position) so that water runs from the tips
of the fingers toward the elbows. Dry hands with a sterile towel and
don a sterile gown and gloves.\154\ Category IB

3. Antimicrobial Prophylaxis

a. Select a prophylactic antimicrobial agent based on its efficacy
against the most common pathogens causing SSI for a specific operation
(Table 6). Category IA
b. Administer the antimicrobial prophylactic agent by the
intravenous route except for colorectal operations.\202\ In colorectal
operations the antimicrobial agent is administered orally, or a
combination of oral and intravenous route is used. Category IA

[[Page 33178]]

c. Administer the antimicrobial agent before the operation starts
to assure adequate microbiocidal tissue levels before the skin incision
is made, ideally antimicrobial prophylaxis should be administered
within 30 minutes before, but not longer than 2 hours before, the
initial incision.\69\ \71\ \202\ \203\ \214\ Category IA
d. For cesarean section, administer prophylaxis immediately after
the umbilical cord is clamped.\69\ \70\ Category IA
e. Administer prophylactic antimicrobial agent as close as possible
to the time of induction of anesthesia. Category II
f. Do not extend prophylaxis
postoperatively.^{47 71 199 -201} Category IB
g. Consider additional intraoperative doses under the following
circumstances: (1) operations whose duration exceeds the estimated
serum half-life of the agent, (2) operations with major intraoperative
blood loss, and (3) operations on morbidly obese
patients.^{47 69 71 201 203 216 -218} Category IB
h. Do not routinely use vancomycin for prophylaxis.\204\ \205\
Category IB

4. Intraoperative Issues

4-1. Operating Room Environment
A. Ventilation
a. Maintain positive-pressure ventilation in the operating room
with respect to the corridors and adjacent areas.\226\ Category IB
b. Maintain a minimum of 15 air changes per hour, of which at least
3 should be fresh air.\226\ Category IB
c. Filter all air, recirculated and fresh, through the appropriate
filters per the American Institute of Architects recommendations.\226\
Category IB
d. Introduce all air at the ceiling and exhaust near the
floor.\227\ \228\ Category IB
e. No recommendation for the use of laminar flow ventilation or
ultraviolet lights in the operating room to prevent
SSI.^{87 225 232 -237} Unresolved issue
f. Keep operating room doors closed except as needed for passage of
equipment, personnel, and the patient.\219\ Category IB
g. Limit the number of personnel entering the operating room to
necessary personnel.\219\ Category IB
B. Cleaning and Disinfection of Environmental Surfaces
a. No recommendation on disinfecting operating rooms between
operations in the absence of visible soiling of surfaces or equipment.
Unresolved issue
b. When visible soiling or contamination, with blood or other body
fluids, of surfaces or equipment occurs during an operation, use an
EPA-approved hospital disinfectant to clean the affected areas before
the next operation.^{31 154 227 -229 238 -240} Category IB*
c. Wet vacuum the operating room floor after the last operation of
the day or night with an EPA-approved hospital disinfectant.\154\
Category IB
d. Do not perform special cleaning or disinfection of operating
rooms after contaminated or dirty operations.\227\ \228\ Category IA
e. Do not use tacky mats at the entrance to the operating room
suite for infection control; this is not proven to decrease SSI
risk.^{1 18 219 228} Category 1A
C. Microbiologic Sampling
Do not perform routine environmental sampling of the operating
room. Perform microbiologic sampling of operating room environmental
surfaces or air only as part of an epidemiologic investigation.
Category IB
D. Sterilization of Surgical Instruments
a. Sterilize all surgical instruments according to published
guidelines.\154\ \226\ \239\ \245\ Category IB
b. Perform flash sterilization only in emergency
situations.^{239 244 -246} Category IB
c. Do not use flash sterilization for routine reprocessing of
surgical instruments. Category IB
4-2. Surgical Attire and Drapes
a. No recommendations on how or where to launder scrub suits, on
restricting use of scrub suits to the operating suite or for covering
scrub suits when out of the operating suite.\154\ \277\ Unresolved
issue
b. Change scrub suits when visibly soiled, contaminated and/or
penetrated by blood or other potentially infectious materials.\154\
\240\ Category IB *
c. Wear a surgical mask that fully covers the mouth and nose when
entering the operating room if sterile instruments are exposed, or if
an operation is about to begin or already under way. Wear the mask
throughout the entire operation.\154\ \240\ Category IB *
d. Wear a cap or hood to fully cover hair on the head and face when
entering the operating room suite.\154\ \240\ \248\ \261\ Category IB *
e. Do not wear shoe covers for the prevention of SSI.\262\ \263\
Category IA
f. Wear shoe covers when gross contamination can reasonable be
anticipated.\240\ Category II *
g. The surgical team must wear sterile gloves, which are put on
after donning a sterile gown.\240\ \264\^-\266\ Category IB *
h. Use materials for surgical gowns and drapes that are effective
barriers when wet.\1\ \154\ \169\ \277\ Category IB
4-3. Practice of Anesthesiology
Anesthesia team members must adhere to recommended infection
control practices during operations.\154\ \279\^-\281\
Category IA
4-4. Surgical Technique
a. Handle tissue gently, maintain effective hemostasis, minimize
devitalized tissue and foreign bodies (i.e., sutures, charred tissues,
necrotic debris), and eradicate dead space at the surgical site.\18\
\19\ \31\ \32\ Category IB
b. Use delayed primary closure or leave incision open to close by
secondary intention, if the surgical site is heavily contaminated
(e.g., Class III and Class IV). Category IB
c. If drainage is deemed necessary, use a closed suction drain.
Place the drain through a separate incision, rather than the main
surgical incision. Remove the drain as soon as possible.\312\ \313\
Category IB

5. Postoperative Surgical Incision Care

a. Protect an incision closed primarily with a sterile dressing for
24-48 hours postoperatively. Also ensure that the dressing remains dry
and that it is not removed bathing.\315\ \316\ Category IA
b. No recommendation on whether or not to cover an incision closed
primarily beyond 48 hours, nor on the appropriate time to shower/bathe
with an uncovered incision. Unresolved Issue
c. Wash hands with an antiseptic agent before and after dressing
changes, or any contact with the surgical site. Category IA
d. For incisions left open postoperatively, no recommendation for
dressing changes using a sterile technique vs. clean technique.
Unresolved Issue
e. Educate the patient and family using a coordinated team approach
on how to perform proper incision care, identify signs and symptoms of
infection, and where to report any signs and symptoms of infection.
Category II

6. Surveillance

a. Use CDC definitions of SSI \16\ without modification for
identifying SSI among surgical inpatients and outpatients. Category IB
---------------------------------------------------------------------------

*Federal regulation--Occupational Safety and Health
Administration
---------------------------------------------------------------------------

b. For inpatient case-finding, use direct prospective observation,
indirect prospective detection, or a combination of both direct and
indirect methods for the duration of the patient's hospitalization, and
include a method of postdischarge surveillance that accommodates
available resources and data needs. Category IB

[[Page 33179]]

c. For outpatient case-finding, use a method that accommodates
available resources and data needs. Category IB
d. For each patient undergoing an operation chosen for
surveillance, record those variables shown to be associated with
increased SSI risk (e.g., surgical wound class, ASA class, and duration
of operation). Category IB
e. Upon completion of the operation, a surgical team member assigns
the surgical wound classification. Category IB
f. Periodically calculate operation-specific SSI rates stratified
by variables shown to be predictive of SSI risk. Category IB
g. Report appropriately stratified, operation-specific SSI rates to
surgical team members. The optimum frequency and format for such rate
computations will be determined by stratified case-load sizes and the
objectives of local, continuous, quality improvement initiatives.
Category IB
h. No recommendation to make available to the infection control
committee coded surgeon-specific data. Unresolved issue

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405. Aznar R, Mateu M, Miro JM, Gatell JM, Gimferrer JM, Aznar
E, et al. Antibiotic prophylaxis in non-cardiac thoracic surgery:
cafazolin versus placebo. Eur J Cardiothorac Surg 1991; 5:515-518.
406. Cant PJ, Smyth S, Smart DO. Antibiotic prophylaxis is
indicated for chest stab wounds requiring closed tube thoracostomy.
Br J Surg 1993; 80:464-466.
407. Pitt HA, Postier RG, MacGowan WAL, Frank LW, Surmak AJ,
Sitzman JV, et al. Prophylactic antibiotics in vascular surgery:
topical, systemic, or both? Ann Surg 1980; 192:356-364.
408. Kaiser AB, Clayson KR, Mulherin JL, Jr., Roach AC, Allen
TR, Edwards WH, et al. Antibiotic prophylaxis in vascular surgery.
Ann Surg 1978; 188:283-289.
409. Bauer T, Vennits B, Holm B, Hahn-Pedersen J, Lysen D,
Galatius H, et al. Antibiotic prophylaxis in acute nonperforated
appendicitis. Ann Surg 1989; 209:307-311.
410. Krukowski ZH, Irwin ST, Denholm S, Matheson NA. Preventing
wound infection after appendicectomy: a review. Br J Surg 1988;
75:1023-1033.
411. Skipper D, Corder AP, Karran SJ. A randomized prospective
study to compare ceftizoxime with cephradine as single dose
prophylaxis in elective cholecystectomy. J Hosp Infect 1991; 17:303-
306.
412. Kaufman Z, Engelberg M, Eliashiv A, Reiss R. Systemic
prophylactic antibiotics in elective biliary surgery. Arch Surg
1984; 119:1002-1004.
413. Grant MD, Jones RC, Wilson SE, Bombeck CT, Flint LM,
Jonasson O, et al. Single dose cephalosporin prophylaxis in high-
risk patients undergoing surgical treatment of the biliary tract.
Surgery, Gynecology & Obstetrics 1992; 174:347-354.
414. Lewis RT, Goodall RG, Marien B, Park M, Lloyd-Smith W,
Wiegand FM. Biliary bacteria, antibiotic use, and wound infection in
surgery of the gallbladder and common bile duct. Arch Surg 1987;
122:44-47.
415. Saltzstein EC, Mercer LC, Peacock JB, Dougherty SH.
Oupatient open cholecystectomy. Surgery, Gynecology & Obstetrics
1992; 174:173-175.
416. Meijer WS, Schmitz PIM, Jeekel J. Meta-analysis of
randomized controlled clinical trails of antibiotic prophylaxis in
biliary tract surgery. Br J Surg 1990; 77:283-290.
417. Kaiser AB, Herrington JL, Jr., Jacobs JK, Mulherin JL, Jr.,
Roach AC, Sawyers JL. Cefoxitin versus erythromycin, neomycin, and
cefazolin in colorectal operations. Ann Surg 1983; 198:525-530.
418. Schoetz DJ, Jr., Roberts PL, Murray JJ, Coller JA,
Veidenheimer MC. Addition of parenteral cefoxitin to regimen of oral
antibiotics for elective colorectal operations. Ann Surg 1990;
212:209-212.
419. Edmondson HT, Rissing JP. Prophylactic antibiotics in colon
surgery. Arch Surg 1983; 118:227-231.
420. Rotman N, Hay JM, Lacaine F, Fagniez PL, The Association de
Recherche en Chirurgie Cooperative Group. Prophylactic
antibiotherapy in abdominal surgery: first- vs. third-generation
cephalosporins. Arch Surg 1989; 124:323-327.
421. Lewis RT, Allan CM, Goodall RG, Marien B, Park M, Lloyd-
Smith W, et al. Cefamandole in gastroduodenal surgery: a controlled,
prospective, randomized, double-blind study. Can J Surg 1982;
25:561-563.
422. McArdle CS, Morran CG, Anderson JR, Pettit L, Gemmell CG,
Sleigh JD, et al. Oral ciprofloxacin as prophylaxis in
gastroduodenal surgery. J Hosp Infect 1995; 30:211-216.
423. Grandis JR, Vickers RM, Rihs JD, Yu VL, Johnson JT.
Efficacy of topical amoxicillin plus clavulanate/ticarcillin plus
clavulanate and clindamycin in contaminated head and neck surgery:
effect of antibiotic spectra and duration of therapy. J Infect Dis
1994; 170:729-732.
424. Johnson JT, Yu VL, Myers EN, Wagner RL. An assessment of
the need for gram-negative bacterial coverage in antibiotic
prophylaxis for oncological head and neck surgery. J Infect Dis
1987; 155:331-333.
425. Elledege ES, Whiddon RG, Jr., Fraker JT, Stambaugh KI. The
effects of topical oral clindamycin antibiotic rinses on the
bacterial content of salvia on healthy human subjects. Otolaryngol
Head Neck Surg 1991; 105:836-839.
426. Johnson JT, Yu VL, Myers EN, Wagner RL, Sigler BA.
Cefazolin vs. moxalactam? Arch Otolaryngol Head Neck Surg 1986;
112:151-153.
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infections. Rev Infect Dis 1983; 5:S90

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Table 1.--Criteria for Defining Surgical Site Infection (SSI).\16\
------------------------------------------------------------------------

-------------------------------------------------------------------------
SUPERFICIAL INCISIONAL SSI
------------------------------------------------------------------------
Infection occurs within 30 days after the operation and infection
involves only skin or subcutaneous tissue of the incision and at least
one of the following:
1. Purulent drainage, with or without laboratory confirmation, from
the superficial incision.
2. Organisms isolated from an aseptically obtained culture of fluid
or tissue from the superficial incision.
3. At least one of the following signs or symptoms of infection:
pain or tenderness, localized swelling, redness, or heat and
superficial incision is deliberately opened by surgeon, unless
incision is culture-negative.
4. Diagnosis of superficial incisional SSI by the surgeon or
attending physician.
Do not report the following conditions as SSI:
1. Stitch abscess (minimal inflammation and discharge confined to
the points of suture penetration).
2. Infection of an episiotomy or newborn circumcision site.^{3
3. Infected burn wound.^{3
4. Incisional SSI that extends into the fascial and muscle layers
(see deep incisional SSI).
------------------------------------------------------------------------
DEEP INCISIONAL SSI
------------------------------------------------------------------------
Infection occurs within 30 days after the operation if no implant ^{4 is
left in place or within 1 year if implant is in place and the infection
appears to be related to the operation and
Infection involves deep soft tissues (e.g., fascial and muscle layers)
of the incision and at least one of the following:
1. Purulent drainage from the deep incision but not from the organ/
space component of the surgical site.
2. A deep incision spontaneously dehisces or is deliberately opened
by a surgeon when the patient has at least one of the following
signs or symptoms: fever (>38 deg.C), localized pain, or
tenderness, unless site is culture negative.
3. An abscess or other evidence of infection involving the deep
incision is found on direct examination, during reoperation, or by
histopathologic or radiologic examination.
4. Diagnosis of a deep incisional SSI by a surgeon or attending
physician.

Notes:

1. Report infection that involves both superficial and deep incision
sites as deep incisional SSI.
2. Report an organ/space SSI that drains through the incision as a
deep incisional SSI.
------------------------------------------------------------------------
ORGAN/SPACE SSI
------------------------------------------------------------------------
Infection occurs within 30 days after the operation if no implant is
left in place or within 1 year if implant is in place and the infection
appears to be related to the operation and
Infection involves any part of the anatomy (e.g., organs or spaces),
other than the incision, that was opened or manipulated during the
operative procedure and at least one of the following:
1. Purulent drainage from a drain that is placed through a stab
wound ^{5 into the organ/space.
2. Organisms isolated from an aseptically obtained culture of fluid
or tissue in the organ/space.
3. An abscess or other evidence of infection involving the organ/
space that is found on direct examination, during reoperation, or
by histopathologic or radiologic examination.
4. Diagnosis of an organ/space SSI by a surgeon or attending
physician.
------------------------------------------------------------------------
^{3 Specific criteria are used for infected episiotomy and circumcision
sites and burn wounds.
^{4 NNIS definition--A nonhuman-derived implantable foreign body (e.g.,
prosthetic heart valve, nonhuman vascular graft, mechanical heart, or
hip prosthesis) that is permanently placed in a patient during
surgery.
^{5 If the area around a stab wound becomes infected, it is not an SSI^{1.
It is considered a skin or soft tissue infection, depending on its
depth.

Table 2.--Specific Sites of Organ/Space Surgical Site Infection \16\
------------------------------------------------------------------------

-------------------------------------------------------------------------
Arterial or venous infection
Breast abscess or mastitis
Disc space
Ear, mastoid
Endocarditis
Endometritis
Eye, other than conjunctivitis
Gastrointestinal tract
Intraabdominal, not specified elsewhere
Intracranial, brain abscess or dura
Joint or bursa
Mediastinitis
Meningitis or ventriculitis
Myocarditis or pericarditis
Oral cavity (mouth, tongue, or gums)
Osteomyelitis
Other infections of the lower respiratory tract (e.g., abscess or
empyema)
Other male or female reproductive tract
Sinusitis
Spinal abscess without meningitis
Upper respiratory tract, pharyngitis
Vaginal cuff
------------------------------------------------------------------------

Table 3.--Distribution of Pathogens Isolated * From Surgical Site
Infections, National Nosocomial Infections Surveillance System, 1986-
1996.\6\ \18\ \19\
------------------------------------------------------------------------
Percent of isolates
----------------------------------------
1986-1989 1990-1996
------------------------------------------------------------------------
Pathogen....................... (N=16,727) (N=17,671)
Staphylococcus aureus.......... 17 20
Coagulase-negative 12 14
staphylococci.
Escherichia coli............... 10 8
Enterococcus spp............... 8 12

[[Page 33190]]

Pseudomonas aeruginosa......... 8 8
Enterobacter spp............... 8 7
Proteus mirabilis.............. 4 3
Klebsiella pneumoniae.......... 3 3
Other Streptococcus spp........ 3 3
Candida albicans............... 2 3
Group D streptococci........... ................... 2
Other gram-positive aerobes.... ................... 2
Bacteroides fragilis........... ................... 2
------------------------------------------------------------------------
* Pathogens representing less than 2% of isolates are excluded.

Table 4.--Factors That Influence Surgical Site Infection Risk
------------------------------------------------------------------------

-------------------------------------------------------------------------
INTRINSIC--Patient-Related Risk Factors
Age
Nutritional status
Diabetes
Smoking
Obesity
Remote infections
Endogenous mucosal microorganisms
Altered immune response
Preoperative stay--severity of illness
EXTRINSIC--Operation-Related Risk Factors
Duration of surgical scrub
Skin antisepsis
Preoperative shaving
Preoperative skin prep
Surgical attire
Sterile draping
Duration of operation
Antimicrobial prophylaxis
Ventilation
Sterilization of instruments
Wound class
Foreign material
Surgical drains
Exogenous microorganisms
Surgical technique
Poor hemostasis
Failure to obliterate dead space
Tissue trauma
------------------------------------------------------------------------
This table has been adopted from references.^{17 ^{and ^{29

Table 5.--Mechanism and Spectrum of Activity for Commonly Used Antiseptics for Preoperative Skin Preparation and Surgical Scrubs.\123\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Gram-positive Gram-negative Mycobacterium Residual
Agent Mechanism of action bacteria * bacteria * tuberculosis * Fungi * Virus * Rapidity of action activity * Toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Alcohol......................... Denature proteins.. E E G G G Most rapid............. None........... Drying, volatile.
Chlorhexidine................... Disrupt cell wall.. E G P F G Intermediate........... E.............. Ototoxicity,
Keratitis.
Iodine/Iodophors................ Oxidation/ E G G G G Intermediate........... Minimal........ Absorption from
substitution by skin with
free iodine. possible
toxicity, skin
irritation.
** PCMX......................... Disrupt cell wall.. G F F F F Intermediate........... Good........... More data needed.
Triclosan....................... Disrupt cell wall.. G G G P U Intermediate........... E.............. More data needed.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
** Para-chloro-meta-xylenol
Good except for Pseudomonas
* E--excellent. G--good. F--fair. P--poor. U--unknown.

Table 6.--Operations, Likely Surgical Site Infection Pathogens, and References Regarding Usage of Antimicrobial
Prophylaxis
----------------------------------------------------------------------------------------------------------------
Operations Likely pathogens
----------------------------------------------------------------------------------------------------------------
Clean--Class I Endogenous and Exogenous
----------------------------------------------------------------------------------------------------------------
Placement of all grafts, prostheses, or implants \47\ S. aureus, S. epidermidis.
\69\ \197\ \202\ \203\.
Cardiac ^{190 ^{192-194 ^{205................................ S. aureus, S. epidermidis.
Neurosurgery ^{170-174 ^{394 ^{395........................... S. aureus, S. epidermidis.
If approach through nasopharynx or transphenoid sinus
are Class II.
Ophthalmology \396\ \397\.............................. S. aureus; S. epidermidis; streptococci; enteric, gram-
--Limited data. negative bacilli.
--However, commonly used in procedures such as
anterior segment resection, vitrectomy, and scleral
buckles.

[[Page 33191]]

Orthopedic ^{57 ^{69 ^{175-180 ^{398-404....................... S. aureus, S. epidermidis.
--Total joint replacement.
--Closed fractures/use of nails, bone plates, other
internal fixation devices.
--Functional repair without implant/device.
--Trauma
Pulmonary (noncardiac thoracic) \188\ \191\ \405\ \406\ S. aureus; S. epidermidis; Streptococcus pneumoniae;
--Thoracic (lobectomy, pneumonectomy, wedge enteric, gram-negative bacilli.
resection, other non-cardiac mediastinal procedures)
--Closed tube thoracostomy
Vascular \69\ \189\ \197\ \205\ \407\ \408\............ S. aureus, S. epidermidis.
----------------------------------------------------------------------------------------------------------------
Clean--Contaminated--Class II *
----------------------------------------------------------------------------------------------------------------
Appendectomy ^{185 ^{409 ^{410............................... Enteric, gram-negative bacilli, anaerobes.
Biliary (cholecystectomy) ^{186 ^{187 ^{411-416.............. Enteric, gram-negative bacilli, anaerobes.
--For high risk (e.g., age >65, jaundice, acute
cholecystitis, choledocholithiasis, or prior biliary
surgery) and low-risk patients.
Colorectal............................................. Enteric, gram-negative bacilli, anaerobes.
--Oral.^{71 ^{181 ^{182 ^{184 ^{202 ^{206-213
--Oral and IV.^{184 ^{211 ^{417-419
Gastroduodenal ^{183 ^{184 ^{420-422......................... Enteric, gram-negative bacilli, enterococci.
Head and neck (major procedures with incision through S. aureus, streptococci, oral anaerobes (e.g.,
oral or pharyngeal mucosa ^{423-426. peptostreptococci).
Obstetric and gynecologic ^{159-168 ^{203 ^{364.............. Enteric, gram-negative bacilli; enterococci; group B
--Cesarean section. streptococci; anaerobes.
Low risk and high risk (high risk = prolonged rupture
of membranes, no prenatal care, multiple vaginal
examines, emergency cesarean, frequent invasive
monitoring).
--Hysterectomy.
Vaginal and abdominal
Urology--prostate ^{68 ^{69 ^{198 ^{203........................ Escherichia coli, Klebsiella spp. Pseudomonas.
May not be beneficial if urine is sterile.
Exploratory laparotomy................................. Aerobic coliforms Bacteroides fragilis and other
Penetrating abdominal trauma.^{193 ^{338 ^{339 ^{427 ^{428 anaerobes.
----------------------------------------------------------------------------------------------------------------
* Staphylococci will cause a certain amount of infections in all procedures.

Table 7.--Department of Health and Human Services' Parameters for
Operating Room Ventilation, American Institute of Architects, 1996.\226\
------------------------------------------------------------------------

------------------------------------------------------------------------
Normal temperature..................... 68-73 deg.F depending on normal
ambient temperatures.
Relative humidity...................... 30%-60%.
Air movement........................... Out ``clean to less clean''
areas.
Air Changes............................ Minimum 15 total air changes
per hour.
Minimum 3 air changes of
outdoor air per hour.
------------------------------------------------------------------------

Table 8.--Association for the Advancement of Medical Instruments Flash
Sterilization Cycle Parameters.\245\
------------------------------------------------------------------------

------------------------------------------------------------------------
Gravity-displacement cycles Minimum exposure time and
temperature
Porous and nonporous items............. Nonporous items--3 min at 132
deg.C (270 deg.F)
Nonporous and porous items--10
min at 132 deg.C (270 deg.F)

Prevacuum cycles Minimum exposure time and
temperature
Porous and nonporous items............. Nonporous items (270 deg.F)--3
min at 132 deg.C
Nonporous and porous items (270
deg.F)--4 min at 132 deg.C
------------------------------------------------------------------------

[[Page 33192]]

Table 9.--Surgical Wound Classification.^{1 ^{2
------------------------------------------------------------------------

-------------------------------------------------------------------------
Class I/Clean: An uninfected operative wound in which no inflammation is
encountered and the respiratory, alimentary, genital, or uninfected
urinary tract is not entered. In addition, clean wounds are primarily
closed and, if necessary, drained with closed drainage. Operative
incisional wounds that follow nonpenetrating (blunt) trauma should be
included in this category if they meet the criteria.
Class II/Clean-Contaminated: An operative wound 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.
Class III/Contaminated: Open, fresh, accidental wounds. In addition,
operations with major breaks in sterile technique (e.g., open cardiac
massage) or gross spillage from the gastrointestinal tract, and
incisions in which acute, nonpurulent inflammation is encountered are
included in this category.
Class IV/Dirty-Infected: Old traumatic wounds with retained devitalized
tissue and those that involve existing clinical infection or perforated
viscera. This definition suggests that the organisms causing
postoperative infection were present in the operative field before the
operation.
------------------------------------------------------------------------

Table 10.--American Society of Anesthesiologists' (ASA) Physical Status
Classification
------------------------------------------------------------------------
Code Patient's preoperative physical status
------------------------------------------------------------------------
1.............................. Normally healthy patient.
2.............................. Patient with mild systemic disease.
3.............................. Patient with severe systemic disease
that is not incapacitating.
4.............................. Patient with an incapacitating systemic
disease that is a constant threat to
life.
5.............................. Moribund patient who is not expected to
survive for 24 hours with or without
operation.
------------------------------------------------------------------------

[FR Doc. 98-15551 Filed 6-16-98; 8:45 am]
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