[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

[[Page 33170]]

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.

[[Page 33171]]

    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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    402. Tripple SB. Antibiotic-impregnated cement in total joint 
arthroplasty. J Bone Joint Surg 1986; 68A:1297-1302.
    403. Nungu KS, Olerud C, Rehnberg L, Larsson S, Nordell P, 
Allvin I, et al. Prophylaxis with oral cefadroxil versus intravenous 
cefuroxime in trochanteric

[[Page 33187]]

fracture surgery: A clinical multicentre study. Arch Orthop Trauma 
Surg 1995; 114:303-307.
    404. Norden CW. Antibiotic prophylaxis in orthopedic surgery. 
Rev Infect Dis 1991; 13:S842-S846.
    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.
    427. Jones RC, Thal ER, Johnson NA, Gollohar LN. Evaluation of 
antibiotic therapy following penetrating abdominal trauma. Ann Surg 
1985; 201:576-585.
    428. Nichols RL. Empiric antibiotic therapy for intraabdominal 
infections. Rev Infect Dis 1983; 5:S90

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[GRAPHIC] [TIFF OMITTED] TN17JN98.001



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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 SSI1.  
  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]
BILLING CODE 4163-18-P