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Guideline for Prevention of Surgical Site Infection, 1999

2. Operative characteristics: Preoperative issues

a. Preoperative antiseptic showering

A preoperative antiseptic shower or bath decreases skin microbial colony counts. In a study of >700 patients who received two preoperative antiseptic showers, chlorhexidine reduced bacterial colony counts ninefold (2.8×102 to 0.3), while povidone-iodine or triclocarbanmedicated soap reduced colony counts by 1.3- and 1.9-fold, respectively.[155] Other studies corroborate these findings. [156,157] Chlorhexidine gluconate-containing products require several applications to attain maximum antimicrobial benefit, so repeated antiseptic showers are usually indicated. [158] Even though preoperative showers reduce the skin’s microbial colony counts, they have not definitively been shown to reduce SSI rates.[159-165]


b. Preoperative hair removal

Preoperative shaving of the surgical site the night before an operation is associated with a significantly higher SSI risk than either the use of depilatory agents or no hair removal.[16,100,166-169] 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 who had no hair removed.[166] The increased SSI risk associated with shaving has been attributed to microscopic cuts in the skin that later serve as foci for bacterial multiplication. Shaving immediately before the operation compared to shaving within 24 hours preoperatively was associated with decreased SSI rates (3.1% vs 7.1%); if shaving was performed >24 hours prior to operation, the SSI rate exceeded 20%.[166] Clipping hair immediately before an operation also has been 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%).[170-173] Although the use of depilatories has been associated with a lower SSI risk than shaving or clipping,[166,167] depilatories sometimes produce hypersensitivity reactions.[166] Other studies showed that preoperative hair removal by any means was associated with increased SSI rates and suggested that no hair be removed.[100,174,175]


c. Patient skin preparation in the operating room

Several antiseptic agents are available for preoperative preparation of skin at the incision site (Table 6). The iodophors (e.g., povidone-iodine), alcohol-containing products, and chlorhexidine gluconate are the most commonly used agents. No studies have adequately assessed the comparative effects of these preoperative skin antiseptics on SSI risk in well-controlled, operation-specific studies.

Alcohol is defined by the FDA as having one of the following active ingredients: ethyl alcohol, 60% to 95% by volume in an aqueous solution, or isopropyl alcohol, 50% to 91.3% by volume in an aqueous solution.[12] Alcohol is readily available, inexpensive, and remains the most effective and rapid-acting skin antiseptic.[176] Aqueous 70% to 92% alcohol solutions have germicidal activity against bacteria, fungi, and viruses, but spores can be resistant.[176,177] One potential disadvantage of the use of alcohol in the operating room is its flammability.[176-178]

Both chlorhexidine gluconate and iodophors have broad spectra of antimicrobial activity.[177,179-181] In some comparisons of the two antiseptics when used as preoperative hand scrubs, chlorhexidine gluconate achieved greater reductions in skin microflora than did povidone-iodine and also had greater residual activity after a single application. [182-184] Further, chlorhexidine gluconate is not inactivated by blood or serum proteins.[176,179,185,186] Iodophors may be inactivated by blood or serum proteins, but exert a bacteriostatic effect as long as they are present on the skin.[178,179]

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).187 The patient’s skin is prepared by applying an antiseptic in concentric circles, beginning in the area of the proposed incision. The prepared area should be large enough to extend the incision or create new incisions or drain sites, if necessary.[1,177,187] 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).

There are reports of modifications to the procedure for preoperative skin preparation which include: (1) removing or wiping off the skin preparation antiseptic agent after application, (2) using an antiseptic-impregnated adhesive drape, (3) merely painting the skin with an antiseptic in lieu of the skin preparation procedure described above, or (4) using a "clean" versus a "sterile" surgical skin preparation kit.[188-191] However, none of these modifications has been shown to represent an advantage.


d. Preoperative hand/forearm antisepsis

Members of the surgical team who have direct contact with the sterile operating field or sterile instruments or supplies used in the field 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 used for the scrub should have a broad spectrum of activity, be fastacting, and have a persistent effect.[1,192,193] Antiseptic agents commercially available in the United States for this purpose contain alcohol, chlorhexidine, iodine/iodophors, parachloro- meta-xylenol, or triclosan (Table 6).[176,177,179,194,195] Alcohol is considered the gold standard for surgical hand preparation in several European countries.[196-199] Alcohol containing products are 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.[177] 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.[200,201] 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 use. Unfortunately, most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No clinical trials have evaluated the impact of scrub agent choice on SSI risk.[195,202-206]

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. Recent studies suggest that scrubbing for at least 2 minutes is as effective as the traditional 10-minute scrub in reducing hand bacterial colony counts,[207-211] but the optimum duration of scrubbing is not known. The first scrub of the day should include a thorough cleaning underneath fingernails (usually with a brush).[180,194,212] It is not clear that such cleaning is a necessary part of subsequent scrubs during the day. After performing the surgical scrub, hands should be kept up and away from the body (elbows in flexed position) so that water runs from the tips of the fingers toward the elbows. Sterile towels should be used for drying the hands and forearms before the donning of a sterile gown and gloves.[212]

A surgical team member who wears artificial nails may have increased bacterial and fungal colonization of the hands despite performing an adequate hand scrub.[212,213] Hand carriage of gram-negative organisms has been shown to be greater among wearers of artificial nails than among non-wearers.[213] An outbreak of Serratia marcescens SSIs in cardiovascular surgery patients was found to be associated with a surgical nurse who wore artificial nails.[214] While the relationship between nail length and SSI risk is unknown, long nails—artificial or natural— may be associated with tears in surgical gloves.[177,180,212] The relationship between the wearing of nail polish or jewelry by surgical team members and SSI risk has not been adequately studied.[194,212,215-217]


e. Management of infected or colonized surgical personnel

Surgical personnel who have active infections or are colonized with certain microorganisms have been linked to outbreaks or clusters of SSIs.[33,34,76,218-237] Thus, it is important that healthcare organizations implement policies to prevent transmission of microorganisms from personnel to patients. These policies should address management of jobrelated illnesses, provision of postexposure prophylaxis after job-related exposures and, when necessary, exclusion of ill personnel from work or patient contact. While work exclusion policies should be enforceable and include a statement of authority to exclude ill personnel, they should also be designed to encourage personnel to report their illnesses and exposures and not penalize personnel with loss of wages, benefits, or job status.[238]


f. Antimicrobial prophylaxis

Surgical antimicrobial prophylaxis (AMP) refers to a very brief course of an antimicrobial agent initiated just before an operation begins.[239-265] AMP is not an attempt to sterilize tissues, but a critically timed adjunct used to reduce the microbial burden of intraoperative contamination to a level that cannot overwhelm host defenses. AMP does not pertain to prevention of SSI caused by postoperative contamination.[265] Intravenous infusion is the mode of AMP delivery used most often in modern surgical practice. [20,26,242,266-281] Essentially all confirmed AMP indications pertain to elective operations in which skin incisions are closed in the operating room.

Four principles must be followed to maximize the benefits of AMP:

  • Use an AMP agent for all operations or classes of operations in which its use has been shown to reduce SSI rates based on evidence from clinical trials or for those operations after which incisional or organ/space SSI would represent a catastrophe.[266,268,269,282-284]
  • Use an AMP agent that is safe, inexpensive, and bactericidal with an in vitro spectrum that covers the most probable intraoperative contaminants for the operation.
  • Time the infusion of the initial dose of antimicrobial agent so that a bactericidal concentration of the drug is established in serum and tissues by the time the skin is incised.[285]
  • Maintain therapeutic levels of the antimicrobial agent in both serum and tissues throughout the operation and until, at most, a few hours after the incision is closed in the operating room.[179,266-268,282,284,286] Because clotted blood is present in all surgical wounds, therapeutic serum levels of AMP agents are logically important in addition to therapeutic tissue levels. Fibrin-enmeshed bacteria may be resistant to phagocytosis or to contact with antimicrobial agents that diffuse from the wound space.

Table 4 summarizes typical SSI pathogens according to operation type and cites studies that establish AMP efficacy for these operations. A simple way to organize AMP indications is based on using the surgical wound classification scheme shown in Table 7, which employs descriptive case features to postoperatively grade the degree of intraoperative microbial contamination. A surgeon makes the decision to use AMP by anticipating preoperatively the surgical wound class for a given operation.

AMP is indicated for all operations that entail entry into a hollow viscus under controlled conditions. The most frequent SSI pathogens for such clean-contaminated operations are listed in Table 4. Certain clean-contaminated operations, such as elective colon resection, low anterior resection of the rectum, and abdominoperineal resection of the rectum, also require an additional preoperative protective maneuver called "preparation of the colon," to empty the bowel of its contents and to reduce the levels of live microorganisms. [200,239,256,268,284,287] This maneuver includes the administration of enemas and cathartic agents followed by the oral administration of nonabsorbable antimicrobial agents in divided doses the day before the operation.[200,288,289]

AMP is sometimes indicated for operations that entail incisions through normal tissue and in which no viscus is entered and no inflammation or infection is encountered. Two well-recognized AMP indications for such clean operations are: (1) when any intravascular prosthetic material or a prosthetic joint will be inserted, and (2) for any operation in which an incisional or organ/space SSI would pose catastrophic risk. Examples are all cardiac operations, including cardiac pacemaker placement,[290] vascular operations involving prosthetic arterial graft placement at any site or the revascularization of the lower extremity, and most neurosurgical operations (Table 4). Some have advocated use of AMP during all operations on the breast.[80,242,264]

By definition, AMP is not indicated for an operation classified in Table 7 as contaminated or dirty. In such operations, patients are frequently receiving therapeutic antimicrobial agents perioperatively for established infections.

Cephalosporins are the most thoroughly studied AMP agents.[284] These drugs are effective against many gram-positive and gram-negative microorganisms. They also share the features of demonstrated safety, acceptable pharmacokinetics, and a reasonable cost per dose.[242] In particular, cefazolin is widely used and generally viewed as the AMP agent of first choice for clean operations.[266] If a patient is unable to receive a cephalosporin because of penicillin allergy, an alternative for gram-positive bacterial coverage is either clindamycin or vancomycin.

Cefazolin provides adequate coverage for many clean-contaminated operations,[268,291] but AMP for operations on the distal intestinal tract mandates use of an agent such as cefoxitin (or some other second-generation cephalosporin) that provides anaerobic coverage. If a patient cannot safely receive a cephalosporin because of allergy, a reasonable alternative for gram-negative coverage is aztreonam. However, an agent such as clindamycin or metronidazole should also be included to ensure anaerobic coverage.

The aminoglycosides are seldom recommended as first choices for AMP, either as single drugs or as components of combination regimens.[242,264] References cited in Table 4 provide many details regarding AMP choices and dosages, antimicrobial spectra and properties, and other practical clinical information.

The routine use of vancomycin in AMP is not recommended for any kind of operation.[242,266,283,292] However, vancomycin may be the AMP agent of choice in certain clinical circumstances, such as when a cluster of MRSA mediastinitis or incisional SSI due to methicillin-resistant coagulase- negative staphylococci has been detected. A threshold has not been scientifically defined that can support the decision to use vancomycin in AMP. The decision should involve consideration of local frequencies of MRSA isolates, SSI rates for particular operations, review of infection prevention practices for compliance, and consultation between surgeons and infectious disease experts. An effective SSI surveillance program must be operational, with careful and timely culturing of SSI isolates to determine species and AMP agent susceptibilities.[80]

Agents most commonly used for AMP (i.e., cephalosporins) exhibit time-dependent bactericidal action. The therapeutic effects of such agents are probably maximized when their levels continuously exceed a threshold value best approximated by the minimal bactericidal concentration value observed for the target pathogens in vitro. When the duration of an operation is expected to exceed the time in which therapeutic levels of the AMP agent can be maintained, additional AMP agent should be infused. That time point for cefazolin is estimated as 3 to 4 hours. In general, the timing of a second (or third, etc.) dose of any AMP drug is estimated from three parameters: tissue levels achieved in normal patients by a standard therapeutic dose, the approximate serum half-life of the drug, and awareness of approximate MIC90 values for anticipated SSI pathogens. References in Table 6 should be consulted for these details and important properties of antimicrobial agents used for AMP in various specialties.

Basic "rules of thumb" guide decisions about AMP dose sizes and timing. For example, it is believed that a full therapeutic dose of cefazolin (1-2 g) should be given to adult patients no more than 30 minutes before the skin is incised.[242,285] There are a few exceptions to this basic guide. With respect to dosing, it has been demonstrated that larger doses of AMP agents are necessary to achieve optimum effect in morbidly obese patients.[293] With respect to timing, an exception occurs for patients undergoing cesarean section in whom AMP is indicated: the initial dose is administered immediately after the umbilical cord is clamped.[266,272,273] If vancomycin is used, an infusion period of approximately 1 hour is required for a typical dose. Clearly, the concept of "on-call" infusion of AMP is flawed simply because delays in transport or schedule changes can mean that suboptimal tissue and serum levels may be present when the operation starts.[242,294] Simple protocols of AMP timing and oversight responsibility should be locally designed to be practical and effective.


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