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Guideline for Prevention of Surgical Site Infection, 1999

3. Operative characteristics: Intraoperative issues

a. Operating room environment

(1) 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.[295] 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.[233,237,296,297] In these outbreaks, the strain causing the outbreak was recovered from the air in the operating room.[237,296] It has been demonstrated that exercising and changing of clothing can lead to airborne dissemination of group A streptococci from vaginal or rectal carriage.[233,234,237,297]

Operating rooms should be maintained at positive pressure with respect to corridors and adjacent areas.[298] Positive pressure prevents airflow from less clean areas into more 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 the first filter bed being >30% and that of the second filter bed being >90%.[299] Conventional operating room ventilation systems produce a minimum of about 15 air changes of filtered air per hour, three (20%) of which must be fresh air.[299,300] Air should be introduced at the ceiling and exhausted near the floor.[300,301] Detailed ventilation parameters for operating rooms have been published by the American Institute of Architects in collaboration with the U.S. Department of Health and Human Services (Table 8).[299]

Laminar airflow and use of UV radiation have been suggested as additional measures to reduce SSI risk for certain operations. Laminar airflow is designed to move particle-free air (called "ultraclean air") over the aseptic operating field at a uniform velocity (0.3 to 0.5 μm/sec), sweeping away particles in its path. Laminar airflow can be directed vertically or horizontally, and recirculated air is usually passed through a high efficiency particulate air (HEPA) filter.[302,303] HEPA filters remove particles >0.3μm in diameter with an efficiency of 99.97%.[64,300,302,304] Most of the studies examining the efficacy of ultraclean air involve only orthopedic operations.[298,305-311] Charnley and Eftaknan studied vertical laminar airflow systems and exhaust-ventilated clothing and found that their use decreased the SSI rate from 9% to 1%.[305] However, other variables (i.e., surgeon experience and surgical technique) changed at the same time as the type of ventilation, which may have confounded the associations. In a multicenter study examining 8,000 total hip and knee replacements, Lidwell et al. compared the effects of ultraclean air alone, antimicrobial prophylaxis alone, and ultraclean air in combination with antimicrobial prophylaxis on the rate of deep SSIs.[307] The SSI rate following operations in which ultraclean air alone was used decreased from 3.4% to 1.6%, whereas the rate for those who received only antimicrobial prophylaxis decreased from 3.4% to 0.8%. When both interventions were used in combination, the SSI rate decreased from 3.4% to 0.7%. These findings suggest that both ultraclean air and antimicrobial prophylaxis can reduce the incidence of SSI following orthopedic implant operations, but antimicrobial prophylaxis is more beneficial than ultraclean air. Intraoperative UV radiation has not been shown to decrease overall SSI risk.[94,312]

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(2) Environmental surfaces

(2) Environmental surfaces Environmental surfaces in U.S. operating rooms (e.g., tables, floors, walls, ceilings, lights) are rarely implicated as the sources of pathogens important in the development of SSIs. Nevertheless, it is important to perform routine cleaning of these surfaces to reestablish a clean environment after each operation.[180,212,300,302] 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.[180,212,300-302,313-315] 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.[315] Wet-vacuuming of the floor with an EPA approved hospital disinfectant is performed routinely after the last operation of the day or night. Care should be taken to ensure that medical equipment left in the operating room be covered so that solutions used during cleaning and disinfecting do not contact sterile devices or equipment.[316] There are no data to support special cleaning procedures or closing of an operating room after a contaminated or dirty operation has been performed.[300,301]

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.[1,179,295,301]

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(3) Microbiologic sampling

Because there are no standardized parameters by which to compare microbial levels obtained from cultures of 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.

(4) Conventional sterilization of surgical instruments

Inadequate sterilization of surgical instruments has resulted in SSI outbreaks.[302,317,318] Surgical instruments can be sterilized by steam under pressure, dry heat, ethylene oxide, or other approved methods. The importance of routinely monitoring the quality of sterilization procedures has been established.[1,180,212,299] Microbial monitoring of steam autoclave performance is necessary and can be accomplished by use of a biological indicator.[212,314,319] Detailed recommendations for sterilization of surgical instruments have been published.[212,314,320,321]

(5) Flash sterilization of surgical instruments

The Association for the Advancement of Medical Instrumentation defines flash sterilization as "the process designated for the steam sterilization of patient care items for immediate use."[321] During any operation, the need for emergency sterilization of equipment may arise (e.g., to reprocess an inadvertently dropped instrument). However, flash sterilization is not intended to be used for either reasons of convenience or as an alternative to purchasing additional instrument sets or to save time. Also, flash sterilization is not recommended for implantable devices(*) because of the potential for serious infections.[314,320,321]

Flash sterilization is not recommended as a routine sterilization method because of the lack of timely biologic indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to operating rooms, and use of minimal sterilization cycle parameters (i.e., time, temperature, pressure).[319] To address some of these concerns, many hospitals have placed equipment for flash sterilization in close proximity to operating rooms and new biologic indicators that provide results in 1 to 3 hours are now available for flash-sterilized items.[322-325] Nevertheless, flash sterilization should be restricted to its intended purpose until studies are performed that can demonstrate comparability with conventional sterilization methods regarding risk of SSI. Sterilization cycle parameters for flash sterilization are shown in Table 9.

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b. 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,[75,181,326-330] few controlled clinical studies have evaluated the relationship between the use of surgical attire and SSI risk. Nevertheless, the use of barriers seems prudent to minimize a patient’s exposure to the skin, mucous membranes, or hair of surgical team members, as well as to protect surgical team members from exposure to blood and bloodborne pathogens (e.g., human immunodeficiency virus and hepatitis viruses).

(1) Scrub suits

Surgical team members often wear a uniform called a "scrub suit" that consists of pants and a shirt. Policies for laundering, wearing, covering, and changing scrub suits vary greatly. Some policies restrict the laundering of scrub suits to the facility, while other facilities have policies that allow laundering by employees. There are no wellcontrolled studies evaluating scrub suit laundering as an SSI risk factor.[331] Some facilities have policies that restrict the wearing of scrub suits to the operating suite, while other facilities allow the wearing of cover gowns over scrub suits when personnel leave the suite. The Association of Operating Room Nurses recommends that scrub suits be changed after they become visibly soiled and that they be laundered only in an approved and monitored laundry facility. [212] Additionally, OSHA regulations require that "if a garment(s) is penetrated by blood or other potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible."[315]

(2) Masks

The wearing of surgical masks during operations to prevent potential microbial contamination of incisions is a longstanding surgical tradition. However, some studies have raised questions about the efficacy and cost-benefit of surgical masks in reducing SSI risk.[328,332-338] Nevertheless, wearing a mask can be beneficial since it protects the wearer’s nose and mouth from inadvertent exposures (i.e., splashes) to blood and other body fluids. OSHA regulations require that masks in combination with protective eyewear, such as goggles or glasses with solid shields, or chinlength 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.[315] In addition, a respirator certified by the National Institute for Occupational Safety and Health with protection factor N95 or higher is required when the patient has or is suspected of having infectious tuberculosis.[339]

(3) Surgical caps/hoods and shoe covers

Surgical caps/hoods are inexpensive and reduce contamination of the surgical field by organisms shed from the hair and scalp. SSI outbreaks have occasionally been traced to organisms isolated from the hair or scalp (S. aureus and group A Streptococcus),[75,76] 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 to decrease bacteria counts on the operating room floor.[340,341] Shoe covers may, however, protect surgical team members from exposure to blood and other body fluids during an operation. OSHA regulations require that surgical caps or hoods and shoe covers or boots be worn in situations when gross contamination can reasonably be anticipated (e.g., orthopedic operations, penetrating trauma cases).[315]

(4) Sterile gloves

Sterile gloves are put on after donning sterile gowns. A strong theoretical rationale supports the wearing of sterile gloves by all scrubbed members of the surgical team. Sterile gloves are worn to minimize transmission of microorganisms from the hands of team members to patients and to prevent contamination of team members’ hands with patients’ blood and body fluids. If the integrity of a glove is compromised (e.g., punctured), it should be changed as promptly as safety permits.[315,342,343] Wearing two pairs of gloves (double-gloving) has been shown to reduce hand contact with patients’ blood and body fluids when compared to wearing only a single pair.[344,345]

(5) Gowns and drapes

Sterile surgical gowns and drapes are used to create a barrier between the surgical field and potential sources of bacteria. Gowns are worn by all scrubbed surgical team members and drapes are placed over the patient. There are limited data that can be used to understand the relationship of gown or drape characteristics with SSI risk. The wide variation in the products and study designs make interpretation of the literature difficult.[329,346-350]

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.[351,352] In general, only gowns reinforced with films, coatings, or membranes appear to meet standards developed by the American Society for Testing and Materials.[351-353] However, such "liquid-proof" gowns may be uncomfortable because they also inhibit heat loss and the evaporation of sweat from the wearer’s body. These factors should be considered when selecting gowns.[353,354] A discussion of the role of gowns and drapes in preventing the transmission of bloodborne pathogens is beyond the scope of this document.[355]

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c. Asepsis and surgical technique

(1) Asepsis

Rigorous adherence to the principles of asepsis by all scrubbed personnel is the foundation of surgical site infection prevention. Others who work in close proximity to the sterile surgical field, such as anesthesia personnel who are separated from the field only by a drape barrier, also must abide by these principles. SSIs have occurred in which anesthesia personnel were implicated as the source of the pathogen.[34,231,234,356-358] Anesthesiologists and nurse anesthetists perform a variety of invasive procedures such as placement of intravascular devices and endotracheal tubes, and administration of intravenous drugs and solutions. Lack of adherence to the principles of asepsis during such procedures, [359] including use of common syringes[360,361] and contaminated infusion pumps,[359,362-364] and the assembly of equipment and solutions in advance of procedures,[316,360] have been associated with outbreaks of postoperative infections, including SSI. Recommendations for infection control practices in anesthesiology have been published.[212,365-367]

(2) Surgical technique

Excellent surgical technique is widely believed to reduce the risk of SSI.[26,49,179,180,368,369] Such techniques include maintaining effective hemostasis while preserving adequate blood supply, preventing hypothermia, gently handling tissues, avoiding inadvertent entries into a hollow viscus, removing devitalized (e.g., necrotic or charred) tissues, using drains and suture material appropriately, eradicating dead space, and appropriately managing the postoperative incision.

Any foreign body, including suture material, a prosthesis, or drain, may promote inflammation at the surgical site94 and may increase the probability of SSI after otherwise benign levels of tissue contamination. Extensive research compares different types of suture material and their presumed relationships to SSI risk.[370-379] In general, monofilament sutures appear to have the lowest infectionpromoting effects.[3,94,179,180]

A discussion of appropriate surgical drain use and details of drain placement exceed the scope of this document, but general points should be briefly noted. Drains placed through an operative incision increase incisional SSI risk.[380] Many authorities suggest placing drains through a separate incision distant from the operative incision.[283,381] It appears that SSI risk also decreases when closed suction drains are used rather than open drains.[174] Closed suction drains can effectively evacuate postoperative hematomas or seromas, but timing of drain removal is important. Bacterial colonization of initially sterile drain tracts increases with the duration of time the drain is left in place.[382]

Hypothermia in surgical patients, defined as a core body temperature below 36°C, may result from general anesthesia, exposure to cold, or intentional cooling such as is done to protect the myocardium and central nervous system during cardiac operations.[302,383,384] In one study of patients undergoing colorectal operations, hypothermia was associated with an increased SSI risk.[385] Mild hypothermia appears to increase incisional SSI risk by causing vasoconstriction, decreased delivery of oxygen to the wound space, and subsequent impairment of function of phagocytic leukocytes (i.e., neutrophils).[386-390] In animal models, supplemental oxygen administration has been shown to reverse the dysfunction of phagocytes in fresh incisions.[391] In recent human experiments, controlled local heating of incisions with an electrically powered bandage has been shown to improve tissue oxygenation.[392] Randomized clinical trials are needed to establish that measures which improve wound space oxygenation can reduce SSI risk.

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4. Operative characteristics: Postoperative issues

a. Incision care

The type of postoperative incision care is determined by 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 second intention. When a surgical incision is closed primarily, as most are, the incision is usually covered with a sterile dressing for 24 to 48 hours.[393,394] Beyond 48 hours, it is unclear whether an incision must be covered by a dressing or whether showering or bathing is detrimental to healing. When a surgical incision is left open at the skin level 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). When such is the case, the incision is packed with a sterile dressing. When a surgical incision is left open to heal by second intention, it is also packed with sterile moist gauze and covered with a sterile dressing. The American College of Surgeons, CDC, and others have recommended using sterile gloves and equipment (sterile technique) when changing dressings on any type of surgical incision.[180,395-397]

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b. Discharge planning

In current practice, many patients are discharged very soon after their operation, before surgical incisions have fully healed.[398] The lack of optimum protocols for home incision care dictates that much of what is done at home by the patient, family, or home care agency practitioners must be individualized. The intent of discharge planning is to maintain integrity of the healing incision, educate the patient about the signs and symptoms of infection, and advise the patient about whom to contact to report any problems.

* 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." [321]

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