Prevention of Operative Infections: An Evidence-Based Approach




Summary of Key Points





  • Although most surgeons understand the importance of sterile technique in preventing surgical site infections, other steps can be taken before, during, and after the procedure to reduce the risk.



  • Thorough preoperative evaluation, including nasal S. aureus carrier testing, and nutritional assessment of at-risk individuals can lower the risk of surgical site infection (SSI).



  • Appropriate timing and selection of antibiotics are important factors.



  • Maintaining normothermia throughout the operation lowers the risk of SSI.



  • Tight postoperative blood glucose control lowers the risk of infectious complications.



  • Practicing surgeons should be familiar with publications by the Association of periOperative Registered Nurses and the U.S. Centers for Disease Control and Prevention, which carry further recommendations for reducing the risk of SSI.



Surgical site infections (SSIs) are a known problem in spine surgery. According to the National Healthcare Safety Network (NHSN), they complicate up to 2.3% of laminectomies, 4.15% of fusion procedures, and 8.73% of revision fusion operations. These rates vary, depending on patient risk factors (more on this later) and hospital-related factors. They may even be higher in some circumstances. In general, an SSI is associated with a twofold increase in mortality rate, as well as an increase in the likelihood that a patient will require readmission to the hospital or treatment in the intensive care unit. The length and cost of the hospital stay are increased as well.


Clearly, the best treatment for SSIs is prevention. Although most surgeons first think of sterile technique, other factors must be optimized as well, including those intrinsic to the patient, anesthetic factors, and perioperative medical management.


Most SSIs are caused by the patient’s normal skin flora ( Staphylococcus species being the most common). This is true for spine surgery too and is an important concept for the prevention of SSIs. The keys to prevention include reduction of the bacterial burden in the wound, minimization of patient-related factors that contribute to SSIs (e.g., hyperglycemia, hypothermia), and optimization of patient nutrition and baseline health status preoperatively.


This chapter is structured in chronologic order, with emphasis at steps that can be taken preoperatively, during the procedure, and postoperatively. First, however, it is worth noting the risk factors identified in the NHSN data: duration of operation greater than the 75th percentile, contaminated or dirty wound, and a patient American Society of Anesthesiologists (ASA) score of 3 or higher. Whereas the latter two are generally out of the surgeon’s control, the first is not. Care should be taken to minimize operative time, as longer duration carries a higher risk of SSI.




Preoperative Factors


Several factors can influence the risk of SSIs long before the patient enters the operating room. They warrant careful attention in the office.


Nutrition


More has been reported about the relationship between infection and nutrition in the general surgery and critical care literature than in the spine literature. Often such studies involve polytrauma and burn victims in severe catabolic states. However, the principles involved apply to elective spine surgery as well.


A study by Klein and coworkers followed three groups of patients and analyzed infections and other complications against markers of nutritional status. Patients were deemed nutritionally replete if they had a serum albumin of at least 3.5 g/dL and an absolute lymphocyte count (a stable immune marker) of at least 1500 cells/mm 3 . Patients falling below either or both of these cutoffs were considered malnourished.


In a group of 114 patients undergoing elective spinal procedures, 85 were found to be replete prior to surgery, and 29 were malnourished. The former group had a total of 2 complications, and the latter 11, a difference that is even more dramatic considering the disparate sizes of the groups. Of note, the researchers found that 40% of patients older than 60 years were malnourished. They found similar results among patients who were operated on for spondylodiscitis as well as spinal cord injury.


Considering the aforementioned results, a reasonable nutrition assessment and management approach would be to check serum albumin and absolute lymphocyte counts preoperatively, especially in older patients. If abnormal, surgery should be deferred until a nutrition consult is obtained and the patient is nutritionally replete.


Antiseptic Shower


Some have advocated the use of antiseptic showers, either with povidone-iodine (Betadine) or with chlorhexidine gluconate (CHG). A study of 700 surgical patients demonstrated a reduction of bacterial skin colonization with either soap, by a factor of 1.3-fold with iodine and 9-fold with CHG. Similar results have been found elsewhere. Although evidence to support a clear reduction in SSIs is lacking, a bottle of CHG solution sufficient for two preoperative showers costs about $9 US at the time of this writing, and its use is likely of great enough benefit to offset that minor cost. Thus, on the basis of a strong theoretic rationale and middling clinical evidence, the practice should be considered.


Mupirocin Nasal Ointment


Staphylococcus aureus is the leading cause of SSIs in clean surgical procedures, including spinal operations. An association has been noted between nasal carriage of S. aureus in patients and the occurrence of SSIs. About 30% to 35% of people in the United States are nasal carriers of S. aureus at any given time. A short course of treatment with mupirocin (Bactroban) ointment has been shown to eliminate S. aureus in many of these carriers, who can be identified by nasal testing.


Two earlier randomized control trials (RCTs) were conducted to evaluate the efficacy of preoperative mupirocin ointment usage in reducing SSI rates. Both studies showed a trend toward efficacy, but neither was significant. A later analysis showed that pooling the results revealed a nearly significant decrease in the infection rate. However, when all nosocomial S. aureus infections (not just SSIs) among patients with nasal S. aureus were considered, the study from Perl and associates did show a statistically significant decrease in incidence with the use of mupirocin ointment.


A subsequent RCT published in the New England Journal of Medicine assessed patients being admitted to the hospital for nasal S. aureus carriage by means of a polymerase chain reaction (PCR). Study group patients testing positive were treated with nasal mupirocin ointment twice daily and CHG baths daily for 5 days. This resulted in a significantly lower overall S. aureus infection rate and a lower rate of deep SSI in the study group when compared with the controls.


At this point, there is sufficient evidence to advocate the routine testing of patients for nasal S. aureus carrier status prior to elective surgical interventions and to treat carriers with nasal mupirocin with the possible addition of CHG showers.


Hair Removal


Historically, one of the most ingrained practices in all of surgery has been shaving the skin prior to an operation. Unfortunately, it is probably also detrimental. Removing hair by shaving with a razor has been compared with the use of electric clippers in three RCTs. These trials were similar in design and focused on clean operations (general and cardiac procedures), so their results were pooled in a Cochrane review. This yielded a total of 3193 patients, divided nearly evenly between shaving (1627) and clipping (1566). The infection rate was 2.8% for the former group, and 1.4% for the latter, yielding a relative risk (RR) of 2.02, which surpassed statistical significance.


In addition to this strong evidence against shaving, two other points can be made. First, there is no good evidence to show that hair removal lowers the infection rate. The step may be omitted entirely. Second, depilatory creams have been associated with a lower infection rate than shaving in several trials ; this provides another alternative to razors should complete hair removal be desired. Razors should only be used for hair removal with the clear understanding that their use has been associated with higher infection rates in several large, well-designed trials.


Skin Preparation


The rationale for preparing the skin prior to incision is twofold. First, the mechanical scrubbing of the skin removes dirt, as well as some bacteria and dead skin cells. Second, the prep solution should have an intrinsic bactericidal or bacteriostatic effect.


Commonly employed agents contain alcohol (isopropyl or ethyl), CHG, or iodine/iodophors. Alcohol has excellent activity against bacteria and good activity against mycobacteria, fungi, and viruses. However, it cannot be used alone because it has essentially no residual activity once allowed to evaporate. Prior to evaporation it is flammable, which makes it incompatible with electrocautery.


CHG has good to excellent activity against bacteria and viruses. It is fair at eliminating fungi and has little activity against mycobacteria. Its residual activity is excellent; however, it can cause keratitis and ototoxicity with serious consequences.


Triclosan (the active ingredient in dishwashing detergent) and parachlorometaxylenol (PCMX) are less efficacious and are generally considered less suitable for use in skin preparation or as surgical hand scrubs.


Given the clinical limitations of other preparations, CHG and iodophor solutions are most commonly used as surgical skin preps. CHG has been shown to reduce bacterial skin colonization to a greater degree than iodophors (see the prior section), but no evidence yet demonstrates a lower SSI rate when using CHG in spine procedures.


Nevertheless, in a large RCT, CHG has been shown to reduce the line infection rate when compared with iodophor prep in the placement of central venous catheters. A similar level of evidence does not yet exist for CHG as a surgical skin prep, but it is logical to expect that the superiority of CHG would hold true here as well. Thus, favoring CHG as a wet skin prep is advisable, provided there is no risk of the solution entering the eyes or ears.


More recently, two single-step skin prep solutions have become more popular: DuraPrep (3M, St. Paul, MN), a combination of iodine povacrylex and isopropyl alcohol, and ChloraPrep (CareFusion, San Diego, CA), which contains CHG and isopropyl alcohol. Both meet the Association of periOperative Registered Nurses (AORN) and U.S. Centers for Disease Control and Prevention (CDC) guidelines for reduction of SSI, but there is insufficient evidence to recommend one over the other. It is worth noting that the package insert for Chloraprep advises against its use for lumbar puncture or in contact with the meninges, so this must be taken into account when deciding.


Handwashing


Several options exist here as well. Iodophor and CHG solutions are available and are commonly used with scrub brushes for a specified period of time. A 10-minute period has been traditional, but there is no evidence to support this ritual; the CDC recommends a duration of 2 to 5 minutes.


In addition, waterless hand cleansers have recently come into more widespread use. Typical of these is Avagard (3M, St. Paul, MN). It consists of ethyl alcohol 61% w/w, CHG 1%, and a mixture of skin conditioners and fragrances.


Another category of hand cleaners includes water-aided, brushless formulations. Triseptin (Healthpoint Ltd., Fort Worth, TX) is one of these preparations. It also contains ethyl alcohol 61% w/w, as well as a proprietary formulation of conditioners and fragrances. A large RCT has demonstrated the equivalence of an aqueous alcohol-based hand rub with traditional handwashing techniques ; the results of this trial can safely be extrapolated to the products available on the U.S. market.


Because most SSIs arise from the patient’s skin flora, the use of one type of hand cleanser over another is largely left to individual preference. If there is a difference among the different agents available, it is likely quite small and has yet to be proved. Guidelines from the CDC regarding this choice are available.


First, artificial nails should be avoided. They can harbor microorganisms and predispose gloves to tearing. A series of Serratia marcescens wound infections have been traced to a surgical team member with artificial nails. Second, fingernails should be kept short and neat. Third, cleaning under the nails is recommended, as is removal of jewelry on the hands and arms, but the scientific support for this practice is overshadowed by the clear theoretic basis on which these recommendations are founded.


Surgical Gowns


The U.S. Occupational Safety and Health Administration (OSHA) requires that gowns have a minimum level of strikethrough resistance. All of the commercially available, disposable surgical gowns in the United States meet this standard. Porous cloth gowns have generally been eliminated because they do not offer this protection to the patient or to the surgeon.


Some have recommended that gowns and gloves be changed every 1.5 to 2 hours during lengthy cases. Although this recommendation is sensible, the cost of this practice must also be considered.


Double Gloving


The practice of double gloving has been advocated as a protection to both the medical staff and the patient. For the staff, the risk of transmitting a communicable disease, such as HIV or hepatitis, is likely reduced, as is the risk of gross contamination through a compromised glove. Not only is it more difficult to perforate two gloves than one, but in the event of a needlestick, the “squeegee effect” of the second glove has been shown as well.


Double gloving may reduce the risk of SSI as well. Perforation rates of greater than 20% have been reported for the primary operator. This puts the surgeon’s skin in direct contact with the surgical bed, increasing the chance of bacterial contamination for the patient and creating a hazardous exposure for the surgeon.


Although the superiority of double gloving in prevention of SSI has not been shown, a perusal of a Cochrane review reinforces the theoretic benefit of double gloving to the patient. When studying the risk of perforation of the inner glove (which is the only glove for single-gloved surgeons, and the inner for those double gloving), there is a clear trend across the 18 studies reviewed toward a lower likelihood of perforation for those who were double gloved.


It is important to remember here the axiom that the absence of proof of a benefit is not proof of absence of said effect. In addition to middling clinical evidence, there is a strong theoretic rationale for double gloving to protect the surgeon and the patient. The cost is minimal, and the potential benefits to all parties are significant.




Intraoperative Factors


Antimicrobial Adhesive Drapes


Antimicrobial adhesive drapes, such as Ioban (3M), are commonly used. These consist of an adhesive-backed plastic film that is impregnated with an iodine-containing compound. They have been shown to reduce bacterial contamination of wounds but have not reduced SSI rates in a prospective trial. However, because of their insignificant cost (about $7 US), their use remains at the discretion of the surgeon.


Antibiotic Prophylaxis


The cornerstone for antibiotic prophylaxis is the assumption that every wound will be contaminated by skin flora. The goal is to reduce bacterial contamination to levels that can more easily be eradicated by host defenses. Although debate continues regarding the role of antibiotic prophylaxis in clean soft tissue surgery, there is general agreement that it is indicated whenever bone is incised or hardware is implanted, or when SSI would pose catastrophic risk; these criteria neatly circumscribe spine surgery.


Timing and route of administration should follow the tenet of providing a tissue concentration of antibiotic that is greater than the minimum bactericidal concentration (MBC) of the organisms most likely to cause infection (i.e., Staphylococcus spp.) at the time of incision and maintaining the same until the skin is closed. A first-generation cephalosporin (usually cefazolin) is most often given. Peak serum concentration of cefazolin, when given intravenously, is achieved within 5 minutes. The half-life is 1.5 to 2.5 hours; however, with doses commonly given (1 to 2 g), the MBC is generally maintained for 4 hours or more. Based on this factor, redosing cefazolin every 4 hours during the operation is indicated. This regimen also provides for adequate concentrations of cefazolin in clotted blood that remains in the surgical bed postoperatively. Patients allergic to penicillins may require vancomycin or clindamycin for prophylaxis. Vancomycin is also recommended by the CDC if a cluster of infections due to methicillin-resistant organisms is detected; however, no scientific cutoff has been determined for this application, and its routine use as prophylaxis is discouraged.


Antibiotic prophylaxis, according to the guidelines of the CDC and others, should be continued throughout the operation, but should be terminated not more than 24 hours postoperatively. It is important to remember that the use of prophylactic antibiotics can be associated with infectious complications and Clostridium difficile colitis. There is no good evidence to support the practice of “drain prophylaxis” or the continuation of antibiotics until surgical drains have been removed.


Core Body Temperature


Maintenance of normothermia during a surgical procedure is perhaps one of the most important tools in preventing SSI. Hypothermia is easily caused by the combination of general anesthesia, patient exposure, and a cold operating room.


Hypothermia can cause impaired immune function, including reduced antibody production, decreased chemotaxis, and phagocytosis. Kurz and associates conducted an RCT of 200 patients undergoing major colon surgery. Core body temperature was allowed to trend downward in the control group ( n = 96; mean, 34.7° C) and maintained with warmed fluids and forced warm air heating blankets in the experimental group ( n = 104; mean, 36.6° C). The infection rate in the former was 18.8% compared with 5.8% in the latter, a significant difference. Additionally, the normothermic patients tolerated solid food sooner, were discharged earlier, and had greater collagen deposition in the wound. Several other studies were not nearly as well designed but showed similar results.


It is incumbent on the surgical team to assist the anesthesiologist in maintaining normothermia throughout the case. Anecdotally, it seems easier to maintain temperature than it is to warm up an anesthetized patient who has been allowed to become hypothermic. This can generally be accomplished by keeping the patient covered until skin prep and the operating room warm until the drapes and warm air blankets are applied.


Intraoperative Hyperoxygenation


Providing hyperoxygenation during an operation has been studied as a possible means of reducing SSIs. The theoretic backing is strong; however, the clinical evidence is mixed, and prolonged hyperoxia is known to have detrimental effects.


The rationale for hyperoxygenation is based on the positive role of oxygen in both the immune system and wound healing. Superoxide radicals are generated by neutrophils to carry out nonspecific killing, which is the body’s first line of defense against microorganisms. An increase in the arterial partial pressure of oxygen, P a o 2 , should lead to a subsequent increase in the tissue partial pressure of oxygen, P t o 2 . Furthermore, an increase of P t o 2 should lead to optimal collagen formation via the increased activity of prolyl hydroxylase.


In experimental studies, the role of operative hyperoxia has proved uncertain. Greif and colleagues studied 500 patients undergoing major colorectal procedures. Oxygen was administered at the fraction of inspired oxygen, F i o 2 = 0.3 (control) or 0.8 (experimental). This was continued throughout the procedure and for 2 hours postoperatively. The infection rate in the hyperoxic group was 5.2%, compared with 11.2% in the control group.


These results have yet to be repeated in a study of similar size and design. In another study of 160 patients, Pryor and coworkers found the infection rate of the hyperoxic group to be 25%, compared with 11% in the control group. This is the opposite of what the earlier study showed and what would be predicted theoretically. However, this study’s design has been criticized on several grounds, including the small sample size and some significant differences between the control and experimental groups. Several further studies have added conflicting results to the body of literature.


At this point, the role of hyperoxygenation in preventing SSI is far from clear, so the practice cannot be recommended.


Surgical Drains


Few subjects spark as much controversy among surgeons as the use of surgical drains. Advocates point out the theoretic basis that drains remove blood (itself an excellent culture medium), remove bacteria, and prevent hematoma formation. Opponents cite local immunosuppression and the role of drains as a conduit for bacteria.


At all events, no convincing evidence proves that drains alter the infection rate, one way or the other, in spine surgery. There is some argument from other disciplines that drains can increase the infection rate, at least drains of the open variety (i.e., Penrose). However, this must be taken with a grain of salt, as direct interdisciplinary comparisons cannot necessarily be made.


General surgeons and others who work in the abdomen and pelvis are afforded several luxuries that are not available to spine surgeons. First, they generally work in well-defined tissue planes. This is not the case with dorsal approaches to the spine, which involve a subperiosteal dissection. Second, their dissections along clean tissue planes allow for optimal hemostasis. In the case of spine surgery, incised bone always bleeds, and muscle often does. Third, a hematoma of 200 mL in the peritoneum or retroperitoneum is a nonevent. This is hardly the case for a hematoma of similar size in a subfascial laminectomy bed.


Because of the inherently low infection rate in spine surgery, and the likely minimal impact of drains on the infection rate, the number of patients needed for an RCT is substantial. Illustrative of this point is an article by Brown and Brookfield. Eighty-three patients were enrolled and underwent lumbar procedures “larger than single-level unilateral decompressions.” Drain placement was randomized. However, there were no infections. In fact, the only significant result was a higher temperature on postoperative day 1 in the drained group. The significance of this result is unclear. In their discussion, the investigators eloquently summarized the reason definitive evidence for or against the use of drains in spine surgery is unlikely: “We used data on rates of infection from previously published drain studies to estimate the sample size necessary to achieve a power of 0.80. Based on these numbers, it was determined that 9539 patients would have to be randomized into two groups to determine a true statistically significant difference. We discontinued the study after enrolling a more realistic sample size of 83 patients.”


The most reasonable alternative, and the place where the spine community should look for answers to this question, is probably the orthopaedic literature, especially that related to total joint arthroplasty. Similarities include the need to dissect through muscle, the necessary incision of bone in every case, similar blood loss, and the implantation of hardware.


In a meta-analysis of RCTs in the orthopaedic literature, 3689 wounds were studied in 3495 patients. All patients underwent total hip or knee arthroplasty, and the groups were evenly divided with regard to drain placement. Although there was a trend toward lower infection rates in the group with drains, it was not significant. What was significant, however, was an increased transfusion requirement in the drained patients.


Any good evidence for or against drains is offset by the evidence on the other side of the argument. However, general words of caution always apply. Drains are not a substitute for good hemostasis. They should not be left as a matter of routine but should be used when indicated. And if drains are employed, one should realize that the studies cited here all utilized closed-suction–type drains, and the results likely do not apply to open (i.e., Penrose) drains.


Vancomycin Powder in the Surgical Bed


The application of vancomycin powder directly to the surgical site, at the end of the operation, has gained some popularity. The theoretic rationale for this is sound, as vancomycin is a powerful, broad-spectrum antibiotic, and applying it directly to the surgical site would be expected to result in a higher local concentration, for a longer period of time, when compared to parenteral administration.


Indeed, several studies have shown a significant reduction in surgical site infections using this technique, when compared with historical controls (Strom, Sweet, O’Neill). However, several other studies have failed to show any benefit (Martin, Tubaki). The practice appears to be safe, although there is at least one report of a patient suffering systemic circulatory collapse, presumably due to an anaphylactic reaction (Mariappen). This reinforces the tenet that medications administered on the surgical field are delivered systemically.


At this point, the authors cannot recommend this as a routine practice, due to the lack of any prospective studies to support it, and some conflicting evidence of benefit in the existing, retrospective studies. However, it should be considered as an option, especially if a particular procedure or institution carries an increased risk of infection, as there is some evidence to support the practice, and it appears to be safe.


Operating Room Hygiene


In the United States, the design of operating rooms, including size, layout, and air-handling systems, is dictated by the recommendations of the American Institute of Architects. Surgeons have little control over these factors. They can, however, control what happens inside the operating room, and they can empower the operating room staff to exert such control as well. Much of what we do is dictated by expert opinion and tradition. We should not expect any more solid evidence to support this practice, as the ethical justification for such scientific trials would be suspect, at best. Summarized here are some of the protocols that are violated most frequently.


Traffic should be kept to a minimum during a procedure. Although the surgeons are generally present in a case for the duration, this is not true of the others in the room. Allowing breaks for the scrub and circulating nurses and the anesthetist is a matter of established routine, but it still increases traffic flow into and out of the operating room. To be avoided is the practice of a person entering the room to ask if breaks are desired. This can be accomplished by use of the telephone. Certainly the restocking of surgical and anesthetic supplies should not take place during a case.


AORN maintains a list of operating room standards and recommendations. This set of clear, straightforward guidelines should be familiar to all practicing surgeons. Among other things, they advise against covering sterile fields. This is because the cover can create air currents during removal, which could carry bacteria or contaminants onto the field and also because nonsterile parts of the cover may brush against the field during removal.


One of the most important aspects is maintenance of the sterile field. AORN recommends a boundary of 12 inches between nonsterile personnel and the sterile field; asking for a greater distance in order to achieve the specified 12 inches seems a perfectly reasonable approach.

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Feb 12, 2019 | Posted by in NEUROSURGERY | Comments Off on Prevention of Operative Infections: An Evidence-Based Approach

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