To Scip … or Not to Scip … the Surgical Care Improvement Project Protocol

Reducing the incidence of surgical-site infection is a priority, goal, and challenge for all surgeons. To minimize surgical-site infection, surgeons have relied on a variety of techniques such as copious irrigation, meticulous technique, absolute sterility, and antibiotics. Surgeons have routinely prescribed preoperative and postoperative antibiotics based on common causative organisms. The duration of antibiotic therapy is variable and usually based on the specific procedure performed. Most surgeons have justified specific antibiotic protocols based on traditional recommendations, judgment, and experience. There are few randomized prospective studies that have validated individual practice patterns. The injudicious use of antibiotics has caused concern in the world of infectious disease. The number of bacteria that are resistant to antibiotics is increasing. In addition, the costs associated with indiscriminate antibiotic prophylaxis are increasing. To date, there has been no consensus regarding the administration or duration of antibiotic therapy. In a recent survey of 650 plastic surgeons, 98 percent used preoperative intravenous antibiotics, 72 percent used postoperative oral antibiotics, and 46 percent discontinue antibiotics when the drain is removed.1 The lack of a standardized algorithm has prompted the need for evidence-based justification regarding antibiotic use and duration in the setting of elective surgery. The Surgical Care Improvement Project was initiated in 2003 by the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention. It was implemented in 2005 and adopted by many hospital centers throughout the United States. Its goal was to reduce the incidence of surgical-site infection by 25 percent by the year 2010. There are seven quality improvement measures designed to reduce the incidence of surgical-site infection (Table 1). Of these seven, three are relevant to this Editorial and include antibiotic selection, timing of initial antibiotic administration, and timing for discontinuation of antibiotic therapy.Table 1: The Seven Surgical Care Improvement Project Quality Control MeasuresThe Surgical Care Improvement Project quality improvement measures were based on several controlled studies. One such study was based on elective colorectal procedures and demonstrated that the incidence of surgical-site infection was significantly higher when prophylactic antibiotics were not administered within 1 hour of incision.2 This finding was more important than the choice of prophylactic antibiotic. In addition, surgical-site infection was not related to the duration of postoperative antibiotic therapy. Based on the results of studies such as this, Surgical Care Improvement Project quality measures have been adopted by many hospitals, for most surgical specialties, and for most surgical procedures. Since the implementation of the Surgical Care Improvement Project quality measures, concerns regarding efficacy have been raised. In a retrospective cohort study, Stulberg et al. reviewed data on 405,720 patients discharged from 398 U.S. hospitals for which Surgical Care Improvement Project performance was recorded.3 Of 3996 documented infections, the authors were not able to demonstrate a statistically lower probability of infection based on individual process-of-care Surgical Care Improvement Project measures. The reasons for this were presumed to be because of the many “other factors” that predisposed to infection that were not included in the core measures. Hawn has also opined, based on review of current evidence, that the Surgical Care Improvement Project quality measures have not improved surgical outcomes.4 These general observations have led many plastic surgeons to inquire about the efficacy of the Surgical Care Improvement Project quality measures in very specific situations, namely, reconstructive breast surgery with or without prosthetic devices. Patients in this category may be at increased risk for surgical-site infection based on other factors that include but are not limited to cancer immunosuppression, placement of prosthetic materials, prior irradiation, and poorly vascularized mastectomy skin flaps.5,6 Three relevant studies have been identified, of which one is supportive of the Surgical Care Improvement Project protocol and the other two are not. In the sole supportive study, Throckmorton et al. demonstrated no difference in surgical-site infection between patients following elective breast surgery in which the Surgical Care Improvement Project protocol was or was not followed.7 The majority of patients in this study did not have breast reconstruction. Of the two nonsupportive studies, Berhane et al. demonstrated that following prosthetic reconstruction with acellular dermal matrix, the incidence of surgical-site infection was 31.3 percent when only intravenous antibiotics were administered.8 When oral antibiotics were added for 48 hours or for greater than 48 hours, the incidence of surgical-site infection was reduced to 8.4 and 3.3 percent respectively. In the second study, Clayton et al. demonstrated that rates of surgical-site infection and reoperation were significantly increased when Surgical Care Improvement Project measures were followed compared with when they were not in the setting of prosthetic breast reconstruction with acellular dermal matrix.9 It was concluded that withholding postoperative antibiotics was associated with an increased risk of surgical-site infection, reoperation, and reconstructive failure. The results of these studies are clearly a cause for concern and warrant explanation. First, the normal breast parenchyma is not sterile and may yield positive microbial cultures in 40 percent of patients.10 Second, the vascularity of the remaining mastectomy skin flaps is often compromised. This can result in delayed healing that can serve as a nidus for infection. Third, the placement of a foreign body (i.e., tissue expander or implant) can further complicate matters because of the ensuing foreign body reaction and pressure exerted on the mastectomy skin flaps. Finally, the use of an acellular dermal matrix must be considered because it is a foreign material that is associated with a mild to moderate inflammatory response.11 This inflammation can manifest as redness with a physical appearance that mimics cellulitis. Based on these factors, the following recommendations are proposed. In the setting of mastectomy and prosthetic reconstruction with or without acellular dermal matrix, the duration of prophylactic oral antibiotics should be based on the surgeon's discretion. In some cases, there may be no need for postoperative oral antibiotics such as in the setting of prophylactic mastectomy with thick skin flaps, good vascularity, and low risk of surgical-site infection. However, in cases at higher risk for surgical-site infection, a 1- to 2-week course of oral antibiotics may be useful. It is not logical to mandate that all patients and all surgical procedures should be managed equally when it comes to antibiotic prophylaxis. Keep in mind that surgical-site infection is associated with additional morbidity, prolonged hospitalizations, further surgery, reconstructive failure, and increased cost. The financial burden to hospitals and the health care system is real and cannot be ignored. Olson et al. have calculated that patients developing surgical-site infection following breast surgery had crude median costs of $16,882 compared with $6123 for patients without surgical-site infection.12 In summary, it is this surgeon's opinion that the duration of prophylactic antibiotic therapy should be based on patient risk factors and on the specific operation being performed. Universal precautions to minimize the incidence of surgical-site infection in the setting of mastectomy and reconstruction should include repeated preparation and draping, use of new surgical instruments, minimal handling of the prosthetic and bioprosthetic devices, appropriate use of preoperative intravenous antibiotics, and appropriate use of postoperative oral antibiotics when indicated. Maurice Y. Nahabedian, M.D. Department of Plastic Surgery Georgetown University Hospital 3800 Reservoir Road, NW Washington, D.C. 20007 [email protected]