SLR - April 2018 - Hyun W. Shim
Effect of Antibiotic Prophylaxis of Surgical Site Infections Following Removal of Orthopaedic Implants Used for Treatment of Foot, Ankle and Lower-Leg Fractures: A Randomized Clinical Trial
Reference: Backes, M, Dingemans SA, Dijkgraaf MGW, van den Berg HR, van Dijkman B, Hoogendoorn JM, Joosse P, Ritchie ED, Roerdink WH, Schots JPM, Sosef NL, Spijkerman IJB, Twigt BA, van der Veen AH, van Veen RN, Vermeulen J, Vos DI, Winkelhagen J, Goslings JC, Schepers T; WIFI Collaboration Group. Effect of Antibiotic Prophylaxis of Surgical Site Infections Following Removal of Orthopaedic Implants Used for Treatment of Foot, Ankle and Lower-Leg Fractures: A Randomized Clinical Trial. JAMA. 2017 Dec 26; 318 (24): 2438–2445.
Scientific Literature Review
Reviewed By: Hyun W. Shim, DPM
Residency Program: Temple University Hospital, Philadelphia, PA
Podiatric Relevance: As podiatric surgeons, we commonly encounter patients who require open reduction and internal fixation using metallic implants, as well as the subsequent removal of those implants. Although the reasoning behind the removal of implants varies, whether it was planned or caused a functional problem, removal of hardware is not a rarity in our field. When planning for hardware removal, prophylactic antibiotic use may be advocated by the surgeon to reduce the possibility of a surgical site infection. Although a common practice, there is insufficient data on the benefit of prophylactic antibiotic use on reducing surgical site infection following implant removal. This study analyzed patients who were randomly selected to either receive a prophylactic dose of Cefazolin in a bolus of sodium chloride or a bolus of sodium chloride. The study hypothesized that a single dose of prophylactic antibiotic would lower the rate of surgical site infection.
Methods: The study was a multicenter, double-blind, randomized clinical trial in which patients undergoing hardware removal were recruited. Of 500 patients recruited, 477 patients were included in the study. Two hundred thirty-two patients received the prophylactic antibiotic dose, and 245 patients received a bolus of saline. The primary outcome measure was the presence of a surgical site infection within 30 days of procedure. Each surgical site infection was classified as either superficial or deep. Secondary outcomes measured health-related quality of life (EuroQol five-dimension three-level questionnaire), functional outcome (Lower-Extremity Functional Scale) and patient satisfaction using visual analog scale. The groups received either the Cefazolin or bolus of sodium chloride 15 to 60 minutes prior to surgery in the preoperative holding area by the anesthesia team in the absence of the surgeon. The follow-up was conducted by a physician who was not part of the surgical team and was blinded to the treatment group.
Results: Of all the patients studied, 66 (14 percent) developed a surgical site infection, 30 (13.2 percent) from the Cefazolin group and 36 (14.9 percent) from the control group, with no statistically significant difference. However, it is noted that deep surgical site infection was more prevalent in the control group (seven in the control group vs. one in the Cefazolin group). Secondary outcomes analyzing health-related quality of life, visual analog scale and the lower-extremity functional scale were not statistically significantly different between the two study groups.
Conclusions: When analyzing the data, both the primary and secondary outcomes revealed that there is no statistically significant difference between the Cefazolin group and the control saline group. However, deep wound infections were more prevalent in the control saline group. Limitations of the study included the use of 1,000 mg of Cefazolin compared to the use of 2,000 mg of Cefazolin as advocated by recently published studies depending on patient’s weight, potential beneficial effect on preventing deep infections and selection bias. Both groups showed similar rates of surgical site infections, and therefore, the surgeon and the patient must understand the risks and benefits prior to removal of hardware.