Abstract:

Background: Antimicrobial prophylaxis reduces the incidence of postoperative wound infections especially among patients undergoing orthopedic procedures, or those in which the consequences of infection are serious. So far, there is dearth of information on the clinical effectiveness, spectrum limitations and practical contextual information on third and fourth generation cephalosporins as generally used by the surgical fraternity at Bugando Medical Centre (BMC). The aim of this study was to evaluate the efficacy and safety of Cefepime and Ceftriaxone as perioperative systemic antimicrobial prophylaxis in elective orthopedic surgery in our local setting.

Methods: This study was a prospective, randomized, open label comparative clinical study of patients undergoing elective orthopedic procedures at Bugando Medical Centre (BMC) between June 2014 and February 2015. A total of 230 consented participants were enrolled in the study and were randomly assigned into Ceftriaxone regime (group A) or Cefepime regimen (group B). Participants in Ceftriaxone or Cefepime group received up to 2g ‘single dose’ perioperative intravenous infusion at least 15 minutes and optimally within 60 minutes before incision. Patients in both groups were followed up for 30 days using Centre for Disease Control (CDC) criterion on surgical site infections and used to delineate the primary outcome. Ethical approval was obtained from the Catholic University of Health and Allied Sciences (CUHAS-Bugando)/ Bugando Medical Centre (BMC) joint institutional ethics review committee and the study was registered with Cochrane Pan African Clinical Trial Registry before its commencement. A written informed consent for the study and for HIV testing was sought from patients. Data was collected using data sheets and analyzed using STATA software version 11.0 with help of a medical Statistician.