RESUMO
BACKGROUND: Antimicrobial prophylaxis reduces the incidence of postoperative wound infections especially among patients undergoing orthopedics surgery. However, there is dearth of information on the clinical effectiveness, spectrum limitations and practical contextual information on third and fourth generation cephalosporins. The aim of this study was to evaluate the efficacy and safety of cefepime and ceftriaxone as peri-operative systemic antimicrobial prophylaxis in elective orthopedic surgery in our center. METHODS: This study was a prospective, randomized, open label comparative clinical study of patients undergoing elective orthopedic procedures at the Bugando Medical Centre (BMC) between June 2014 and February 2015. Two hundred thirty participants were enrolled in the study and randomly assigned into Ceftriaxone regimen (group A) or Cefepime regimen (group B). Participants in ceftriaxone or cefepime group received 50 mg/kg up to 2 g single dose perioperative intravenous infusion at least 30 min before incision. Both groups were followed for 30 days using a Center for Disease Control superficial surgical site infection criterion for the outcome. A two-tailed margin of equivalence was set at 5% analyzed on the intent to treat. RESULTS: All 230 participants were subjected to final analysis with no patient being lost to follow-up. Superficial surgical site infection occurred in 5 out of 117 (4.3%, 0.6 to 7.9 at 95% CI) patients receiving cefepime compared to 3 out of 113 (2.7%, 0.3 to 5.6 at 95% CI) among patients receiving ceftriaxone regimen. The absolute difference of 1.6% (95% Confidence Interval: -6.3 to 3.1), equivocally lies outside the 5% statistically significant margin of presumed clinical equivalence. CONCLUSION: The difference between cefepime and ceftriaxone in preventing SSIs following elective clean orthopedic surgery was not statistically significant. TRIAL REGISTRATION: Pan African Clinical Trial Registry: PACTR201406000803420.