title: Cefepime versus Ceftriaxone for perioperative systemic antibiotic prophylaxis in elective orthopedic surgery at Bugando Medical Centre Mwanza, Tanzania: a randomized clinical study.
abstract: 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.
  
  
  CONCLUSIONS
  The difference between cefepime and ceftriaxone in preventing SSIs following elective clean orthopedic surgery was not statistically significant.
  
  
  BACKGROUND
  Pan African Clinical Trial Registry: PACTR201406000803420.
authors.affiliation: Department of Surgery, Catholic University of Health and Allied Sciences, Box 1464, Mwanza, Tanzania. makengem@yahoo.com.
authors.forename: Joel M
authors.initials: JM
authors.lastname: Marwa
authors.affiliation: Department of Trauma and Orthopedics, Bugando Medical Centre, Box 1370, Mwanza, Tanzania. ihngayomela@gmail.com.
authors.forename: Isidor H
authors.initials: IH
authors.lastname: Ngayomela
authors.affiliation: Department of Microbiology/Immunology, Catholic University of Health and Allied Sciences (CUHAS), P.O. BOX 1464, Mwanza, Tanzania. senijj80@gmail.com.
authors.forename: Jeremiah
authors.initials: J
authors.lastname: Seni
authors.affiliation: Department of Microbiology/Immunology, Catholic University of Health and Allied Sciences (CUHAS), P.O. BOX 1464, Mwanza, Tanzania. mshana72@yahoo.com.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Mshana
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D019072:Antibiotic Prophylaxis / Q000379:methods*; D001419:Bacteria / Q000145:classification / Q000187:drug effects / Q000302:isolation & purification; D000077723:Cefepime; D002443:Ceftriaxone / Q000008:administration & dosage / Q000627:therapeutic use*; D002511:Cephalosporins / Q000008:administration & dosage / Q000627:therapeutic use*; D017558:Elective Surgical Procedures / Q000379:methods*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000379:methods*; D019990:Perioperative Care; D011446:Prospective Studies; D013636:Tanzania; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D002443:Ceftriaxone; D000077723:Cefepime