BACKGROUND: Antimicrobial prophylaxis reduces the incidence of postoperative wound @entity281 especially among @entity1 undergoing orthopedics surgery. However, there is dearth of information on the clinical effectiveness, spectrum limitations and practical contextual information on third and fourth generation @entity2886 . The aim of this study was to evaluate the efficacy and safety of @entity6944 and @entity2756 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 @entity1 undergoing elective orthopedic procedures at the Bugando Medical Centre (BMC) between June 2014 and February 2015. Two hundred thirty @entity1 were enrolled in the study and randomly assigned into @entity2756 regimen (group A) or @entity6944 regimen (group B). @entity1 in @entity2756 or @entity6944 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 @entity281 criterion for the outcome. A two-tailed margin of equivalence was set at 5  % analyzed on the intent to treat. RESULTS: All 230 @entity1 were subjected to final analysis with no @entity1 being lost to follow-up. Superficial @entity281 occurred in 5 out of 117 (4.3  %, 0.6 to 7.9 at 95  % CI) @entity1 receiving @entity6944 compared to 3 out of 113 (2.7  %, 0.3 to 5.6 at 95  % CI) among @entity1 receiving @entity2756 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 @entity6944 and @entity2756 in preventing SSIs following elective clean orthopedic surgery was not statistically significant. TRIAL REGISTRATION: Pan African Clinical Trial Registry: PACTR201406000803420.

XXXX versus @entity2756 for perioperative systemic antibiotic prophylaxis in elective orthopedic surgery at Bugando Medical Centre Mwanza, Tanzania: a randomized clinical study.

@entity1 :: ('9606', 'Species') :: ['participants', 'patients', 'patient', 'Participants'] @entity2756 :: ('MESH:D002443', 'Chemical') :: ['Ceftriaxone', 'ceftriaxone'] @entity6944 :: ('MESH:C043266', 'Chemical') :: ['Cefepime', 'cefepime'] @entity2886 :: ('MESH:D002511', 'Chemical') :: ['cephalosporins'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infections', 'surgical site infection']
@entity6944 :: (MESH:C043266,Chemical) :: ['Cefepime']
