Antimicrobial prophylaxis in laparotomic gynecologic surgery: a prospective randomized study comparing amoxicillin-clavulanic acid with cefazolin.

A prospective randomized study was conducted at the Department of Obstetrics and Gynecology, University of Bari to compare two antimicrobial regimens, amoxicillin-clavulanic acid with cefazolin as ultra-short term prophylaxis in laparotomic gynecologic surgery. Patients were randomly allocated to receive a single dose of amoxicillin-clavulanic acid (2.2 g) [Group A] or cefazolin (2 g) [Group B] 30 minutes before surgery. Each patient was assessed daily until discharge for fever and the presence of infection of the surgical wound, urinary tract and respiratory tract. In the amoxicillin-clavulanic acid (Group A) and cefazolin (Group B) groups, overall 258 and 253 patients, respectively were evaluable for prophylactic efficacy at hospital discharge. Infectious complications were infrequent in both arms. Febrile morbidity occurred in 16 (6.3%) and 21 (8.1%) patients respectively in the amoxicillin-clavulanic acid and cefazolin groups. Wound infection and urinary tract infection were also higher but not significantly in the cefazolin group (0.8% versus 0% and 2.7% versus 2.0% respectively). There was no respiratory tract infection or septic death in either group. It is concluded that ultra-short term prophylaxis with both amoxicillin-clavulanic acid and cefazolin is safe and effective in elective laparotomic gynecologic surgery.

RCT Entities:   Population Interventions Outcomes