Comparison of the antimicrobial prophylactic efficacy of cefotaxime and cephazolin in obstetric and gynaecological surgery. A randomised multicentre study.

A prospective randomised multicentre study was designed to assess the efficacy of 2 different cephalosporins as short term prophylactic treatment in obstetric and gynaecological surgery. A single dose of cefotaxime (2g IV before surgery) was compared with 2 doses of cephazolin (2g IV before surgery and after 8 hours). Patients exposed to antibacterial drugs within 7 days, who had preoperative infections, or with known beta-lactam hypersensitivity were excluded. 612 patients entered the study, of whom 552 were evaluable. 276 were given cephazolin (group A) and 276 cefotaxime (group B). Groups A and B were similar for mean age, obesity, diabetes, types of diseases and obstetric history. No significant differences were observed in type of surgery (vaginal hysterectomy, abdominal hysterectomy, myomectomy and caesarean section) between 2 groups. The mean duration of surgery was 89 and 85 minutes in group A and B, respectively. 25 patients (9.1%) in group A and 20 (7.2%) in group B developed wound infections (not statistically significantly different). The percentages of patients with infections other than surgical infections were similar (i.e. 13.0 and 11.2 for the cefotaxime and the cephazolin groups, respectively). These preliminary data show that a single 2g IV dose of cefotaxime and two 2g IV doses of cephazolin have equal antimicrobial prophylactic activity in obstetric and gynaecological surgery.

RCT Entities:   Population Interventions Outcomes