Amoxycillin-clavulanic acid (Augmentin) versus metronidazole as prophylaxis in hysterectomy: a prospective, randomized clinical trial.

In order to determine the most effective regimen for the prevention of infection after elective hysterectomy, 300 patients were randomly assigned to receive three perioperative doses of either amoxycillin-clavulanic acid (1.2 g intravenous) or metronidazole (1 g suppository). Of the 280 patients who were assessable 138 were given amoxycillin-clavulanic acid and 142 received metronidazole; 268 underwent abdominal hysterectomy and 12 had vaginal hysterectomy. Patients in the amoxycillin-clavulanic acid group had significantly less infectious morbidity (13.8%) than those in the metronidazole group (33.1%). There were also statistically significant differences in favour of amoxycillin-clavulanic acid with respect to operative site infection, duration of hospital stay, need for postoperative antimicrobials, and surgery for operative site infection. But for one isolate of Bacteroides fragilis, all pathogens isolated from wound infections in the metronidazole group were aerobes. No anaerobes were isolated from patients in the amoxycillin-clavulanic acid group. The results suggest that prophylaxis for hysterectomy should consist of an agent, or combination of agents, with activity against both aerobic and anaerobic bacteria. Amoxycillin-clavulanic acid fulfils this criterion and appears to be effective and safe.

RCT Entities:   Population Interventions Outcomes