Infectious complications after 809 biliary tract operations and results of a prospective randomized single-blind study comparing cefoxitin versus ampicillin plus an inhibitor of beta-lactamases.

A retrospective analysis of 809 biliary tract operations revealed postoperative wound infections in 13.4% of 278 patients with bactericholia, compared to 6.9% in patients without bactericholia. More than one third of isolated bacteria were resistant to ampicillin. This was the basis to conduct a prospective randomized single-blind study to compare the efficacy of ampicillin in combination with the beta-lactamase-inhibitor sulbactam with cefoxitin as perioperative prophylaxis in elective biliary surgery. Patients received a single dose of either 2 g ampicillin plus 1 g sulbactam or 2 g cefoxitin as intravenous short-infusion approximately 30 min prior to skin incision. Both groups were comparable concerning demographic and nosographic data. 80 of 83 patients were evaluable for efficacy; 39 received ampicillin/sulbactam and 41 cefoxitin. In the cefoxitin group two wound infections were observed. In the ampicillin/sulbactam group one patient developed postoperative temperatures of greater than 39.0 degrees C, which was regarded as a wound-related infectious complication. In addition, there occurred five urinary tract infections (cefoxitin: 3; ampicillin/sulbactam: 2) but no pulmonary infection. In conclusion, no significant difference between the two groups could be shown. Both regimens were well tolerated with no significant differences between treatment groups. The combination of ampicillin with the beta-lactamase-inhibitor sulbactam can be regarded as safe and as effective compared to cefoxitin for single-dose prophylaxis of post-operative infections after biliary tract operations.

RCT Entities:   Population Interventions Outcomes