Prophylactic use of cefuroxime in biliary tract surgery: randomized controlled trial of single versus multiple dose in high-risk patients. Galant Trial Study Group.

To assess the efficacy of a single-dose short-acting antibiotic in the prevention of septic complications after biliary surgery, a randomized controlled double-blind multicentre trial was conducted. One dose of cefuroxime before operation (1.5 g intravenously) was compared with a three-dose regimen of the drug as control (1.5 g before and two doses of 0.75 g after operation). The study group comprised 1004 patients with risk factors for infection, who were followed for 4-6 weeks after surgery. The characteristics of both treatment groups were comparable. No significant difference was found between the one- and three-dose antibiotic regimens in preventing postoperative wound infection: 6.6 versus 6.2 per cent for minor wound infection (P = 0.78) and 4.6 versus 3.8 per cent for major wound infection (P = 0.52). The estimated difference in major wound infection rate between the two groups was 0.8 per cent (95 per cent confidence interval -1.7 to 3.3 per cent).