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).
Meijer
W S
WS
Department of Surgery, Sint Clara Hospital, Rotterdam, The Netherlands.
Schmitz
P I
PI
D000368:Aged; D000369:Aged, 80 and over; D001646:Bile / Q000382:microbiology; D001662:Biliary Tract Surgical Procedures; D002444:Cefuroxime / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality; D011292:Premedication; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000382:microbiology / Q000517:prevention & control*
D002444:Cefuroxime