RANDOMIZED CONTROLLED TRIAL OF SINGLE-DOSE ANTIBIOTIC-PROPHYLAXIS IN SURGICAL-TREATMENT OF CLOSED FRACTURES - THE DUTCH-TRAUMA-TRIAL

Background The efficacy of prophylactic antibiotics in fracture surger y remains controversial for lack of well-documented prospective studie s. We report here the findings of the Dutch Trauma Trial, a prospectiv e, randomised, double-blind, placebo-controlled study of antibiotic pr ophylaxis in the primary operative treatment of limb fractures. Ceftri axone was chosen because of its broad spectrum of activity and because its pharmacokinetic profile, including high serum levels, high tissue penetration, and long elimination half-life, makes it suitable for si ngle-dose prophylaxis. Methods Patients aged 18 years or more, attendi ng one of fourteen Dutch centres for acute treatment of closed fractur es, were randomly allocated to a single preoperative dose of ceftriaxo ne 2 g or placebo, and evaluated for development of wound infection an d nosocomial infection at 10 days, 30 days, and 120 days, To assess th e effects of drop-outs and withdrawals, best-case and worst-case analy ses were performed. Findings A total of 2195 patients were included, T he incidence of superficial and deep wound infections after placebo wa s 8.3%, compared with 3.6% in the ceftriaxone group (p<0.001, Pearson chi(2)-test), The rate of nosocomial infection in the first month was 10.2% with placebo and 2.3% with ceftriaxone (p<0.001, Pearson chi(2)- test). Gram-positive bacteria were found in 74.5% of wound infections and 13.4% of nosocomial infections. Interpretation Adequate single-dos e prophylaxis with a long-acting broad-spectrum antibiotic substantial ly reduces the incidence of wound infection and early nosocomial infec tion after surgery for closed fractures.