Randomised controlled trial of single-dose antibiotic prophylaxis in surgical treatment of closed fractures: the Dutch Trauma Trial

doi:10.1016/S0140-6736(96)90606-6

The Lancet

Volume 347, Issue 9009, 27 April 1996, Pages 1133-1137

https://doi.org/10.1016/S0140-6736(96)90606-6 Get rights and content

Abstract

Summary

Background The efficacy of prophylactic antibiotics in fracture surgery remains controversial for lack of well-documented prospective studies. We report here the findings of the Dutch Trauma Trial, a prospective, randomised, double-blind, placebo-controlled study of antibiotic prophylaxis in the primary operative treatment of limb fractures. Ceftriaxone 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 single-dose prophylaxis.

Methods Patients aged 18 years or more, attending one of fourteen Dutch centres for acute treatment of closed fractures, were randomly allocated to a single preoperative dose of ceftriaxone 2 g or placebo, and evaluated for development of wound infection and nosocomial infection at 10 days, 30 days, and 120 days. To assess the effects of drop-outs and withdrawals, best-case and worst-case analyses were performed.

Findings A total of 2195 patients were included. The incidence of superficial and deep wound infections after placebo was 8·3%, compared with 3·6% in the ceftriaxone group (p<0·001, Pearson X²-test). The rate of nosocomial infection in the first month was 10·2% with placebo and 2·3% with ceftriaxone (p<0·001, Pearson χ2-test). Gram-positive bacteria were found in 74·5% of wound infections and 13·4% of nosocomial infections.

Interpretation Adequate single-dose prophylaxis with a long-acting broad-spectrum antibiotic substantially reduces the incidence of wound infection and early nosocomial infection after surgery for closed fractures.

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^☆: *Other participants in the Dutch Trauma Trial are listed at the end of the article

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ArticlesRandomised controlled trial of single-dose antibiotic prophylaxis in surgical treatment of closed fractures: the Dutch Trauma Trial☆

Abstract

Lancet

Injury

Am J Surg

Surg Clin N Am

Surg Clin N Am

Postoperative wound infection

Ann Surg

Antibiotika-Prophylaxe in der Traumatologie

Hefte Unfallheilkd

Antibiotic prophylaxis with two doses of cephalosporin in patients managed with internal fixation for a fracture of the hip

J Bone Joint Surg

A double-blind clinical trial of prophylactic antibiotics in hip fractures

J Bone Joint Surg

Perioperative cefazolin prophylaxis in hip fracture surgery

Can J Surg

Prophylactic antibiotics in hip fractures: a double-blind prospective study

J Bone Joint Surg

Cloxacillin in the prophylaxis of postoperative infections of the hip

J Bone Joint Surg

Prophylactic cefamandole in orthopaedic surgery

J Bone Joint Surg

Prophylaxis with cefamandole nafate in elective orthopedic surgery

Clin Orthop

Articles
Randomised controlled trial of single-dose antibiotic prophylaxis in surgical treatment of closed fractures: the Dutch Trauma Trial☆