The role of postoperative prophylactic antibiotics in the treatment of facial fractures: a randomised, double-blind, placebo-controlled pilot clinical study. Part 1: orbital fractures in 62 patients.

The aim of this study was to evaluate the difference between the effects of a 5-day and a 1-day course of antibiotics on the incidence of postoperative infection after displaced fractures of the orbit. A total of 62 patients with orbital blow-out fractures were randomly assigned to two groups, both of which were given amoxicillin/clavulanic acid 1.2g intravenously every 8h from the time of admission to 24h postoperatively. The 5-day group were then given amoxicillin/clavulanic acid 625 mg orally every 8h for 4 further days. The 1-day group were given placebo orally at the same time intervals. Follow up appointments were 1, 2, 4, 6, and 12 weeks, and 6 months, postoperatively. An infection in the orbital region was the primary end point. Sixty of the 62 patients completed the study. Two of the 29 patients in the 5-day group (6.8%) and 1/31 patients in the 1-day group (3.2%) developed local infections. In the 5-day group 1 patient developed diarrhoea. In the 1-day group 1 patient developed a rash on the trunk. There were no significant differences in the incidence of infection or side effects between the groups. We conclude that in displaced orbital fractures a postoperative 1-day course of antibiotics is as effective in preventing infective complications as a 5-day regimen.

RCT Entities:   Population Interventions Outcomes