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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.

Abstract
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.
AuthorsJürgen Zix, Benoit Schaller, Tateyuki Iizuka, Olivier Lieger
JournalThe British journal of oral & maxillofacial surgery (Br J Oral Maxillofac Surg) Vol. 51 Issue 4 Pg. 332-6 (Jun 2013) ISSN: 1532-1940 [Electronic] Scotland
PMID22981342 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2012 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Chemical References
  • Biocompatible Materials
  • Ethisorb
  • Placebos
  • Polyesters
  • Polyglycolic Acid
  • poly(lactide)
  • Amoxicillin-Potassium Clavulanate Combination
  • Titanium
Topics
  • Absorbable Implants
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin-Potassium Clavulanate Combination (administration & dosage, therapeutic use)
  • Antibiotic Prophylaxis
  • Biocompatible Materials (chemistry)
  • Double-Blind Method
  • Facial Bones (injuries)
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Orbital Fractures (drug therapy, surgery)
  • Pilot Projects
  • Placebos
  • Polyesters (chemistry)
  • Polyglycolic Acid (chemistry)
  • Prospective Studies
  • Plastic Surgery Procedures (instrumentation, methods)
  • Skull Fractures (drug therapy)
  • Surgical Mesh
  • Surgical Wound Infection (prevention & control)
  • Titanium (chemistry)
  • Treatment Outcome
  • Young Adult

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