The role of postoperative prophylactic antibiotics in the treatment of facial fractures: a randomised, double-blind, placebo-controlled pilot clinical study. Part 3: Le Fort and zygomatic fractures in 94 patients

Br J Oral Maxillofac Surg. 2014 Apr;52(4):329-33. doi: 10.1016/j.bjoms.2014.01.010. Epub 2014 Mar 3.

Abstract

The aim of this study was to evaluate the difference between the effect of a 5-day and a 1-day postoperative course of antibiotics on the incidence of infection after midfacial fractures. A total of 98 patients with displaced Le Fort or zygomatic fractures that required operation were randomly assigned into 2 groups, both of which were given amoxicillin/clavulanic acid 1.2g intravenously every 8h from the time of admission until 24h postoperatively. The 5-day group was then given amoxicillin/clavulanic acid 625 mg orally 8-hourly for another 4 days. The 1-day group was given placebo orally at the same time points. Patients were followed up 1, 2, 4, 6, and 12 weeks, and 6 months, postoperatively. The development of an infection of the wound was the primary end point. Ninety-four of the 98 patients completed the study. Two of the 45 patients in the 5-day group (4%) and 2/49 in the 1-day group (4%) developed postoperative wound infections. One in each group had a purulent infection, while the others had only wound breakdown. Two patients of the 5-day group and one in the 1-day group developed rashes on the trunk. There were no significant differences in the incidence of infection or side effects between the groups. In midfacial fractures a 1-day course of antibiotics postoperatively is as effective in preventing infective complications as a 5-day regimen.

Keywords: Antibiotics; Antimicrobial agents; Infection; Le Fort; Midface fractures; Zygoma; Zygomatic fracture.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravenous
  • Administration, Oral
  • Adult
  • Amoxicillin-Potassium Clavulanate Combination / administration & dosage
  • Amoxicillin-Potassium Clavulanate Combination / therapeutic use*
  • Antibiotic Prophylaxis*
  • Double-Blind Method
  • Drug Administration Schedule
  • Exanthema / etiology
  • Facial Bones / injuries
  • Female
  • Follow-Up Studies
  • Fracture Fixation, Internal / instrumentation
  • Fracture Fixation, Internal / methods
  • Humans
  • Male
  • Maxillary Fractures / drug therapy
  • Maxillary Fractures / surgery*
  • Middle Aged
  • Orbital Fractures / drug therapy
  • Orbital Fractures / surgery
  • Pilot Projects
  • Placebos
  • Postoperative Care
  • Prospective Studies
  • Skull Fractures / drug therapy
  • Skull Fractures / surgery
  • Surgical Wound Dehiscence / etiology
  • Surgical Wound Infection / etiology
  • Treatment Outcome
  • Zygomatic Fractures / drug therapy
  • Zygomatic Fractures / surgery*

Substances

  • Placebos
  • Amoxicillin-Potassium Clavulanate Combination