title: 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.
authors.affiliation: Department of Cranio-Maxillofacial Surgery, Inselspital, Bern University Hospital, and University of Bern, Switzerland.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Zix
authors.forename: Benoit
authors.initials: B
authors.lastname: Schaller
authors.forename: Tateyuki
authors.initials: T
authors.lastname: Iizuka
authors.forename: Olivier
authors.initials: O
authors.lastname: Lieger
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D001672:Biocompatible Materials / Q000737:chemistry; D004311:Double-Blind Method; D005147:Facial Bones / Q000293:injuries; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009917:Orbital Fractures / Q000188:drug therapy / Q000601:surgery*; D010865:Pilot Projects; D010919:Placebos; D011091:Polyesters / Q000737:chemistry; D011100:Polyglycolic Acid / Q000737:chemistry; D011446:Prospective Studies; D019651:Plastic Surgery Procedures / Q000295:instrumentation / Q000379:methods; D012887:Skull Fractures / Q000188:drug therapy; D013526:Surgical Mesh; D013530:Surgical Wound Infection / Q000517:prevention & control; D014025:Titanium / Q000737:chemistry; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001672:Biocompatible Materials; C460779:Ethisorb; D010919:Placebos; D011091:Polyesters; D011100:Polyglycolic Acid; C033616:poly(lactide); D019980:Amoxicillin-Potassium Clavulanate Combination; D014025:Titanium