title: The role of postoperative prophylactic antibiotics in the treatment of facial fractures: a randomized, double-blind, placebo-controlled pilot clinical study. Part 2: Mandibular fractures in 59 patients.
abstract: The aim of this study was to evaluate the difference between a 5-day and a 1-day postoperative course of antibiotic on the incidence of infection after mandibular fractures involving the alveolus. Sixty-two patients with fractures of the mandible involving the dentoalveolar region were randomly assigned to 2 groups, both of which were given amoxicillin/clavulanic acid 1.2 g intravenously every 8 h from admission until 24 h postoperatively. The 5-day group were then given amoxicillin/clavulanic acid 625 mg orally every 8 h for another 4 days. The 1-day group was given an oral placebo at the same intervals. Follow-up appointments were 1, 2, 4, 6, 12 weeks and 6 months postoperatively. Development of an infection was the primary end point. Fifty-nine of the 62 patients completed this study. Six of the 30 patients in the 5-day group (20%) and 6 out of the 29 in the 1-day group (21%) developed local wound infections. Three of the 6 in the 1-day group developed purulent discharge and swelling. One patient in the 5-day group developed a rash on the trunk. There were no significant differences in the incidence of infection or side effects between the groups. In fractures of the mandible involving the alveolus, a 1-day postoperative course of antibiotic 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: Benoit
authors.initials: B
authors.lastname: Schaller
authors.forename: Poh Luon
authors.initials: PL
authors.lastname: Soong
authors.forename: Jürgen
authors.initials: J
authors.lastname: Zix
authors.forename: Tateyuki
authors.initials: T
authors.lastname: Iizuka
authors.forename: Olivier
authors.initials: O
authors.lastname: Lieger
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000539:Alveolar Process / Q000293:injuries / Q000601:surgery; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D019072:Antibiotic Prophylaxis; D004311:Double-Blind Method; D004322:Drainage / Q000379:methods; D005076:Exanthema / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D005593:Fracture Fixation, Internal / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008297:Male; D008337:Mandibular Fractures / Q000188:drug therapy / Q000601:surgery*; D008875:Middle Aged; D010865:Pilot Projects; D010919:Placebos; D011182:Postoperative Care; D011206:Povidone-Iodine / Q000627:therapeutic use; D011446:Prospective Studies; D013529:Surgical Wound Dehiscence / Q000209:etiology; D013530:Surgical Wound Infection / Q000209:etiology; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D010919:Placebos; D019980:Amoxicillin-Potassium Clavulanate Combination; D011206:Povidone-Iodine
keywords: Adverse drug event; Antibiotic; Antimicrobial agents; Infection; Mandible fractures