Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures

Summary

Facial fractures make up a significant proportion of injuries in trauma patients. Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today. Chole and his team could show that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42,2% to 8.9%. However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration of 7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance. In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of an postoperative infection. Up to date there is no standard to support the administration of antibiotics after surgical repair of a facial fracture.

The purpose of this prospective, randomized double-blinded trial is to investigate the utility of antibiotics administered in the postoperative period after surgical revision of facial fractures.

Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally effective as a long-term administration of 5 days in facial fractures.

Conditions

• Surgical Wound Infection

Interventions

DRUG

Amoxicillin/clavulanic acid

Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 1 then receives amoxicillin/clavulanic acid 625 mg orally every eight hours for four days.

DRUG

Amoxicillin plus placebo

Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 2 receives oral placebo using the same schedule for the same duration as group 1.

Sponsors & Collaborators

• Schweizerische Unfallversicherung SUVA, Switzerland

  collaborator UNKNOWN

• Mepha Parma AG, Switzerland

  collaborator UNKNOWN

• GlaxoSmithKline AG, Switzerland

  collaborator UNKNOWN

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Olivier Lieger, MD, DMD · Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland

• Tateyuki Iizuka, MD, DDS, PhD · Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2012-11-30

Completion

2012-12-31

Countries

• Switzerland

Study Locations