Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: GlaxoSmithKline AG, Switzerland; Mepha Parma AG, Switzerland; Schweizerische Unfallversicherung SUVA, Switzerland
• Treatments: Amoxicillin; Anti-Bacterial Agents; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• Isolated orbital fracture, zygomatic fracture, mandibular fracture, or LeFort I/II/III fracture which requires surgical treatment

• Written informed consent obtained

Exclusion Criteria

• Need of intensive care treatment

• Presence of an acute bacterial infection

• Gunshot wounds

• Pathological fracture

• Skull base fracture with rhinoliquorrhea or intracranial emphysema

• History of malignancy or radiation to the head and neck area

• Known hypersensitivity, allergy to penicillin or other beta-lactam antibiotics

• Reduced body weight (<40kg or BMI<17), severe renal insufficiency (stage 4 according to the Kidney Disease Outcomes Quality Initiative (KDOQI))

• Insufficient patient compliance