The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Sultamicillin

Criteria

Inclusion Criteria:

• All mandible fracture patients planned for Open Reduction and Internal Fixation (ORIF)

Exclusion Criteria:

• Age - < 18 years

• Pregnancy

• Fracture Site - closed / non-dentate eg. Condylar neck, edentulous

• Soft Tissue Injury - > Grade 4 (GSW)

• Allergic to all study drugs

• Medical Problems

1. Diabetes - Hb A1C > 10

2. Immunologic compromise

3. On Chemotherapy

• Interval - Injury to Surgery - > 10days

• Already receiving antibiotics for

1. Another wound eg. Open fracture prophylaxis

2. Documented / suspected infection

• Inability to provide informed consent.