The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

Stopped early · Phase 1

Conditions studied: Jaw Fractures, Infection

In brief

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

Key facts

Study ID

NCT04198129

Run by

The University of Texas Health Science Center, Houston

People needed

13

Starts

2020-10-01

Expected to finish

2022-03-20

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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
• Diabetes - Hb A1C > 10
• Immunologic compromise
• On Chemotherapy
• Interval - Injury to Surgery - > 10days
• Already receiving antibiotics for
• Another wound eg. Open fracture prophylaxis
• Documented / suspected infection
• Inability to provide informed consent.

Where it is running

• Memorial Hermann Hospital — Houston, Texas, United States
• Th University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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