Topical Antibiotic Irrigation (Bacitracin) in Prophylaxis of Midfacial Fracture Surgical Wounds New Title Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds

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

Summary

The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).

In April of 2020 a petition was made to add gentamycin and remove bacitracin after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted has removed bacitracin from its formulary.

The modification was approved.

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

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Bacitracin

Criteria

Inclusion Criteria:

• patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care

• patients who are admitted to Memorial Hermann hospital at Texas Medical Center

• able to sign their own consent

Exclusion Criteria:

• infected surgical sites

• allergies to bacitracin