NCT03483363

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline)	Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.
DRUG	topical irrigation with sterile normal saline (NS)	Fractures will be irrigated with sterile normal saline prior to closure.
DRUG	intravenous (IV) prophylactic antibiotic	All arms with receive standard parenteral (IV) prophylactic antibiotic.

Timeline

• Start date: 2018-10-09
• Primary completion: 2022-01-02
• Completion: 2022-01-02
• First posted: 2018-03-30
• Last updated: 2024-05-08
• Results posted: 2024-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study