drugset
drugset / Trial / NCT03483363

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

NCT03483363 ↗

Phase 4 Terminated 39 enrolled The University of Texas Health Science Center, Houston
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2018-10-09
Primary completion
2022-01-02
Completion
2022-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Gentamicin Small molecule 80 mg Topical

Indications

No indication recorded.