Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

Phase 3 Completed 1550 enrolled Major Extremity Trauma Research Consortium United States Department of Defense · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

Timeline

Start: 2021-05-11
Primary completion: 2025-07-30
Completion: 2025-07-30

Publications

Schrank GM, O'Hara NN, Lee S, Degani Y, Chung S, Carlini AR, Castillo RC, O'Toole RV. Safety of topical tobramycin powder during operative treatment of fractures. J Antimicrob Chemother. 2025 Sep 3;80(9):2417-2420. doi: 10.1093/jac/dkaf230.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tobramycin	Small molecule	1200 mg	Topical
Comparator	Vancomycin	Other / unclassified	1000 mg	Topical

Indications

No indication recorded.