Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT

Phase 3 Recruiting 1200 enrolled Major Extremity Trauma Research Consortium United States Department of Defense · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

Timeline

Start: 2021-05-07
Primary completion: 2026-09-30
Completion: 2027-03-31

Drugs

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

Indications

No indication recorded.