New Antibiotic Treatment Strategy Versus Standard Care for Severe Open Fractures Including Tibia and Hindfoot Injuries

What this Trial Is About

Researchers are evaluating two different antibiotic strategies to prevent infections and complications in patients with severe open fractures of the tibia and hindfoot, including Gustilo type IIIB and selected IIIA fractures, as well as trauma-related transtibial amputations in the injured area. This Phase 3 study compares the current standard of care to a new antibiotic protocol called SEXTANT, aiming to reduce fracture-related infections and antibiotic resistance. The study is conducted at established level 1 trauma centers and follows recognized trauma care guidelines. Participants will be randomly assigned to one of two groups the standard care group receives usual prophylactic antibiotic treatment according to their surgeons practice, which may include topical antibiotics. The experimental SEXTANT group receives a combination of topical Vancomycin and Tobramycin powders applied directly to the wound and hardware at the time of final wound closure, along with 72 hours of targeted systemic antibiotics to cover both gram-positive and gram-negative bacteria. Until definitive wound closure, all patients receive usual care and systemic antibiotics as soon after injury as possible. During the study, patients will be monitored for infection outcomes, including fracture-related infections within 180 days and one year after wound closure. Researchers will also assess antibiotic-related complications, serious adverse events, and the development of resistant bacteria. Wound samples will be collected at closure for microbiology, and a subset of patients will undergo advanced genetic testing for pathogens. Follow-up care and treatments will continue as usual under the surgeons guidance, with study assessments integrated into routine visits over the study period.

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2