Clinical Trial Comparing Antibiotic Coated Nail Versus Standard Nail to Prevent Infection in Severe Open Tibia Fractures

What this Trial Is About

The trial investigates the prevention of deep infections in patients with severe open tibia fractures. It compares outcomes between those treated with a new antibiotic coated intramedullary nail and those receiving the traditional standard of care intramedullary nail. The study focuses on reducing infections that can lead to disability, rehospitalization, and in severe cases, amputation, especially among active duty military personnel. Participants are randomly assigned to one of two groups one receives an intramedullary nail coated with a mixture of vancomycin and gentamicin antibiotics, while the other receives a standard uncoated intramedullary nail. The antibiotic coating is applied using a cement mixture during the definitive fixation surgery. The trial follows patients for one year after treatment. During the 12-month follow-up, participants undergo evaluations at baseline, 6 weeks, 3 months, 6 months, and 12 months. These include patient interviews, clinical assessments, and review of medical records. Researchers measure infection rates, bone healing progress using radiographic scores, physical activity levels, return to work or duty, and various aspects of physical and mental health using standardized questionnaires. Safety and treatment outcomes are closely monitored throughout the study period.

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial