Comparing Antibiotic Calcium Sulfate Depot Versus Standard Nail Treatment for Preventing Infection in Open Tibia Fractures

What this Trial Is About

Researchers are investigating the best treatment to prevent infections in patients with severe open lower leg fractures, specifically open tibia fractures classified as Type II or III. This randomized clinical trial compares the use of a calcium sulfate antibiotic depot placed inside the bone at the time of final fracture fixation versus the standard treatment with an intramedullary nail alone. The study aims to reduce the frequency of fracture-related infections and improve recovery outcomes in this patient group. Participants will be randomly assigned to one of two groups one group will receive an intramedullary calcium sulfate antibiotic depot mixed with vancomycin and tobramycin powders during their final fracture fixation surgery, while the other group will undergo the standard intramedullary nailing procedure without the antibiotic depot. Both groups will also receive standard wound care and systemic antibiotics around the time of surgery. Throughout the 12-month study period, participants will be followed with interviews and clinical data collection at baseline, 6 weeks, 3 months, 6 months, and 12 months. Researchers will monitor for deep surgical site infections as the primary outcome. Secondary measurements include return to surgery, bone healing progress assessed by imaging, wound drainage, time to return to work or duty, physical activity levels, and various health and quality of life questionnaires. This comprehensive follow-up helps assess both safety and recovery after treatment.

Intramedullary Calcium Sulfate Antibiotic Depot