Intramedullary Calcium Sulfate Antibiotic Depot

This study tests whether packing an antibiotic-containing calcium sulfate material into the bone canal (intramedullary space) at the time of surgical fracture repair reduces infection rates in patients with serious open tibia (shinbone) fractures. Open fractures — where the bone breaks through the skin — carry a high risk of infection because bacteria from the environment contaminate the wound at the time of injury. Traditional treatment involves systemic antibiotics, but local antibiotic delivery at the fracture site may provide superior protection. Adults 18 and older with a Type II or III open tibia fracture (significant soft tissue injury with exposed bone) requiring intramedullary nail fixation surgery are eligible. Patients with allergies to the antibiotics used (vancomycin or tobramycin), high calcium levels, those who speak neither English nor Spanish, pregnant or breastfeeding women, and prisoners are excluded. Infection after open fracture fixation is one of the most feared surgical complications — it can lead to bone infection (osteomyelitis), multiple surgeries, prolonged disability, and in severe cases, amputation. Local antibiotic depots could revolutionize fracture care for high-risk wounds, providing targeted, sustained antibiotic coverage right where it is needed most. This study could establish a new standard of care for a common and serious injury.