Intramedullary Calcium Sulfate Antibiotic Depot
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.
| Condition(s) | Open tÃbia Fracture, Osteomyelitis Tibia, Tibial Fractures |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care. |
| Who can participate | Inclusion Criteria: * Patients 18 years and older * Type II or III open tibia fracture requiring definitive fixation with intramedullary nail Exclusion Criteria: * Less than 18 years of age * Allergy to vancomycin or tobramycin * Hypercalcemia * Unable to speak English or Spanish * No email, phone, or other point of contact * Pregnant and lactating women * Prisoner |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Wake Forest University Health Sciences |
| Locations | Los Angeles, California, United States; Macon, Georgia, United States; Lexington, Kentucky, United States; New Orleans, Louisiana, United States; Charlotte, North Carolina, United States; Concord, North Carolina, United States (+4 more sites) |
| Start date | 2024-04-08 |
| NCT ID | NCT05766670 |
| Official listing | https://clinicaltrials.gov/study/NCT05766670 |