Intramedullary Calcium Sulfate Antibiotic Depot
Recruiting now · Phase 3
Conditions studied: Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures
In brief
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.
Key facts
- Study ID
- NCT05766670
- Run by
- Wake Forest University Health Sciences
- People needed
- 497
- Starts
- 2024-04-08
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 18 years and older
- Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
You may not qualify if…
- 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
Where it is running
- Valley Health — Winchester, Virginia, United States (enrolling)
- Atrium Health Navicent The Medical Center — Macon, Georgia, United States (enrolling)
- Cedars-Sinai — Los Angeles, California, United States (enrolling)
- Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States (enrolling)
- Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
- Atrium Health Cabarrus — Concord, North Carolina, United States (enrolling)
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)
- Pennsylvania State University — Hershey, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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