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RECRUITING Phase 3 ClinicalTrials.gov

Intramedullary Calcium Sulfate Antibiotic Depot

Sponsor: Wake Forest University Health Sciences • ClinicalTrials.gov ID: NCT05766670

Registry updated: 2026-10-14
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Description

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.

Interventions

  • Vancomycin Hydrochloride (Drug)
    The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.
  • Gentamicin (Drug)
    The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.
  • Standard Intramedullary Nail (Other)
    Standard Intramedullary Nail

Eligibility criteria

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

Conditions

Open tíbia Fracture Osteomyelitis Tibia Tibial Fractures

Locations

  • Cedars-Sinai — Los Angeles, California, United States
  • Atrium Health Navicent The Medical Center — Macon, Georgia, United States
  • University of Chicago — Chicago, Illinois, United States
  • University of Kentucky — Lexington, Kentucky, United States
  • Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
  • Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States
  • Atrium Health Cabarrus — Concord, North Carolina, United States
  • Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
  • Pennsylvania State University — Hershey, Pennsylvania, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Carilion Clinic — Roanoke, Virginia, United States
  • Valley Health — Winchester, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record