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Intramedullary Calcium Sulfate Antibiotic Depot
Sponsor: Wake Forest University Health Sciences
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.
Official title: Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
497
Start Date
2024-04-08
Completion Date
2028-01
Last Updated
2025-12-15
Healthy Volunteers
No
Interventions
Vancomycin Hydrochloride
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
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
Standard Intramedullary Nail
Locations (10)
Cedars-Sinai
Los Angeles, California, United States
Atrium Health Navicent The Medical Center
Macon, Georgia, 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
Valley Health
Winchester, Virginia, United States