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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Sponsor: Wake Forest University Health Sciences
Summary
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
484
Start Date
2023-05-15
Completion Date
2027-12
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
Antibiotic coated intramedullary Nail
Antibiotic coated intramedullary nail: A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.
Standard Intramedullary Nail
Standard Intramedullary Nail
Locations (14)
University of Florida Gainesville
Gainesville, Florida, United States
Florida Orthopaedic Institute
Temple Terrace, Florida, United States
Atrium Health Navicent
Macon, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 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
Winston-Salem, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Houston
Houston, Texas, United States
San Antonio Military Medical Center
San Antonio, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Valley Health System
Winchester, Virginia, United States