Status:
RECRUITING
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Osteomyelitis Tibia
Tibial Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 intra...
Detailed Description
Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty milita...
Eligibility Criteria
Inclusion
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Exclusion
- Less than 18 years of age
- Allergy to vancomycin or gentamicin
- Unable to speak English or Spanish
- Pregnant and lactating women
- Prisoner
- Unable to follow up for 12 months
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT05421741
Start Date
May 15 2023
End Date
December 1 2027
Last Update
December 15 2025
Active Locations (14)
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1
University of Florida Gainesville
Gainesville, Florida, United States, 32607
2
Florida Orthopaedic Institute
Temple Terrace, Florida, United States, 33637
3
Atrium Health Navicent
Macon, Georgia, United States, 31201
4
University of Kentucky
Lexington, Kentucky, United States, 40536