Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Recruiting now · Phase 4

Conditions studied: Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture

In brief

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 facts

Study ID

NCT05421741

Run by

Wake Forest University Health Sciences

People needed

484

Starts

2023-05-15

Expected to finish

2027-12-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years or older
• Gustilo 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 gentamicin
• Unable to speak English or Spanish
• Pregnant and lactating women
• Prisoner
• Unable to follow up for 12 months

Where it is running

• Valley Health System — Winchester, Virginia, United States (enrolling)
• Florida Orthopaedic Institute — Temple Terrace, Florida, United States (enrolling)
• Atrium Health Navicent — Macon, Georgia, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, 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 — Winston-Salem, North Carolina, United States (enrolling)
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• University of Texas Houston — Houston, Texas, United States (enrolling)
• San Antonio Military Medical Center — San Antonio, Texas, United States (enrolling)
• University of Florida Gainesville — Gainesville, Florida, United States (enrolling)
• Carilion Clinic — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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