New Antibiotic-Coated nail aims to stop bone infections after severe leg breaks

NCT ID NCT05421741

Recruiting now Prevention Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether coating a metal rod (intramedullary nail) with antibiotics (vancomycin and gentamicin) can prevent deep infections in people with severe open tibia fractures. About 484 adults with Gustilo Type II or III open tibia fractures will be randomly assigned to receive either the antibiotic-coated nail or a standard nail. The main goal is to see how many develop a deep surgical site infection within 12 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: antibiotic-coated intramedullary nail (vancomycin and gentamicin mixed with bone cement)
What this could lead to: If it works, this could provide a simple way to prevent serious bone infections after open tibia fractures, reducing the need for additional surgeries and antibiotics.
What could go wrong: This is a single trial with 484 participants, and the antibiotic coating may not reduce infections significantly. There is also a risk of allergic reactions or antibiotic resistance.

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Conditions

The condition(s) this trial relates to.

osteomyelitis tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OPEN TIBIA FRACTURE OSTEOMYELITIS TIBIA TIBIAL FRACTURES

Contacts and locations

Locations

Atrium Health Cabarrus
RECRUITING

Concord, North Carolina, 28025, United States
Atrium Health Carolinas Medical Center
RECRUITING

Charlotte, North Carolina, 28203, United States
Atrium Health Navicent
RECRUITING

Macon, Georgia, 31201, United States
Atrium Health Wake Forest Baptist
RECRUITING

Winston-Salem, North Carolina, 27157, United States
Carilion Clinic
NOT_YET_RECRUITING

Roanoke, Virginia, 24016, United States
Florida Orthopaedic Institute
RECRUITING

Temple Terrace, Florida, 33637, United States
Penn State Milton S. Hershey Medical Center
RECRUITING

Hershey, Pennsylvania, 17033, United States
San Antonio Military Medical Center
RECRUITING

San Antonio, Texas, 78234, United States
University of Florida Gainesville
RECRUITING

Gainesville, Florida, 32607, United States
University of Kentucky
RECRUITING

Lexington, Kentucky, 40536, United States
University of North Carolina Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27546, United States
University of Texas Houston
RECRUITING

Houston, Texas, 77030, United States
Valley Health System
RECRUITING

Winchester, Virginia, 22601, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States

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