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

NCT ID NCT05421741

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

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Locations

  • Atrium Health Cabarrus

    RECRUITING

    Concord, North Carolina, 28025, United States

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  • Atrium Health Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

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  • Atrium Health Navicent

    RECRUITING

    Macon, Georgia, 31201, United States

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  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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  • Carilion Clinic

    NOT_YET_RECRUITING

    Roanoke, Virginia, 24016, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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  • Florida Orthopaedic Institute

    RECRUITING

    Temple Terrace, Florida, 33637, United States

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  • Penn State Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • San Antonio Military Medical Center

    RECRUITING

    San Antonio, Texas, 78234, United States

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  • University of Florida Gainesville

    RECRUITING

    Gainesville, Florida, 32607, United States

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  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

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  • University of North Carolina Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27546, United States

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  • University of Texas Houston

    RECRUITING

    Houston, Texas, 77030, United States

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  • Valley Health System

    RECRUITING

    Winchester, Virginia, 22601, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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