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

NCT ID NCT05421741

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 242 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients 18 years or older * Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail Exclusion Criteria: * 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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

  • The University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, 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

More trials for these conditions

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