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Could a bone cement antibiotic stop infections after open leg fractures?

NCT ID NCT05766670

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests whether placing an antibiotic depot directly into the bone during surgery can prevent infections in people with severe open tibia fractures. About 497 adults with type II or III open fractures will be randomly assigned to get either the antibiotic depot plus standard care or standard care alone. The main goal is to see if the depot reduces deep surgical site infections within 12 months.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 497 people

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

Started

Apr 2024

Expected to finish

Jan 2028

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 and older * 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 tobramycin * Hypercalcemia * Unable to speak English or Spanish * No email, phone, or other point of contact * Pregnant and lactating women * Prisoner

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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 tíbia 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

    10 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, 28204, United States

  • Atrium Health Navicent The Medical Center

    RECRUITING

    Macon, Georgia, 31201, United States

  • Atrium Health Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Cedars-Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • Louisiana State University Health Sciences Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Pennsylvania State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • University of Kentucky

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40508, United States

  • Valley Health

    RECRUITING

    Winchester, Virginia, 22601, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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