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New antibiotic cocktail aims to slash infection risk in severe bone breaks

NCT ID NCT04678154

Disease control Sponsor: Major Extremity Trauma Research Consortium 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 23, 2026 · Updated 2 times

Summary

This study tests whether a new antibiotic protocol can prevent infections in people with severe open fractures (where the bone breaks through the skin). The experimental group gets antibiotics applied directly to the wound before closure, plus extended systemic antibiotics. The control group gets standard care. The goal is to see if the new approach lowers infection rates. The trial is currently recruiting 1,200 participants.

What this could mean

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

Active substance
Vancomycin and Tobramycin applied directly to the wound before closure, plus at least 72 hours of systemic antibiotics
What this could lead to
If successful, this could reduce the risk of serious infections after severe open fractures, potentially improving recovery and reducing the need for additional surgeries.
What could go wrong
This is still a research study, and the new antibiotic protocol may not prove more effective than current standard care. There are also risks of antibiotic side effects or allergic reactions.

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 600 people

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

Started

May 2021

Expected to finish

Mar 2029

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 to 64 years

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: 1. Injury meeting at least one of the following criteria: a. Gustilo type III fractures of the tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon); ankle (OTA 44); calcaneus (OTA 82) and/or talus (OTA 81) with injury characteristics meeting at least one of the following criteria: i. All IIIB fractures ii. IIIA fractures that require a planned second debridement prior to definitive closure / coverage iii. IIIA fractures with extensive contamination or muscle damage precluding definitive internal fixation at the time of initial surgery iv. IIIA fractures with extensive degloving or wound greater than 10 cm after debridement (if indicated, primary wound closure is allowed. Primary wound closure refers to the definitive closure of the wound at the initial surgical event, without plans for re-entry for additional debridement and/or fracture fixation) v. IIIA fractures severe fracture comminution resulting from high energy trauma (if indicated, primary wound closure/coverage is allowed) vi. IIIA fractures with AO/OTA OFC contamination level of severe with material imbedded into bone or soft tissue or with a severe high risk environmental contamination from farm, fecal, dirty water inoculation or other equivalent (if indicated, primary wound closure/coverage is allowed) vii. IIIA Fractures where the skin could be closed after extensive muscle or bone removal (if indicated, primary wound closure/coverage is allowed) viii. IIIA fractures with bone loss resulting in a circumferential gap of 1 cm after debridement (if indicated, primary wound closure/coverage is allowed) ix. Fractures where fasciotomies were performed for impending or diagnosed compartment syndromes (regardless of the initial open or closed classification of the fracture x. Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage 2. Ages 18 - 64 years inclusive 3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections. 4. Patients may have a traumatic brain injury. 5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur, or foot injuries. 6. Patients may be treated initially at an outside institution prior to transferring to the study institution, as long as the definitive wound closure/coverage was not performed prior to entrance into the study. 7. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study. 8. Patients may have co-existing non-tibial or hindfoot infections, with or without antibiotic treatment. 9. Patients may be definitively stabilized using any method (nail, plate, ex fix, or cast). 10. Patients may have fasciotomy. Exclusion Criteria: 1. Patient speaks neither English or Spanish 2. Patient in current therapy for a wound, implant or fracture site infection related to the study site. 3. Patient is pregnant, potentially pregnant, or lactating. 4. Patient likely to have difficulty maintaining follow-up, including: 1. Diagnosis of a severe psychiatric condition 2. Intellectually challenged without adequate family support 3. Resides outside of the hospital's catchment area, unless willing to follow-up by phone or telemedicine 4. Planning to follow-up at another medical center, unless willing to follow-up by phone or telemedicine 5. Being a prisoner 6. Not having a means of contact (address, cell phone, home phone, e-mail)

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

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

Post operative surgical site infection

How to take part

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

  1. The places running it

    31 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 Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Brown University/Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • Dartmouth Hitchcock

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Harvard/Mass General/Brigham Hospitals

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Hennepin County Medical Center / Minneapolis

    RECRUITING

    Minneapolis, Minnesota, 55415, United States

  • Indiana University School of Medicine - Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Indiana University/Eskenazi Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Inova Fairfax MEdical Campus

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Jamaica Hospital Medical Center

    RECRUITING

    Jamaica, New York, 11418, United States

  • LSU Health Sciences

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • METROHealth

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43201, United States

  • Rhode Island Hospital/Brown University

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • St Mary's University/Tenent Health

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

  • Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • University of California at San Francisco

    RECRUITING

    San Francisco, California, 94110, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

  • University of Maryland , MD Department of Orthopaedics

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Oklahoma College of Medicine

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas Health Science Center - Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University Medical Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Walter Reed Military Medical Center

    RECRUITING

    Bethesda, Maryland, 20889, United States

  • _University of California, San Francisco

    RECRUITING

    San Francisco, California, 94110, United States

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