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Can a second antibiotic powder slash infection risk in severe fractures?

NCT ID NCT04597008

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study tested whether adding tobramycin powder to the standard vancomycin powder in the wound during surgery reduces infections after high-risk leg fracture repair. About 1,550 adults with tibial plateau or pilon fractures at high infection risk took part. The main goal was to see if the combination lowered deep infections needing surgery within 6 months.

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 powders
What this could lead to
If successful, this could lead to a simple, low-cost way to reduce serious infections after high-risk fracture surgery, lowering the need for additional operations.
What could go wrong
This is a completed Phase 3 trial, but the benefit of adding tobramycin may be small or not outweigh risks like antibiotic resistance or side effects. Results may not apply to all fracture types.

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

1,660 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 2025

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 80 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: * Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection: 1. Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved. 2. Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment. 3. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds. * Patients ages 18 through 80 years. Exclusion Criteria: * Study injury is already infected at time of study enrollment. * Definitive fixation of the study injury prior to enrollment in the study. * The patient never receives study fixation. * Massive myonecrosis from ipsilateral leg compartment syndrome. * Currently pregnant. * Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information). * Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome). * Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.

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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

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246, United States

  • Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute

    Charlotte, North Carolina, 28203, United States

  • Cedars Sinai

    West Hollywood, California, 90069, United States

  • Core Well Health

    Grand Rapids, Michigan, 49503, United States

  • Dartmouth Hitchcock

    Lebanon, New Hampshire, 03766, United States

  • Harvard/Mass General/Brigham Hospitals

    Boston, Massachusetts, 02115, United States

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415, United States

  • Indiana University School of Medicine - Methodist Hospital

    Indianapolis, Indiana, 46202, United States

  • Indiana University/Eskenazi Health

    Indianapolis, Indiana, 46202, United States

  • Inova Fairfax MEdical Campus

    Falls Church, Virginia, 22042, United States

  • Jamaica Hospital Medical Center

    Queens, New York, 11418, United States

  • Keck School of Medicine of USC

    Los Angeles, California, 90033, United States

  • LSU Health Sciences

    New Orleans, Louisiana, 70112, United States

  • Loyola University Chicago

    Chicago, Illinois, 60153, United States

  • METROHealth

    Cleveland, Ohio, 44109, United States

  • Medical University of South Carolina -

    Charleston, South Carolina, 29425, United States

  • New York Presbyterian/Hospital for Special Surgery

    New York, New York, 10021, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201, United States

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033, United States

  • Rhode Island Hospital/Brown University

    Providence, Rhode Island, 02905, United States

  • St Mary's University/Tenent Health

    West Palm Beach, Florida, 33407, United States

  • Stanford University

    Redwood City, California, 94063, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • UTHealth/McGovern Medical School

    Houston, Texas, 77030, United States

  • University of Alabama Heersink School of Medicine

    Birmingham, Alabama, 35205, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Maryland Shock Trauma Center

    Baltimore, Maryland, 21201, United States

  • University of Maryland Shock Trauma/Capitol Regions

    Baltimore, Maryland, 21201, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19106, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin

    Madison, Wisconsin, 53705, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298, United States

  • _University of California, San Francisco

    San Francisco, California, 94110, United States

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