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Can a second antibiotic powder slash infection risk after severe leg fractures?

NCT ID NCT04597008

Completed Disease control Sponsor: Major Extremity Trauma Research Consortium Source: ClinicalTrials.gov ↗

First seen Feb 28, 2026 · Last updated Jun 23, 2026 · Updated 14 times

Summary

This study tested whether adding tobramycin powder to the standard vancomycin powder in the wound during surgery could reduce deep infections after fixing severe leg fractures. Over 1,500 adults with high-risk tibial plateau or pilon fractures were randomly assigned to receive either vancomycin alone or vancomycin plus tobramycin. The main goal was to see if the combination lowered the rate of infections needing another surgery within six months.

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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

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 placed in the wound during surgery

What this could lead to

If it works, this could lead to a simple, low-cost way to prevent serious infections after high-risk fracture surgery, reducing 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 none compared to vancomycin alone. Results may not apply to all fracture types or patients.

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.

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