Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures At High Risk of Infection: TOBRA

Last updated: November 25, 2024
Sponsor: Major Extremity Trauma Research Consortium
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Treatment group

Control group

Clinical Study ID

NCT04597008
W81XWH-19-1-0848
  • Ages 18-80
  • All Genders

Study Summary

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Tibial plateau or tibial pilon fractures that is treated operatively with plate andscrew fixation AND at least one of the following characteristics indicative ofhigher risk of infection:

  2. Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved.

  3. Any open type I, II, or IIIA fracture, regardless of timing of definitivetreatment.

  4. Tibia fracture is associated with ipsilateral leg compartment syndrome andfasciotomy wounds.

  5. Patients ages 18 through 80 years.

Exclusion

Exclusion Criteria:

  1. Study injury is already infected at time of study enrollment.

  2. Definitive fixation of the study injury prior to enrollment in the study.

  3. The patient never receives study fixation.

  4. Massive myonecrosis from ipsilateral leg compartment syndrome.

  5. Currently pregnant.

  6. Severe problems with maintaining follow-up (e.g. patients who are homeless at thetime of injury, those who are intellectually challenged without adequate familysupport, or are unwilling to provide phone and address contact information).

  7. Patients with allergies, drug administration reactions, or other sensitivities toVancomycin (such as a history of Redman's Syndrome).

  8. Patients with allergies, drug administration reactions, or other sensitivities toTobramycin or other aminoglycosides.

Study Design

Total Participants: 1900
Treatment Group(s): 2
Primary Treatment: Treatment group
Phase: 3
Study Start date:
May 11, 2021
Estimated Completion Date:
December 31, 2026

Study Description

Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 182 days of definitive fracture fixation surgery in patients allocated to receive a combination of local Vancomycin and Tobramycin powders compared to patients allocated to local Vancomycin powder.

Sensitivity Analyses: A series of sensitivity analyses will be conducted to look at alternative measures of deep SSI under Specific Aim 1. These sensitivity analyses will consider the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections.

Specific Aim 2: To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.

Connect with a study center

  • University of Alabama Heersink School of Medicine

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

  • _University of California, San Francisco

    San Francisco, California 94110
    United States

    Active - Recruiting

  • Cedars Sinai

    West Hollywood, California 90069
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • St Mary's University/Tenent Health

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Loyola University Chicago

    Chicago, Illinois 60153
    United States

    Active - Recruiting

  • Indiana University School of Medicine - Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana University/Eskenazi Health

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Active - Recruiting

  • LSU Health Sciences

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • University of Maryland Shock Trauma Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland Shock Trauma/Capitol Regions

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Walter Reed Military Medical Center

    Bethesda, Maryland 20889
    United States

    Site Not Available

  • Harvard/Mass General/Brigham Hospitals

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Core Well Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Dartmouth Hitchcock

    Lebanon, New Hampshire 03766
    United States

    Active - Recruiting

  • NYU Langone Orthopedic Hospital

    New York, New York 10016
    United States

    Site Not Available

  • New York Presbyterian/Hospital for Special Surgery

    New York, New York 10021
    United States

    Active - Recruiting

  • NYU Langone Orthopedic Hospital

    New York City, New York 10016
    United States

    Active - Recruiting

  • New York Presbyterian/Hospital for Special Surgery

    New York City, New York 10021
    United States

    Active - Recruiting

  • Jamaica Hospital Medical Center

    Queens, New York 11418
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • METROHealth

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43201
    United States

    Active - Recruiting

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Penn State College of Medicine

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania 19106
    United States

    Active - Recruiting

  • Rhode Island Hospital/Brown University

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Medical University of South Carolina -

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • UTHealth/McGovern Medical School

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Tech University Health Science Center

    Lubbock, Texas 79430
    United States

    Active - Recruiting

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Inova Fairfax MEdical Campus

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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