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Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
Sponsor: Major Extremity Trauma Research Consortium
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").
Official title: Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1660
Start Date
2021-06-18
Completion Date
2025-07-30
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
Treatment group
Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed, which is placed right before wound closure at the final stafe of definitive fracture fixation.
Control group
Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation.
Locations (41)
University of Alabama Heersink School of Medicine
Birmingham, Alabama, United States
Keck School of Medicine of USC
Los Angeles, California, United States
Stanford University
Redwood City, California, United States
_University of California, San Francisco
San Francisco, California, United States
Cedars Sinai
West Hollywood, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
St Mary's University/Tenent Health
West Palm Beach, Florida, United States
Loyola University Chicago
Chicago, Illinois, United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, United States
Indiana University/Eskenazi Health
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
LSU Health Sciences
New Orleans, Louisiana, United States
University of Maryland Shock Trauma Center
Baltimore, Maryland, United States
University of Maryland Shock Trauma/Capitol Regions
Baltimore, Maryland, United States
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, United States
Core Well Health
Grand Rapids, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
New York Presbyterian/Hospital for Special Surgery
New York, New York, United States
Jamaica Hospital Medical Center
Queens, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
METROHealth
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Penn State College of Medicine
Hershey, Pennsylvania, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital/Brown University
Providence, Rhode Island, United States
Medical University of South Carolina -
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
UTHealth/McGovern Medical School
Houston, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax MEdical Campus
Falls Church, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States