Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
TOBRA
1 other identifier
interventional
1,550
1 country
41
Brief 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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
May 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedMarch 4, 2026
March 1, 2026
4.2 years
October 15, 2020
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Deep Surgical Site Infection (SSI)
Compare the proportion of deep SSIs of the study injury within 182 days of definitive fracture fixation surgery in patients treated with local Vancomycin powder compared to those treated with a combination of local Vancomycin and Tobramycin powders. For this study a "deep SSI" is a SSI that is treated with operative debridement. In the current CDC terminology this would include all deep organ space, deep incisional, and superficial infections that are treated with surgery.
within 182 days of definitive fracture fixation surgery
Study Arms (2)
Control
ACTIVE COMPARATORStandard 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.
Treatment
EXPERIMENTALStandard 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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:
- Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved.
- Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
- Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds.
- Patients ages 18 through 80 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University of Alabama Heersink School of Medicine
Birmingham, Alabama, 35205, United States
Keck School of Medicine of USC
Los Angeles, California, 90033, United States
Stanford University
Redwood City, California, 94063, United States
_University of California, San Francisco
San Francisco, California, 94110, United States
Cedars Sinai
West Hollywood, California, 90069, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
St Mary's University/Tenent Health
West Palm Beach, Florida, 33407, United States
Loyola University Chicago
Chicago, Illinois, 60153, United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, 46202, United States
Indiana University/Eskenazi Health
Indianapolis, Indiana, 46202, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
LSU Health Sciences
New Orleans, Louisiana, 70112, 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
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, 02115, United States
Core Well Health
Grand Rapids, Michigan, 49503, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, 03766, United States
New York Presbyterian/Hospital for Special Surgery
New York, New York, 10021, United States
Jamaica Hospital Medical Center
Queens, New York, 11418, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute
Charlotte, North Carolina, 28203, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
METROHealth
Cleveland, Ohio, 44109, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43201, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73104, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19106, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Rhode Island Hospital/Brown University
Providence, Rhode Island, 02905, United States
Medical University of South Carolina -
Charleston, South Carolina, 29425, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246, United States
UTHealth/McGovern Medical School
Houston, Texas, 77030, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84108, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Inova Fairfax MEdical Campus
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Related Publications (1)
Schrank GM, O'Hara NN, Lee S, Degani Y, Chung S, Carlini AR, Castillo RC, O'Toole RV. Safety of topical tobramycin powder during operative treatment of fractures. J Antimicrob Chemother. 2025 Sep 3;80(9):2417-2420. doi: 10.1093/jac/dkaf230.
PMID: 40667718DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert V O'Toole, MD, MS
University of Maryland, Department of Orthopaedic Trauma
- PRINCIPAL INVESTIGATOR
Renan C Castillo, PhD
Johns Hopkins Bloomberg School of Public Health
- STUDY DIRECTOR
Anthony R Carlini, MS
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
October 22, 2020
Study Start
May 11, 2021
Primary Completion
July 30, 2025
Study Completion
July 30, 2025
Last Updated
March 4, 2026
Record last verified: 2026-03