Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
Public ClinicalTrials.gov record NCT04597008. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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").
Study identification
- NCT ID
- NCT04597008
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,660 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 18, 2021 (Actual)
- Primary completion
- Jul 30, 2025 (Actual)
- Completion
- Jul 30, 2025 (Actual)
- Last update posted
- Jul 22, 2026
2021 – 2025
United States locations
- U.S. sites
- 41
- U.S. states
- 26
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Heersink School of Medicine | Birmingham | Alabama | 35205 | — |
| Keck School of Medicine of USC | Los Angeles | California | 90033 | — |
| Stanford University | Redwood City | California | 94063 | — |
| _University of California, San Francisco | San Francisco | California | 94110 | — |
| Cedars Sinai | West Hollywood | California | 90069 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| St Mary's University/Tenent Health | West Palm Beach | Florida | 33407 | — |
| Loyola University Chicago | Chicago | Illinois | 60153 | — |
| Indiana University School of Medicine - Methodist Hospital | Indianapolis | Indiana | 46202 | — |
| Indiana University/Eskenazi Health | Indianapolis | Indiana | 46202 | — |
| University of Kentucky | Lexington | Kentucky | 40506 | — |
| LSU Health Sciences | New Orleans | Louisiana | 70112 | — |
| University of Maryland Shock Trauma Center | Baltimore | Maryland | 21201 | — |
| University of Maryland Shock Trauma/Capitol Regions | Baltimore | Maryland | 21201 | — |
| Harvard/Mass General/Brigham Hospitals | Boston | Massachusetts | 02115 | — |
| Core Well Health | Grand Rapids | Michigan | 49503 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Dartmouth Hitchcock | Lebanon | New Hampshire | 03766 | — |
| New York Presbyterian/Hospital for Special Surgery | New York | New York | 10021 | — |
| Jamaica Hospital Medical Center | Queens | New York | 11418 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute | Charlotte | North Carolina | 28203 | — |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | — |
| METROHealth | Cleveland | Ohio | 44109 | — |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43201 | — |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73104 | — |
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19106 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Rhode Island Hospital/Brown University | Providence | Rhode Island | 02905 | — |
| Medical University of South Carolina - | Charleston | South Carolina | 29425 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| Baylor Scott & White Research Institute | Dallas | Texas | 75246 | — |
| UTHealth/McGovern Medical School | Houston | Texas | 77030 | — |
| UT Health San Antonio | San Antonio | Texas | 78229 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Inova Fairfax MEdical Campus | Falls Church | Virginia | 22042 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04597008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04597008 live on ClinicalTrials.gov.