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NCT04597008 · ClinicalTrials.gov registry record · Phase 3
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
A Phase 3 study of Post Operative Surgical Site Infection, sponsored by Major Extremity Trauma Research Consortium.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,550
- Enrollment target
- 20
- Study locations
NCT04597008: Completed Phase 3 study of Post Operative Surgical Site Infection, sponsored by Major Extremity Trauma Research Consortium.
NCT04597008 is a Phase 3 study of Post Operative Surgical Site Infection that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 1,550 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04597008, a Phase 3 study of Post Operative Surgical Site Infection, has completed, sponsored by Major Extremity Trauma Research Consortium.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,550 participants
- Enrollment target
- 20
- Study locations
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").
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Treatment group
- DRUG Control group
Study Locations (20)
California
- Keck School of Medicine of USC - Los Angeles
- Stanford University - Redwood City
- _University of California, San Francisco - San Francisco
- Cedars Sinai - West Hollywood
Indiana
- Indiana University School of Medicine - Methodist Hospital - Indianapolis
- Indiana University/Eskenazi Health - Indianapolis
Maryland
- University of Maryland Shock Trauma Center - Baltimore
- University of Maryland Shock Trauma/Capitol Regions - Baltimore
Alabama
- University of Alabama Heersink School of Medicine - Birmingham
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Florida
- St Mary's University/Tenent Health - West Palm Beach
Illinois
- Loyola University Chicago - Chicago
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,550 participants |
| Start Date | 2021-05-11 |
| Est. Completion | 2025-07-30 |
| Phase | Phase 3 |
What the finished NCT04597008 record still lists
NCT04597008 is an interventional study that assigns participants to a tested intervention. Its 1,550 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (101% higher).
The record links to 1 condition, with Post Operative Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Treatment group is the first listed.
NCT04597008 names 20 study sites across 15 states, led by California, Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT04597008 about?
NCT04597008 is a clinical study titled "Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA". 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").
What is the current status of trial NCT04597008?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,550 participants. The study started on 2021-05-11. Estimated completion is 2025-07-30.
What conditions does trial NCT04597008 study?
This clinical trial studies the following conditions: Post Operative Surgical Site Infection.
What interventions are being tested in trial NCT04597008?
The interventions under investigation include: Treatment group (DRUG), Control group (DRUG).
Who is sponsoring clinical trial NCT04597008?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04597008 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Operative Surgical Site Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04597008's enrollment target sits among peer trials
1,550 150th of 2000 higher than 1,851 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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