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NCT04678154 · ClinicalTrials.gov registry record · Phase 3
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
A Phase 3 study of Post Operative Surgical Site Infection, sponsored by Major Extremity Trauma Research Consortium.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT04678154 is a Phase 3 study of Post Operative Surgical Site Infection that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 1,200 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT04678154, a Phase 3 study of Post Operative Surgical Site Infection, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.
Conditions Studied
Interventions
- DRUG Standard of care
- DRUG Vancomycin and Tobramycin
Study Locations (20)
California
- Stanford University - Redwood City
- _University of California, San Francisco - San Francisco
- University of California at San Francisco - San Francisco
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Atrium Health Carolinas Medical Center - Charlotte
- Atrium Health Wake Forest Baptist - Winston-Salem
Indiana
- Indiana University School of Medicine - Methodist Hospital - Indianapolis
- Indiana University/Eskenazi Health - Indianapolis
Maryland
- University of Maryland , MD Department of Orthopaedics - Baltimore
- Walter Reed Military Medical Center - Bethesda
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Florida
- St Mary's University/Tenent Health - West Palm Beach
Georgia
- Emory University School of Medicine - Atlanta
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2021-05-07 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04678154
The ClinicalTrials.gov registry entry for NCT04678154 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Major Extremity Trauma Research Consortium, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Operative Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Standard of care is the first listed.
NCT04678154 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, North Carolina, Indiana.
Frequently Asked Questions
What is clinical trial NCT04678154 about?
NCT04678154 is a clinical study titled "Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT". The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.
What is the current status of trial NCT04678154?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2021-05-07. Estimated completion is 2027-03-31.
What conditions does trial NCT04678154 study?
This clinical trial studies the following conditions: Post Operative Surgical Site Infection.
What interventions are being tested in trial NCT04678154?
The interventions under investigation include: Standard of care (DRUG), Vancomycin and Tobramycin (DRUG).
Who is sponsoring clinical trial NCT04678154?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04678154 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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