Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Post Operative Surgical Site Infection, sponsored by Major Extremity Trauma Research Consortium.
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, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed.
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 |
What NCT04678154 shows while recruiting
NCT04678154 is an interventional study that assigns participants to a tested intervention. Its 1,200 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 (55% 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 Standard of care is the first listed.
NCT04678154 names 20 study sites across 14 states, led by 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.
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 NCT04678154's enrollment target sits among peer trials
1,200 220th of 2000 higher than 1,774 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00001987 · 1,200 participants
Genetic Studies of Insulin and Diabetes
- NCT00477100 · 1,200 participants
Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer
- NCT01209000 · 1,200 participants
Nephrotic Syndrome Study Network
- NCT01944332 · 1,200 participants · NA
Gamete Treatment to Correct Fertilization Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI