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NCT05421741 · ClinicalTrials.gov registry record · Phase 4
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
A Phase 4 study of Tibial Fractures and Osteomyelitis Tibia, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 484
- Enrollment target
- 14
- Study locations
NCT05421741 is a Phase 4 study of Tibial Fractures and Osteomyelitis Tibia that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 484 participants, above the 300-participant average among 12 other Tibial Fractures trials with a reported enrollment target (61% higher). The trial reports 14 study locations across 8 states.
The verdict
NCT05421741, a Phase 4 study of Tibial Fractures and Osteomyelitis Tibia, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 484 participants
- Enrollment target
- 14
- Study locations
Study Summary
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
Conditions Studied
Interventions
- DRUG Antibiotic coated intramedullary Nail
- OTHER Standard Intramedullary Nail
Study Locations (14)
North Carolina
- University of North Carolina Chapel Hill - Chapel Hill
- Atrium Health Carolinas Medical Center - Charlotte
- Atrium Health Cabarrus - Concord
- Atrium Health Wake Forest Baptist - Winston-Salem
Florida
- University of Florida Gainesville - Gainesville
- Florida Orthopaedic Institute - Temple Terrace
Texas
- University of Texas Houston - Houston
- San Antonio Military Medical Center - San Antonio
Virginia
- Carilion Clinic - Roanoke
- Valley Health System - Winchester
Georgia
- Atrium Health Navicent - Macon
Kentucky
- University of Kentucky - Lexington
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2027-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05421741
The ClinicalTrials.gov registry entry for NCT05421741 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 300-participant average among 12 other Tibial Fractures trials with a reported enrollment target (61% higher). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Tibial Fractures appearing as the primary indexed condition, and to 2 interventions - of which Antibiotic coated intramedullary Nail is the first listed.
NCT05421741 reports 14 study locations spanning 8 distinct geographic areas - top geographies include North Carolina, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05421741 about?
NCT05421741 is a clinical study titled "Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial". This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
What is the current status of trial NCT05421741?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 484 participants. The study started on 2023-05-15. Estimated completion is 2027-12.
What conditions does trial NCT05421741 study?
This clinical trial studies the following conditions: Tibial Fractures, Osteomyelitis Tibia, Open Tibia Fracture.
What interventions are being tested in trial NCT05421741?
The interventions under investigation include: Antibiotic coated intramedullary Nail (DRUG), Standard Intramedullary Nail (OTHER).
Who is sponsoring clinical trial NCT05421741?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05421741 being conducted?
This trial has 14 study locations across Florida, Georgia, Kentucky, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.