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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: Recruiting Phase 4 study of Tibial Fractures and Osteomyelitis Tibia, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants in each group who develop SSI as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
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 |
What NCT05421741 shows while recruiting
NCT05421741 is an interventional study that assigns participants to a tested intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap, above the 300-participant average among 12 other Tibial Fractures trials with a reported enrollment target (61% higher).
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 lists 14 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Tibial Fractures
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 NCT05421741's enrollment target sits among peer trials
484 4th of 12 higher than 9 of 12 other Tibial Fractures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tibial Fractures 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
-
Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
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-
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-
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RECRUITING · NA
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