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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
NCT05421741 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05421741 reports 14 study locations spanning 8 distinct geographic areas — top geographies include North Carolina, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05421741?
The interventions under investigation include: Antibiotic coated intramedullary Nail (DRUG), Standard Intramedullary Nail (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05421741?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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