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Intramedullary Calcium Sulfate Antibiotic Depot
NCT05766670 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.
Conditions Studied
Interventions
- OTHER Standard Intramedullary Nail
- DRUG Vancomycin Hydrochloride
- DRUG Gentamicin
Study Locations (10)
North Carolina
- Atrium Health Carolinas Medical Center — Charlotte
- Atrium Health Cabarrus — Concord
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem
California
- Cedars-Sinai — Los Angeles
Georgia
- Atrium Health Navicent The Medical Center — Macon
Kentucky
- University of Kentucky — Lexington
Louisiana
- Louisiana State University Health Sciences Center — New Orleans
Pennsylvania
- Pennsylvania State University — Hershey
Tennessee
- Vanderbilt University Medical Center — Nashville
Virginia
- Valley Health — Winchester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2024-04-08 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05766670
The ClinicalTrials.gov registry entry for NCT05766670 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 497 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 3 interventions — of which Standard 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: NCT05766670 reports 10 study locations spanning 8 distinct geographic areas — top geographies include North Carolina, California, Georgia. 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 NCT05766670 about?
NCT05766670 is a clinical study titled "Intramedullary Calcium Sulfate Antibiotic Depot". The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care...
What is the current status of trial NCT05766670?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 497 participants. The study started on 2024-04-08. Estimated completion is 2028-01.
What conditions does trial NCT05766670 study?
This clinical trial studies the following conditions: Tibial Fractures, Osteomyelitis Tibia, Open tíbia 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 NCT05766670?
The interventions under investigation include: Standard Intramedullary Nail (OTHER), Vancomycin Hydrochloride (DRUG), Gentamicin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05766670?
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 NCT05766670 being conducted?
This trial has 10 study locations across California, Georgia, Kentucky, Louisiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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