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NCT05766670 · ClinicalTrials.gov registry record · Phase 3
Intramedullary Calcium Sulfate Antibiotic Depot
A Phase 3 study of Tibial Fractures and Osteomyelitis Tibia, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 497
- Enrollment target
- 10
- Study locations
NCT05766670 is a Phase 3 study of Tibial Fractures and Osteomyelitis Tibia that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 497 participants, above the 299-participant average among 12 other Tibial Fractures trials with a reported enrollment target (66% higher). The trial reports 10 study locations across 8 states.
The verdict
NCT05766670, a Phase 3 study of Tibial Fractures and Osteomyelitis Tibia, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 497 participants
- Enrollment target
- 10
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 497 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 299-participant average among 12 other Tibial Fractures trials with a reported enrollment target (66% 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 3 interventions - of which Standard Intramedullary Nail is the first listed.
NCT05766670 reports 10 study locations spanning 8 distinct geographic areas - top geographies include North Carolina, California, Georgia.
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.
What interventions are being tested in trial NCT05766670?
The interventions under investigation include: Standard Intramedullary Nail (OTHER), Vancomycin Hydrochloride (DRUG), Gentamicin (DRUG).
Who is sponsoring clinical trial NCT05766670?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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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Related
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