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NCT06223269 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
A Phase 3 study of Wound Heal and Burns Degree Third, sponsored by XenoTherapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT06223269: Recruiting Phase 3 study of Wound Heal and Burns Degree Third, sponsored by XenoTherapeutics.
NCT06223269 is a Phase 3 study of Wound Heal and Burns Degree Third that is actively recruiting participants, run by XenoTherapeutics. The registered enrollment target is 50 participants, below the 118-participant average among 23 other Wound Heal trials with a reported enrollment target (58% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06223269, a Phase 3 study of Wound Heal and Burns Degree Third, is actively recruiting participants, sponsored by XenoTherapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.
Primary Outcome
Complete wound closure is defined as \>95% skin re-epithelization in an area of the treatment site without drainage or dressing requirements by Post-Treatment Day 28 (± 7 days). Durable wound closure is defined as confirmation of complete wound closure in an area of the treatment site at two consecutive evaluations, spaced by no less than 14 days and no more than 5 months. Post-Treatment is defined as time elapsed following autografting and treatment with realSKIN, and is not necessarily time
Conditions Studied
Interventions
- DRUG Skin Xenotransplant
- PROCEDURE Autograft(ing)
Study Locations (4)
Arizona
- Arizona Burn Center Valleywise Health - Phoenix
Georgia
- JMS Burn Center at Doctors Hospital - Augusta
Maine
- MaineHealth Maine Medical Center - Portland
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-05-09 |
| Est. Completion | 2026-01 |
| Phase | Phase 3 |
What NCT06223269 shows while recruiting
NCT06223269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 118-participant average among 23 other Wound Heal trials with a reported enrollment target (58% lower).
The record links to 5 conditions, with Wound Heal appearing as the primary indexed condition, and to 2 interventions - of which Skin Xenotransplant is the first listed.
NCT06223269 reports a single indexed study location in Arizona, Georgia, Maine.
Frequently Asked Questions
What is clinical trial NCT06223269 about?
NCT06223269 is a clinical study titled "Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting". To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.
What is the current status of trial NCT06223269?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2024-05-09. Estimated completion is 2026-01.
What conditions does trial NCT06223269 study?
This clinical trial studies the following conditions: Wound Heal, Burns Degree Third, Burn (Disorder), Burn Degree Second, Thermal Burn.
What interventions are being tested in trial NCT06223269?
The interventions under investigation include: Skin Xenotransplant (DRUG), Autograft(ing) (PROCEDURE).
Who is sponsoring clinical trial NCT06223269?
This trial is sponsored by XenoTherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06223269 being conducted?
This trial has 4 study locations across Arizona, Georgia, Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06223269's enrollment target sits among peer trials
50 13th of 23 higher than 9 of 23 other Wound Heal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wound Heal 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.
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