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NCT05424354 · ClinicalTrials.gov registry record · Phase 4
Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
A Phase 4 study of Wounds and Injuries, sponsored by ULURU.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 6
- Study locations
NCT05424354: Recruiting Phase 4 study of Wounds and Injuries, sponsored by ULURU.
NCT05424354 is a Phase 4 study of Wounds and Injuries that is actively recruiting participants, run by ULURU. The registered enrollment target is 60 participants, below the 502-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (88% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05424354, a Phase 4 study of Wounds and Injuries, is actively recruiting participants, sponsored by ULURU.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.
Primary Outcome
Subjects will complete a visual analogue scale (VAS) to rate their pain prior to, during and after dressing changes. The scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain possible.
Conditions Studied
Interventions
- DEVICE Altrazeal (R) Transforming Powder Dressing
- OTHER Standard of Care burn dressing
Study Locations (6)
California
- University of California-Irvine - Orange
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- Jackson Memorial Hospital UM/JMH Burn Center - Miami
Kentucky
- University of Louisville Health - Louisville
New York
- Westchester Medical Center - Valhalla
Texas
- University of Texas SW (Parkland) - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-05-26 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 4 |
What NCT05424354 shows while recruiting
NCT05424354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 502-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Wounds and Injuries appearing as the primary indexed condition, and to 2 interventions - of which Altrazeal (R) Transforming Powder Dressing is the first listed.
NCT05424354 lists 6 locations in 6 states (California, District of Columbia, Florida).
Frequently Asked Questions
What is clinical trial NCT05424354 about?
NCT05424354 is a clinical study titled "Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing". This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn inju...
What is the current status of trial NCT05424354?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2022-05-26. Estimated completion is 2026-09-30.
What conditions does trial NCT05424354 study?
This clinical trial studies the following conditions: Wounds and Injuries.
What interventions are being tested in trial NCT05424354?
The interventions under investigation include: Altrazeal (R) Transforming Powder Dressing (DEVICE), Standard of Care burn dressing (OTHER).
Who is sponsoring clinical trial NCT05424354?
This trial is sponsored by ULURU, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05424354 being conducted?
This trial has 6 study locations across California, District of Columbia, Florida, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05424354's enrollment target sits among peer trials
60 23rd of 27 higher than 4 of 27 other Wounds and Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wounds and Injuries 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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