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Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID05424354

Phase IV Trial Comparing Altrazeal Transforming Powder Dressing to Standard Burn Dressings for Adults with Acute Partial Thickness Burns

Led by ULURU Inc. · Updated on 2025-11-19

60

Participants Needed

6

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of Altrazeal Transforming Powder Dressing TPD compared to the current standard of care SOC dressing in adult patients with partial thickness burn wounds. This study focuses on adults aged 18 to 65 who are hospitalized with acute burns covering less than 20% of their total body surface area. The burns must be recent, occurring less than 72 hours before enrollment. The purpose is to compare wound healing, pain, and patient satisfaction between the two dressing types in a controlled clinical setting. Participants will be randomly assigned to one of two groups one receiving the Transforming Powder Dressing and the other receiving the standard burn care dressing. Both groups will have their wounds treated and dressed accordingly during each visit. Visits are scheduled on treatment days 0, 3, 7, 10, 14, 21, and 28, or earlier if the wound heals before day 28. Each visit includes wound cleaning, assessment, photography, and dressing application, with a secondary dressing used over the primary dressing. Participants will be monitored closely throughout hospitalization and after discharge for up to 28 days. At each of the eight study visits, wound healing and pain will be evaluated and recorded. Researchers will also assess safety and collect patient feedback through a satisfaction survey at the end of the study or upon wound healing. The primary outcome is the level of pain from the burn wound, with secondary outcomes including wound healing progress and safety of the dressings.

CONDITIONS

Brief Title

Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing

Research Team

V

Vai Shah

S

Susan St John, MSN

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