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Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
Sponsor: ULURU Inc.
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.
Official title: Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-05-26
Completion Date
2026-09-30
Last Updated
2025-11-19
Healthy Volunteers
Yes
Conditions
Interventions
Altrazeal (R) Transforming Powder Dressing
After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD.
Standard of Care burn dressing
After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with the institution's standard of care burn dressing.
Locations (6)
University of California-Irvine
Orange, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Jackson Memorial Hospital UM/JMH Burn Center
Miami, Florida, United States
University of Louisville Health
Louisville, Kentucky, United States
Westchester Medical Center
Valhalla, New York, United States
University of Texas SW (Parkland)
Dallas, Texas, United States