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RECRUITING
NCT05424354
PHASE4

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

Sponsor: ULURU Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

OTHER

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