RecruitingPhase 4NCT05424354

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

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


Sponsor

ULURU Inc.

Enrollment

60 participants

Start Date

May 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new type of wound dressing called Transforming Powder Dressing (TPD) to standard burn dressings to see which heals partial-thickness burns better and more comfortably. **You may be eligible if:** - You are between 18 and 65 years old - You are being treated for burns in a hospital or outpatient setting - Your burns are partial thickness (not full thickness, meaning the deepest skin layer is intact) - The burned area covers up to 20% of your body surface - Your burn injury occurred within the past 72 hours - You are willing and able to attend follow-up visits **You may NOT be eligible if:** - You are pregnant or breastfeeding - Your wound is already infected - You have full-thickness (third-degree) burns - You have electrical burns - You have a known allergy to TPD or its ingredients - You have a history of poor wound healing or skin/immune conditions - You have active alcohol or substance abuse issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAltrazeal (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.

OTHERStandard 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

View Full Details on ClinicalTrials.gov

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NCT05424354


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