Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05424354

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

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

60

Participants Needed

6

Research Sites

226 weeks

Total Duration

On this page

Sponsors

U

ULURU Inc.

Lead Sponsor

N

Navy Advanced Medical Development (NAMD) Command

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized patients receiving burn care, with possible outpatient continuation after discharge
  • Men and women aged 18 to 65 years (women must not be pregnant or breastfeeding)
  • Partial thickness burn wounds involving up to 20% of total body surface area
  • Burn injury occurred less than 72 hours before enrollment
  • Willing and able to comply with scheduled study visits and evaluations
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Known allergy to Transforming Powder Dressing or its components
  • Women who are pregnant, breastfeeding, or planning pregnancy during the study
  • Infected burn wounds
  • Presence of any full thickness (third degree) burns
  • Electrical burns
  • Heavily draining burns due to chronic lymphedema or other causes
  • Clinical conditions posing health risks, delaying healing, or affecting study outcome as judged by clinician
  • History of poor wound healing or skin/immune system conditions
  • Clinician deems participant unsuitable
  • Unable or unwilling to provide consent or comply with study visits
  • Developmental disability or psychological disorder impairing consent or participation
  • Active alcohol or substance abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

University of California-Irvine

Orange, California, United States, 92868

Actively Recruiting

2

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

3

Jackson Memorial Hospital UM/JMH Burn Center

Miami, Florida, United States, 33136

Actively Recruiting

4

University of Louisville Health

Louisville, Kentucky, United States, 40202

Actively Recruiting

5

Westchester Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

6

University of Texas SW (Parkland)

Dallas, Texas, United States, 75235

Actively Recruiting

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Research Team

V

Vai Shah

CONTACT

S

Susan St John, MSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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