Actively Recruiting

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

Prospective Randomized Open Label Multicenter Study Comparing Altrazeal Transforming Powder Dressing to Standard of Care in Acute Partial Thickness Burn Wounds

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

60

Participants Needed

6

Research Sites

13 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

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized patients receiving burn care, who may continue treatment as outpatients when clinically stable
  • Men and women aged 18 to 65 years (women cannot be pregnant or breastfeeding)
  • Partial thickness burn wounds involving up to 20% of total body surface area
  • Burn injury less than 72 hours old
  • 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 plan to become pregnant during the study
  • Infected wounds
  • Presence of any full thickness (third degree) burns
  • Electrical burns
  • Heavily draining burns due to chronic lymphedema or other conditions
  • Concurrent clinical conditions posing health risks, delaying wound healing, or affecting study outcomes
  • History of poor wound healing or skin/immune system conditions
  • Clinician judgment deeming the patient unsuitable
  • Unable or unwilling to provide consent or comply with protocol and visits
  • Developmental disability or significant 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 28 days or until the wound heals

Participants receive burn wound care with either the Transforming Powder Dressing (TPD) or the Standard of Care dressing. Wound care is performed on each study visit including cleaning, debridement if needed, and dressing application. Wound healing and pain are monitored throughout.

8 visits on Days 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals)

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

S

Susan St John, MSN

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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