Clinical trial Recruiting at 6 sites Phase 4 Interventional Ages 18 to 65

Transforming powder dressing versus standard dressing for acute partial-thickness burns

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

Run by ULURU Inc. · NCT05424354 · Data updated 2026-11-12

This trial tests whether the Altrazeal transforming powder dressing helps adults with recent partial-thickness burns heal faster and with less pain than standard dressings.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorULURU Inc.
Industry-sponsored
Locations6 sites (Orange, California and 5 other locations)
StatusRecruiting
StartedMay 26, 2022
Main results expectedJune 30, 2026
Study endsSeptember 30, 2026
Registry record updatedNovember 19, 2025
Trial IDNCT05424354 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 hospitalized with an acute (within 72 hours) partial-thickness burn covering less than 20% total body surface area, without infection, and able to attend scheduled follow-up visits are ideal candidates.

Probably not a fit

Patients with full-thickness or infected burns, electrical burns, heavily draining wounds, pregnant or breastfeeding individuals, those outside the 18–65 age range, or burns exceeding 20% TBSA are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled post-marketing trial enrolls adults 18–65 hospitalized with an acute partial-thickness burn involving under 20% total body surface area. Participants are randomized 1:1 to receive either the Altrazeal transforming powder dressing or a typical standard-of-care burn dressing, with wound cleaning and debridement per usual burn care. Wounds are photographed, measured, and monitored for healing and pain across up to eight visits during hospitalization and up to 28 days after enrollment. A patient satisfaction survey about the dressing is completed when the wound heals or at the end of follow-up.

Why it matters

Potential benefit: If successful, this dressing could speed healing, reduce wound pain, and make dressing changes easier for people with partial-thickness burns.

How similar studies have gone: Some small clinical reports and post-marketing experience suggest transforming powder dressings can support healing in partial-thickness wounds, but few large randomized comparisons to standard burn dressings exist.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
* Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
* Wounds must be partial thickness, involving up to 20% of the total body surface area.
* Burn injury should be less than 72 hours old
* Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Known allergy to TPD or its components

  * Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
* Infected wounds
* Presence of any full thickness (third degree) burns
* Electrical burns
* Heavily draining burns due to underlying chronic lymphedema or other conditions
* Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.
* History of poor wound healing and/or skin/immune system condition

  * Deemed by clinician not to be suitable
* Unwilling or not able to provide consent or comply with protocol or required visits
* Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol
* Active alcohol or substance abuse

Where it's running

  • University of California-Irvine
    Orange, California, United States
    Recruiting
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia, United States
    Recruiting
  • Jackson Memorial Hospital UM/JMH Burn Center
    Miami, Florida, United States
    Recruiting
  • University of Louisville Health
    Louisville, Kentucky, United States
    Recruiting
  • Westchester Medical Center
    Valhalla, New York, United States
    Recruiting
  • University of Texas SW (Parkland)
    Dallas, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.