Transforming powder dressing versus standard dressing for acute partial-thickness burns
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
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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | ULURU Inc. Industry-sponsored |
| Locations | 6 sites (Orange, California and 5 other locations) |
| Trial ID | NCT05424354 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orange, California and 5 other locations
- 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
- Principal investigator: Jonathan Saxe, MD — ULURU Inc.
- Study coordinator: Vai Shah
- Email: vshah@uluruinc.com
- Phone: 2149055145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.