Actively Recruiting
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
Eligibility Criteria
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
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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