Status:
RECRUITING
Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
Lead Sponsor:
ULURU Inc.
Collaborating Sponsors:
Navy Advanced Medical Development (NAMD) Command
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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) dre...
Detailed Description
This post-marketing 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05424354
Start Date
May 26 2022
End Date
September 30 2026
Last Update
November 19 2025
Active Locations (6)
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1
University of California-Irvine
Orange, California, United States, 92868
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Jackson Memorial Hospital UM/JMH Burn Center
Miami, Florida, United States, 33136
4
University of Louisville Health
Louisville, Kentucky, United States, 40202