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Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing

ULURU Inc. · with Navy Advanced Medical Development (NAMD) Command · NCT05424354

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
60
US sites recruiting
6
Study start
May 26, 2022
Record last updated
November 19, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.

Being studied: Altrazeal (R) Transforming Powder Dressing; Standard of Care burn dressing

Conditions: Wounds and Injuries

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of California-Irvine

    Orange, CA 92868

    Site contact: Lizette Spears · 714-456-5840 · lspiers@hs.uci.edu

  • MedStar Washington Hospital Center

    Washington D.C., DC 20010

    Site contact: Mary (Abby) Bellon · 202 877 3519 · Mary.A.Bellon@medstar.net

  • Jackson Memorial Hospital UM/JMH Burn Center

    Miami, FL 33136

    Site contact: Lisa Otero, BA · 305-585-1348 · lao77@med.miami.edu

  • University of Louisville Health

    Louisville, KY 40202

    Site contact: Madison Rutledge · (502) 629-3327 · madison.rutledge@louisville.edu

  • Westchester Medical Center

    Valhalla, NY 10595

    Site contact: Daniela Santamaria-Vargas, MSc · 9144931528 · Daniela.Santamaria-Vargas@wmchealth.org

  • University of Texas SW (Parkland)

    Dallas, TX 75235

    Site contact: Scarlett Dwyer · 214 645-0445 · Scarlett.Dwyer@utsouthwestern.edu

Study contacts (from the official record)

  • Vai Shah · 2149055145 · vshah@uluruinc.com
  • Susan St John, MSN · 4123035379 · sstjohn@uluru.com
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Acute Partial Thickness Burn Study Comparing Transforming Powder… (NCT05424354) | Bored Studies