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

NCT05424354 | Recruiting Phase 4 FDA Device

• 1 other identifier: U-C-TPD-2021-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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) 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.

Conditions

Wounds and Injuries

Keywords

burn

Outcome Measures

Primary Outcomes (1)

• Pain from the Burn Wound

  Subjects will complete a visual analogue scale (VAS) to rate their pain prior to, during and after dressing changes. The scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain possible.

  28 days (or sooner if the wound heals prior to 28 days)

Secondary Outcomes (3)

• Wound healing

  28 days (or sooner if the wound heals prior to 28 days)

• Safety of the Interventions (TPD and SOC)

  28 days (or sooner if the wound heals prior to 28 days)

• Subject satisfaction

  End of Study

Study Arms (2)

Transforming Powder Dressing

EXPERIMENTAL

Half of the subjects will be randomized to Transforming Powder Dressing (TPD) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. TPD will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).

Device: Altrazeal (R) Transforming Powder Dressing

Standard of Care Dressing

ACTIVE COMPARATOR

Half of the subjects will be randomized to Standard of Care (SOC) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. The standard of care burn dressing will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).

Other: Standard of Care burn dressing

Interventions

Altrazeal (R) Transforming Powder Dressing DEVICE

After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD.

Transforming Powder Dressing

Standard of Care burn dressing OTHER

After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with the institution's standard of care burn dressing.

Standard of Care Dressing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ULURU Inc.: lead
• Navy Advanced Medical Development (NAMD) Command: collaborator

Study Sites (6)

University of California-Irvine

Orange, California, 92868, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Jackson Memorial Hospital UM/JMH Burn Center

Miami, Florida, 33136, United States

RECRUITING

University of Louisville Health

Louisville, Kentucky, 40202, United States

RECRUITING

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

University of Texas SW (Parkland)

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Burns

Study Officials

• Jonathan Saxe, MD

  ULURU Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vai Shah

CONTACT

2149055145; vshah@uluruinc.com

Susan St John, MSN

CONTACT

4123035379; sstjohn@uluru.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Prospective, Multi-Center, Open Label, Comparison, Human, Interventional

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: May 26, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)