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

NCT ID: NCT05424354

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2026-09-30

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.

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 care (SOC) dressing for burn wounds. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, comprising 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 during hospitalization and then upon discharge from the hospital for up to 28 days after enrollment into the study. At each of the 8 study visits, the burn wound will be evaluated, photographed and measured. The wound will be cleaned and debrided, if needed, per usual standard burn care. A wound dressing will be applied using TPD or a typical SOC dressing. Wound healing and wound pain will be monitored at each visit, and the results of the two groups (TPD and SOC) will be compared to each other. A survey evaluating the satisfaction with the dressing received will be given at the end of the study, or when the wound heals, whichever comes first.

Conditions

Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transforming Powder Dressing

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).

Group Type: EXPERIMENTAL

Altrazeal (R) Transforming Powder Dressing

Intervention Type: 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.

Standard of Care Dressing

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).

Group Type: ACTIVE_COMPARATOR

Standard of Care burn dressing

Intervention Type: 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.

Interventions

Altrazeal (R) Transforming Powder Dressing

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.

Intervention Type: DEVICE

Standard of Care burn dressing

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Navy Advanced Medical Development (NAMD) Command

UNKNOWN

Sponsor Role: collaborator

ULURU Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Saxe, MD

Role: PRINCIPAL_INVESTIGATOR

ULURU Inc.

Locations

University of California-Irvine

Orange, California, United States

Site Status: RECRUITING

MedStar Washington Hospital Center

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

Site Status: RECRUITING

Jackson Memorial Hospital UM/JMH Burn Center

Miami, Florida, United States

Site Status: RECRUITING

University of Louisville Health

Louisville, Kentucky, United States

Site Status: RECRUITING

Westchester Medical Center

Valhalla, New York, United States

Site Status: RECRUITING

University of Texas SW (Parkland)

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vai Shah

Role: CONTACT

vshah@uluruinc.com

2149055145

Susan St John, MSN

Role: CONTACT

sstjohn@uluru.com

4123035379

Facility Contacts

Lizette Spears

Role: primary

lspiers@hs.uci.edu

714-456-5840

Taina Aruju

Role: backup

taraujo@hs.uci.edu

714-456-5840

Mary (Abby) Bellon

Role: primary

Mary.A.Bellon@medstar.net

202 877 3519

Lisa Otero, BA

Role: primary

lao77@med.miami.edu

305-585-1348

Madison Rutledge

Role: primary

madison.rutledge@louisville.edu

(502) 629-3327

Michelle Broers

Role: backup

michelle.broers@uoflhealth.org

Daniela Santamaria-Vargas, MSc

Role: primary

Daniela.Santamaria-Vargas@wmchealth.org

9144931528

Falyn Katzman, MPH

Role: backup

falyn.katzman@wmchealth.org

Scarlett Dwyer

Role: primary

Scarlett.Dwyer@utsouthwestern.edu

214 645-0445

Other Identifiers

U-C-TPD-2021-02

Identifier Type: -

Identifier Source: org_study_id