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

ULURU Inc.

Status and phase: Active, not recruiting; Phase 4

Conditions: Wounds and Injuries

Treatments: Other: Standard of Care burn dressing; Device: Altrazeal (R) Transforming Powder Dressing

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05424354

U-C-TPD-2021-02

Details and patient eligibility

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 36 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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 36 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Transforming Powder Dressing

Experimental group

Description:

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).

Treatment:

Device: Altrazeal (R) Transforming Powder Dressing

Standard of Care Dressing

Active Comparator group

Description:

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).

Treatment:

Other: Standard of Care burn dressing