Clinical trial NCT05424354: Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
Official title: Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Wounds and Injuries
Keywords: burn
Lead sponsor: ULURU Inc.
Sponsor class: INDUSTRY
Collaborators: name: Navy Advanced Medical Development (NAMD) Command
First posted: 2022-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Prospective, Multi-Center, Open Label, Comparison, Human, Interventional
Primary purpose: TREATMENT

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 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.

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.

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 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

Primary outcomes:
measure: Pain from the Burn Wound
timeFrame: 28 days (or sooner if the wound heals prior to 28 days)
Secondary outcomes:
measure: Wound healing
timeFrame: 28 days (or sooner if the wound heals prior to 28 days)
measure: Safety of the Interventions (TPD and SOC)
timeFrame: 28 days (or sooner if the wound heals prior to 28 days)
measure: Subject satisfaction
timeFrame: End of Study
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Dallas
country: United States
facility: University of Texas SW (Parkland)
state: Texas
Study officials:
affiliation: ULURU Inc.
name: Jonathan Saxe, MD
role: PRINCIPAL_INVESTIGATOR
References: