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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorULURU Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Altrazeal (R) Transforming Powder Dressing
  • Standard of Care burn dressing

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

ULURU Inc.

Lead sponsor

Navy Advanced Medical Development (NAMD) Command

Collaborator