Health TrialsbyHealthPanel

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

ConditionWounds and Injuries
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard of Care burn dressing

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Transforming Powder DressingExperimental treatment 1 intervention
Group B: Standard of Care DressingActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Wound healing

Wounds will measured at each study visit to determine surface area healing.

Time frame
28 days (or sooner if the wound heals prior to 28 days)
2

Safety of the Interventions (TPD and SOC)

Complications such as infection, and other adverse events that develop will be documented, evaluated for severity, and compared between intervention groups.

Time frame
28 days (or sooner if the wound heals prior to 28 days)
3

Subject satisfaction

Subjects will be asked to complete a subject satisfaction survey, which consists of 8 multiple choice questions regarding their wound dressing.

Time frame
End of Study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ULURU Inc.

Lead sponsor

Navy Advanced Medical Development (NAMD) Command

Collaborator

Source ClinicalTrials.gov
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