Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag®

Study Overview
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Brief Summary
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A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDerm® or Mepilex Ag®. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.

Detailed Description
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A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited from the clinical practices of the site Principal Investigators. Participants and/or the Legally Authorized Representative (LAR) as appropriate will be fully informed regarding the conduct of the clinical trial including all potential risks and benefits. All Participants must be consented, randomized (1:1) and treated within 72 hours of injury. It is permissible for a Study Participant to be enrolled if they have more than one burn wound. If more than one partial thickness burn is treated, the Investigator must indicate prior to randomization which wound is to be considered for primary analysis. This wound will be called the Primary Wound and is to be evaluated by a Blinded Assessor. Additional partial thickness wounds must be treated with the same product to which the Study Participant was randomized and will be included in secondary analysis. These wounds are to be described as Secondary Wounds and are to be evaluated by the Unblinded Assessor. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.

Official Title
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An Adaptive, Randomized, Controlled Trial Evaluating the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag® Used as Standard of Care in the Treatment of Adult and Pediatric Partial Thickness Burns.

Conditions
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Thermal Burn

Intervention / Treatment
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* Device: PermeaDerm®
* Device: Mepilex Ag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be included if all the following criteria are met. Able to give informed consent and undergo treatment < 72 hours of injury (consent may be given by LAR as necessary); Any adult or pediatric patient < 75 years of age; Target burn to be at least one discrete partial thickness (second degree) thermal burns <20% total body surface area (TBSA) on anybody surface except the face; Characteristics of treated wound (s) must be superficial to deep partial thickness wounds such that application of both PermeaDerm and Mepilex Ag is medically appropriate; Agrees to abstain from the use of any other wound covering device for the duration of the study unless determined by the individual site Principal Investigator to be medically necessary; Demonstrates the ability and willingness to follow the requirements of the protocol. Exclusion Criteria: Participants will be excluded if s/he meet any of the following criteria. Pregnant or breastfeeding; Target burn ≥ 20% TBSA; Electrical burns, chemical burns, frostbite; Treatment with silver sulfadiazine prior to presentation; Has comorbidities and/or medications and/or health status that (at the discretion of the individual site Principal Investigator) could result in poor wound healing (some examples may include admission to intensive care unit, inhalation, or other significant burn associated conditions, uncontrolled and/or significant diabetes, peripheral vascular disease, active malignancy, autoimmune disease, smoking, drug abuse, renal failure, steroid usage.

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, single-blinded, adaptive, controlled clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PermeaDerm®<br>N=34 Participants will receive application of PermeaDerm® as outlined in Directions for Use | Device: PermeaDerm®<br>* Wound Management Device<br>|
| Active Comparator: Mepilex Ag®<br>Participants will receive application of Mepilex Ag® as outlined in Directions for Use. | Device: Mepilex Ag<br>* Wound Dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reepithelialization | Time to 100 percent- primary wound | 14 days | 
| Alternate therapy | Time to conversion to alternate therapy- primary wound | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-epithelialization | Percent reepithelialization primary and secondary Wounds | 14 days | 
| Alternate therapy | Time to conversion to alternate therapy- secondary wounds | up to 12 Months | 
| Adverse Events | Occurrence, duration, severity, seriousness, expectedness, and relationship of adverse events | 21 days | 
| Severity of pain | Wong-Backer Faces pain rating scale and in adults as measured by the Numerical Rating Scale (0-10); | Up to 12 Months | 
| Scar characteristics | Patient and Observer Scar Assessment Scale (POSAS) | 6 and 12 months | 
| Satisfaction with treatment | Brisbane Burn Scar Impact Profile (BBSIP) | 6 and 12 months | 
| Dressing Changes Required | Number | Up to 21 Days |