Clinical trial NCT05084183: Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag®
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thermal Burn
Lead sponsor: Stedical Scientific, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 68
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-blinded, adaptive, controlled clinical trial.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

Participants will be included if all the following criteria are met.

1. Able to give informed consent and undergo treatment \< 72 hours of injury (consent may be given by LAR as necessary);
2. Any adult or pediatric patient \< 75 years of age;
3. 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;
4. 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;
5. 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;
6. 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.

1. Pregnant or breastfeeding;
2. Target burn ≥ 20% TBSA;
3. Electrical burns, chemical burns, frostbite;
4. Treatment with silver sulfadiazine prior to presentation;
5. 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.

Primary outcomes:
measure: Reepithelialization
timeFrame: 14 days
measure: Alternate therapy
timeFrame: 14 days
Secondary outcomes:
measure: Re-epithelialization
timeFrame: 14 days
measure: Alternate therapy
timeFrame: up to 12 Months
measure: Adverse Events
timeFrame: 21 days
measure: Severity of pain
timeFrame: Up to 12 Months
measure: Scar characteristics
timeFrame: 6 and 12 months
measure: Satisfaction with treatment
timeFrame: 6 and 12 months
measure: Dressing Changes Required
timeFrame: Up to 21 Days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: David Greenhalgh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: