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

Not Applicable

• Conditions: Thermal Burn
• Interventions: Device: PermeaDerm®; Device: Mepilex Ag

• Registration Number: NCT05084183
• Lead Sponsor: Stedical Scientific, Inc.

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.

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2022-02-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-27
• Primary Completion: 2022-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PermeaDerm®	PermeaDerm®	N=34 Participants will receive application of PermeaDerm® as outlined in Directions for Use
Mepilex Ag®	Mepilex Ag	Participants will receive application of Mepilex Ag® as outlined in Directions for Use.

Primary Outcome Measures

Name	Time	Method
Alternate therapy	14 days	Time to conversion to alternate therapy- primary wound
Reepithelialization	14 days	Time to 100 percent- primary wound

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States