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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Thermal Burn
• Intervention / Treatment: Device: PermeaDerm®; Device: Mepilex Ag

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 Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miao Yu, Ph.D; Phone Number: 1-858-753-9530; Email: miao.yu@stedical.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis
      • Contact: David Greenhalgh, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stedical Scientific, Inc.
• Investigators: Principal Investigator: David Greenhalgh, M.D., University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ST-2021-B001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No