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

NCT05084183 | Unknown FDA Device

• 1 other identifier: ST-2021-B001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Thermal Burn

Outcome Measures

Primary Outcomes (2)

• Reepithelialization

  Time to 100 percent- primary wound

  14 days

• Alternate therapy

  Time to conversion to alternate therapy- primary wound

  14 days

Secondary Outcomes (7)

• Re-epithelialization

  14 days

• Alternate therapy

  up to 12 Months

• Adverse Events

  21 days

• Severity of pain

  Up to 12 Months

• Scar characteristics

  6 and 12 months

Study Arms (2)

PermeaDerm®

EXPERIMENTAL

N=34 Participants will receive application of PermeaDerm® as outlined in Directions for Use

Device: PermeaDerm®

Mepilex Ag®

ACTIVE COMPARATOR

Participants will receive application of Mepilex Ag® as outlined in Directions for Use.

Device: Mepilex Ag

Interventions

PermeaDerm® DEVICE

Wound Management Device

PermeaDerm®

Mepilex Ag DEVICE

Wound Dressing

Mepilex Ag®

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stedical Scientific, Inc.: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

Study Officials

• David Greenhalgh, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miao Yu, Ph.D

CONTACT

1-858-753-9530; miao.yu@stedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is intended that blinded assessment of wounds will be performed at 14 days after treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, single-blinded, adaptive, controlled clinical trial.

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 19, 2021
• Study Start: February 2, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)