Recruiting

PermeaDerm® & Mepilex Ag®

Sponsor:

Stedical Scientific, Inc.

Code:

NCT05084183

Conditions

Thermal Burn

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

PermeaDerm®

Mepilex Ag

Study Details

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

Study ID

NCT05084183

Start date

Feb 2, 2022

Status verified date

Jun, 2022

Completion date

Nov, 2023

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PermeaDerm®

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

active comparator: Mepilex Ag®

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

Interventions

PermeaDerm®

Wound Management Device

Mepilex Ag

Wound Dressing

Primary outcome measure

  • Reepithelialization [ Time Frame: 14 days ]
  • Alternate therapy [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

More Information

Sponsor

Stedical Scientific, Inc.

Last update posted

Jun 27, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stedical Scientific, Inc. on 2022-06-27.