UnknownNot Applicable

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

United States68 participantsStarted 2022-02-02

Plain-language 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.

Who can participate

Age range75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion 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.

What they're measuring

Reepithelialization

Timeframe: 14 days

Alternate therapy

Timeframe: 14 days

Trial details

NCT IDNCT05084183

SponsorStedical Scientific, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11

Contact for this trial

Miao Yu, Ph.D

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

View on ClinicalTrials.gov More Thermal Burn trials