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 range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Age range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria