Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag® (NCT05084183) | Clinical Trial Compass
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.
1This trial compares PermeaDerm to Mepilex Ag for thermal burns — can you explain what each of these wound coverings actually does differently, and which one you currently use for my type of burn?
2Since this trial's recruitment status is listed as unknown, is it still actively enrolling patients, and would it even be an option worth pursuing for my situation right now?
3The trial is measuring reepithelialization, meaning how well the skin grows back — based on my burn's depth and location, is that the most important outcome for my recovery, or are there other factors that matter more in my case?
4If I were to participate in this trial, what's the realistic chance I'd be assigned to the dressing you think is better for my burn, and would I have any say in that?
5Are there standard-of-care treatments or other wound management approaches you'd recommend I consider before deciding whether a trial comparing these two dressings is the right path for me?
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.
. 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.