A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns (NCT01636362) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns
United States45 participantsStarted 2012-08
Plain-language summary
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
Who can participate
Age range
2 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:
* Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
* Study site is from 1-15% BSA
* Study site is a single, isolated burn area
* From 2 years and above
* Thermal burn injury
* Signed Informed Consent/Assent Form
* Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.
Exclusion Criteria:
* Completely non-exuding or dry wound bed at study site
* Full thickness \>5%
* Burn greater than 24 hrs old
* Burns to face or neck
* Suspicion of infection of study burn
* Use of chemical/enzymatic and biological debridement within 7 days of investigation start
* Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
* Subject with lung injury or subject being on a ventilator
* Subject with dermatologic skin disorders or necrotizing processes
* Subject with insulin dependent diabetes mellitus
* Electrical, chemical etiology
* Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
* Non-compliant subject
* Subject previously included in this investigation
* Subject included in other ongoing clinical investigation at present or during the past 30 days.
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
1
Number of Subjects Healed at Day 14.
Timeframe: Healing will be assessed after 14 days.
2
Proportion of Subjects Healed at Day 21.
Timeframe: Healing will be assessed after 21 days.