Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Molnlycke Health Care AB
see Brief summary
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns
