A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Mepitel Ag	Mepitel Ag	Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Healed at Day 14.	Healing will be assessed after 14 days.	\> = 95 % epitheliazation
Proportion of Subjects Healed at Day 21.	Healing will be assessed after 21 days.	The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.

Secondary Outcome Measures

Name	Time	Method
Percent of Study Burn Healed.	At day 21	Percent of study burn healed measured by PictZar photo analysis of tissue types.

Locations (6): Wishard
🇺🇸
Indianapolis, Indiana, United States
Arizona Burn Center
🇺🇸
Phoenix, Arizona, United States
Harborview Medical Center
🇺🇸
Seattle, Washington, United States
Paul Silverstein, MD
🇺🇸
Oklahoma City, Oklahoma, United States
S:t Christopher's Hospital for Children
🇺🇸
Philadelphia, Pennsylvania, United States
Orlando Regional Medical Center
🇺🇸
Orlando, Florida, United States