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

Molnlycke Health Care

Status: Completed

Conditions: Wound Healing; Burns

Treatments: Device: Mepitel Ag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636362

MpT Ag 01

Details and patient eligibility

About

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.

Full description

see Brief summary

Enrollment: 45 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Mepitel Ag

Experimental group

Description:

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

Treatment:

Device: Mepitel Ag