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

Study Overview
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Brief Summary
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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.

Detailed Description
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see Brief summary

Official Title
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An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.

Conditions
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Burns, Wound Healing

Intervention / Treatment
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* Device: Mepitel Ag


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepitel Ag<br>Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. | Device: Mepitel Ag<br>* Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Healed at Day 14. | > = 95 % epitheliazation | Healing will be assessed after 14 days. | 
| Proportion of Subjects Healed at Day 21. | The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21. | Healing will be assessed after 21 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Study Burn Healed. | Percent of study burn healed measured by PictZar photo analysis of tissue types. | At day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial-thickness second degree burns, Mepitel Ag, Silver dressing