A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.

Study Overview
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Brief Summary
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Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients. Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.

Detailed Description
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This post market clinical follow-up investigation is designed as an open, non-controlled, multi- centre, clinical investigation. A total of approximately 25 subjects from among 4-6 clinical investigative sites will be evaluated providing they fulfill all the inclusion criteria and none of the exclusion criteria. A signed and dated informed consent/assent will be obtained for all subjects. Subjects to be included will present with a thermal burn injury that will require skin grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned will not exceed 30%. The subjects will be consecutively allocated to a subject code providing they fulfill all inclusion criteria and none of the exclusion criteria and have signed a written consent. The subjects were participating in the study for 14 days postop.

Official Title
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An Open, Non-controlled, Multi-centre, Clinical Investigation to Verify Performance and Safety of a Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients and the Usefulness of a Marketed Donor Site Dressing.

Conditions
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Burn Injury, Skin Graft

Intervention / Treatment
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* Device: Mepitel® Ag
* Device: Mepilex® Transfer Ag


Participation Criteria
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Eligibility Criteria
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Part A Inclusion Criteria Subjects with burn injury resulting in up to 30% TBSA Full thickness area of burn should not be more than 20% Area in need of skin grafting can be 1-15% TBSA Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product Thermal injuries only Subjects age 18 months to < 65 years. Signed informed consent 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 Greater than 30% TBSA Full thickness areas greater than 20% TBSA Full thickness area to be grafted less than 1% Presence of respiratory involvement Subjects on mechanical ventilation Subjects with infected burn wounds Subjects with organ failure Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by the investigator to be a potential interference in the treatment Subjects treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone/day or equivalent Known allergy/hypersensitivity to any of the components of the investigation products. Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including patients totally confined to bed Participation in other clinical investigation(s) within 1 month prior to start of the investigation Previous randomized to this investigation Part B Inclusion Criteria -There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm) Exclusion Criteria Investigator do not agree to treat the donor site with Mepilex Transfer Ag The subject do not agree to participate in the donor site part

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepitel® Ag<br>A dressing device used for surgical burn wounds with skin graft. | Device: Mepitel® Ag<br>* A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties. This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing.<br>|
| Experimental: Mepilex® Transfer Ag<br>Donor site dressing device in the very same patient. | Device: Mepilex® Transfer Ag<br>* Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex® Transfer Ag consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Number of Participants With Healing | Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator). | 14 days | 
| Part B | Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis). | 14 days with 2 visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A Secondary Outcome. | Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit. Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing. | 14 days with 2 visits | 
| Part B Secondary Outcome. | Ability of Mepilex® Transfer Ag to adhere to donor site without slippage. | 14 days with 2 visits |