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

Completed · Not applicable

Conditions studied: Burn Injury, Skin Graft

In brief

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.

Key facts

Study ID

NCT02210208

Run by

Molnlycke Health Care AB

People needed

25

Starts

2014-09-01

Expected to finish

2016-06-15

Last updated by the study team

2018-01-10

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Arizona Burn Center — Phoenix, Arizona, United States
• The University of South Florida Board of Trustees — Orlando, Florida, United States
• Long Island Plastic Surgical Group — New York, New York, United States
• St. Chrisopher's Hospital for Children — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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