Status:
COMPLETED
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Burn Injury
Skin Graft
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 gra...
Detailed Description
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 investiga...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02210208
Start Date
September 1 2014
End Date
June 15 2016
Last Update
January 10 2018
Active Locations (4)
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1
The Arizona Burn Center
Phoenix, Arizona, United States, 85008
2
The University of South Florida Board of Trustees
Orlando, Florida, United States, 32886-4687
3
Long Island Plastic Surgical Group
New York, New York, United States, 11530
4
St. Chrisopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134