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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
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.
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
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).
Time frame: 14 days
Part B
Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).
Time frame: 14 days with 2 visits
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.
Time frame: 14 days with 2 visits
Part B Secondary Outcome.
Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.
Time frame: 14 days with 2 visits
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