a soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients.

Conditions: Burn Injury; Skin Graft

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 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.

Eligibility criteria:
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