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

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.

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