An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients

A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20 subjects from 2 centres in the US, presenting with the need for surgical intervention and grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site designated as a "study site".

Inclusion criteria

• Surgical donor sites for deep partial-thickness or full-thickness burns
• Burn of thermal origin
• Both genders with an age ≥ 7 years at enrolment
• 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

• Any known or suspected systemic infection
• Any known sensitivity to silver or other components/products used in this study.
• Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a malignant disease in the past, was treated with the expectation of a cure and is currently disease-free, may be considered for study entry.
• Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation.
• Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
• Requires immersion hydrotherapy at any time during study participation (note, showering hydrotherapy is allowed).
• Subject unwilling to comply with 28 day follow-up.
• Participation in another investigational study while participating in this study.
• Bleeding disorders