Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®

In- and/or out-patients at ten centers in the United States were included in this investigation. Subjects included were 5 years of age and older who suffered from partial thickness burns. Every patient was followed for 3 weeks.

Inclusion criteria

• Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated)
• Burn of thermal origin
• Both gender with an age ≥ 5 years at randomization
• Signed informed consent
• Subjects who are younger than the legal consenting age must have a legally authorized representative

Exclusion criteria

• - Burns equal to or older than 36 hours
• Burns of chemical and electrical origin
• Clinically infected Burn (as judged by the investigator)
• Treatment of the burn with an active agent before study entry, SSD is allowed up to 24 hours prior to randomization
• Patients with necrotising leucocytic vasculitis or pyoderma gangrenosa.
• Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
• Patients with insulin dependent diabetes mellitus
• Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolon/day or equivalent.
• Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days.
• Known allergy/hypersensitivity to any of the components of the investigation products.
• Patients with physical and/or mental conditions that are not expected to comply with the investigation.
• Participation in other clinical investigation(s) within 1 month prior to start of the investigation
• Pregnancy
• Previously randomised to this investigation