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

Completed · Not applicable

Conditions studied: Second Degree Burn

In brief

The primary objective is to compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life) of using foam silver dressing (Mepilex® Ag) to a Silver sulfadiazine 1% cream (Silvadene®) from the perspective of the health care provider. The secondary objectives are to investigate the safety, the tolerance and the performance on burn status including pain.

Key facts

Study ID

NCT00742183

Run by

Molnlycke Health Care AB

People needed

100

Starts

2008-08-01

Expected to finish

2009-11-01

Last updated by the study team

2017-12-08

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• - 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

Where it is running

• LA County Hospital & USC Medical Center — Los Angeles, California, United States
• The Burn Center, Washington Hospital Center — Washington D.C., District of Columbia, United States
• Shands Burn Center, University of Florida — Gainesville, Florida, United States
• Joseph Still Burn Center — Augusta, Georgia, United States
• UI Burn Treatment center — Iowa City, Iowa, United States
• Cornell Medical Center — New York, New York, United States
• Paul Silverstein Burn center — Oklahoma City, Oklahoma, United States
• St Christopher's Hospital — Philadelphia, Pennsylvania, United States
• Southwestern Regional Burn Center, Parkland Hospital — Dallas, Texas, United States
• Department of Surgery — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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