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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742183
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : November 19, 2010
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Molnlycke Health Care AB

August 19, 2008
August 27, 2008
June 3, 2010
November 19, 2010
December 8, 2017
August 2008
October 2009   (Final data collection date for primary outcome measure)
Compare the Costs of Using the Interventions (Direct and Indirect) [ Time Frame: August 2008-August 2009 ]

The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods.

The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr

compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life) [ Time Frame: August 2008-August 2009 ]
Complete list of historical versions of study NCT00742183 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®
An Open, Parallel, Randomized, Comparative, Multi-centre Investigation in US Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene® in the Treatment of Partial Thickness Burns.

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.

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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Second Degree Burn
  • Device: Mepilex
    Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
  • Device: Silvadene
    Silvadene - dressing changes every day, more frequently if needed
  • Experimental: Mepilex® Ag

    Mepilex® Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment.

    Mepilex® Ag contains silver sulphate that releases silver ions to inactivate a wide range of wound related pathogens (bacteria and fungi), shown in vitro. By reducing the number of microorganisms, Mepilex® Ag may also reduce odour.

    Intervention: Device: Mepilex
  • Active Comparator: Silvadene® Cream 1%
    Silvadene® Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second-and third-degree burns.
    Intervention: Device: Silvadene
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
PUMA 415
Not Provided
Not Provided
Molnlycke Health Care AB
Molnlycke Health Care AB
Not Provided
Principal Investigator: Paul Silverstein Paul Silverstein Burn Center
Molnlycke Health Care AB
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP