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

Brief Summary:

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.

Condition or disease Intervention/treatment
Second Degree Burn Device: Mepilex Device: Silvadene

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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.
Study Start Date : August 2008
Primary Completion Date : October 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arm Intervention/treatment
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.

Device: Mepilex
Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
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.
Device: Silvadene
Silvadene - dressing changes every day, more frequently if needed

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742183

United States, California
LA County Hospital & USC Medical Center
Los Angeles, California, United States, 90033
United States, District of Columbia
The Burn Center, Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Shands Burn Center, University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Joseph Still Burn Center
Augusta, Georgia, United States, 30909
United States, Iowa
UI Burn Treatment center
Iowa City, Iowa, United States, 52242
United States, New York
Cornell Medical Center
New York, New York, United States, 10065
United States, Oklahoma
Paul Silverstein Burn center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
St Christopher's Hospital
Philadelphia, Pennsylvania, United States, 19134
United States, Texas
Southwestern Regional Burn Center, Parkland Hospital
Dallas, Texas, United States, 75235
United States, Washington
Department of Surgery
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Molnlycke Health Care AB
Principal Investigator: Paul Silverstein Paul Silverstein Burn Center

Responsible Party: Molnlycke Health Care AB Identifier: NCT00742183     History of Changes
Other Study ID Numbers: PUMA 415
First Posted: August 27, 2008    Key Record Dates
Results First Posted: November 19, 2010
Last Update Posted: December 8, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Silver Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents