Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Molnlycke Health Care AB Identifier:
First received: August 19, 2008
Last updated: April 6, 2016
Last verified: October 2010

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 Intervention Phase
Second Degree Burn
Device: Mepilex
Device: Silvadene
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • 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

Enrollment: 100
Study Start Date: August 2008
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mepilex Device: Mepilex
Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
Active Comparator: Silvadene Device: Silvadene
Silvadene - dressing changes every day, more frequently if needed


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00742183

United States, California
LA County Hospital & USC Medical Center
Los Angeles, California, United States, 90033
United States, Florida
Shands Burn Center, University of Florida
Gainsville, 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
The Burn Center, Washington Hospital Center
WashingtonDC, Washington, United States, 20010
Sponsors and Collaborators
Molnlycke Health Care AB
  More Information

Responsible Party: Viktoria Körner, Mölnlycke Health Care AB Identifier: NCT00742183     History of Changes
Other Study ID Numbers: PUMA 415
Study First Received: August 19, 2008
Results First Received: June 3, 2010
Last Updated: April 6, 2016

Additional relevant MeSH terms:
Silver Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents processed this record on April 21, 2017