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

This study has been completed.
Sponsor:
Information provided by:
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT00742183
First received: August 19, 2008
Last updated: October 11, 2010
Last verified: October 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Burns
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    The incremental cost-effectiveness ratio was used to estimate the cost per unit of effectiveness with the use of one treatment (Mepilex AG dressing) in place of another (silver sulfadiazine).


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

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742183

Locations
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

No publications provided

Responsible Party: Viktoria Körner, Mölnlycke Health Care AB
ClinicalTrials.gov 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: October 11, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Silver Sulfadiazine
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013