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

August 19, 2008
October 11, 2010
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 ] [ 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).
compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life) [ Time Frame: August 2008-August 2009 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00742183 on ClinicalTrials.gov Archive Site
Not Provided
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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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Intervention: Device: Mepilex
  • Active Comparator: Silvadene
    Intervention: Device: Silvadene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00742183
PUMA 415
No
Viktoria Körner, Mölnlycke Health Care AB
Molnlycke Health Care AB
Not Provided
Not Provided
Molnlycke Health Care AB
October 2010

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