Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex� Ag Versus Silvadene�
Information source: Molnlycke Health Care AB
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Second Degree Burn
Intervention: Mepilex (Device); Silvadene (Device)
Phase: Phase 4
Status: Completed
Sponsored by: Molnlycke Health Care AB
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: Compare the Costs of Using the Interventions (Direct and Indirect)
Eligibility
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
LA County Hospital & USC Medical Center, Los Angeles, California 90033, United States
Shands Burn Center, University of Florida, Gainsville, Florida 32610, United States
Joseph Still Burn Center, Augusta, Georgia 30909, United States
UI Burn Treatment center, Iowa City, Iowa 52242, United States
Cornell Medical Center, New York, New York 10065, United States
Paul Silverstein Burn center, Oklahoma city, Oklahoma 73112, United States
St Christopher's Hospital, Philadelphia, Pennsylvania 19134, United States
Southwestern Regional Burn Center, Parkland Hospital, Dallas, Texas 75235, United States
Department of Surgery, Seattle, Washington 98104, United States
The Burn Center, Washington Hospital Center, WashingtonDC, Washington 20010, United States
Additional Information
Starting date: August 2008
Last updated: October 11, 2010
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