Clinical trial NCT00742183: Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Second Degree Burn
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Compare the Costs of Using the Interventions (Direct and Indirect)
timeFrame: August 2008-August 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA County Hospital & USC Medical Center
state: California
city: Washington
country: United States
facility: The Burn Center, Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands Burn Center, University of Florida
state: Florida
city: Augusta
country: United States
facility: Joseph Still Burn Center
state: Georgia
city: Iowa City
country: United States
facility: UI Burn Treatment center
state: Iowa
city: New York
country: United States
facility: Cornell Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Paul Silverstein Burn center
state: Oklahoma
city: Philadelphia
country: United States
facility: St Christopher's Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Southwestern Regional Burn Center, Parkland Hospital
state: Texas
city: Seattle
country: United States
facility: Department of Surgery
state: Washington
Study officials:
affiliation: Paul Silverstein Burn Center
name: Paul Silverstein
role: PRINCIPAL_INVESTIGATOR
References: