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

Second Degree Burn Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742183
• Other study ID #: PUMA 415
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: November 6, 2017
• Start date: August 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2017
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Second Degree Burn

Intervention

Device:
• Mepilex
Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
• Silvadene
Silvadene - dressing changes every day, more frequently if needed

Locations

Country	Name	City	State
United States	Joseph Still Burn Center	Augusta	Georgia
United States	Southwestern Regional Burn Center, Parkland Hospital	Dallas	Texas
United States	Shands Burn Center, University of Florida	Gainesville	Florida
United States	UI Burn Treatment center	Iowa City	Iowa
United States	LA County Hospital & USC Medical Center	Los Angeles	California
United States	Cornell Medical Center	New York	New York
United States	Paul Silverstein Burn center	Oklahoma City	Oklahoma
United States	St Christopher's Hospital	Philadelphia	Pennsylvania
United States	Department of Surgery	Seattle	Washington
United States	The Burn Center, Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Costs of Using the Interventions (Direct and Indirect)	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 (?costs/ ?effects). 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	August 2008-August 2009