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.

Study Overview

• Status: Completed
• Conditions: Second Degree Burn
• Intervention / Treatment: Device: Mepilex; Device: Silvadene

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • LA County Hospital & USC Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • The Burn Center, Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Burn Center, University of Florida
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph Still Burn Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • UI Burn Treatment center
  • New York
    • New York, New York, United States, 10065
      • Cornell Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Paul Silverstein Burn center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • St Christopher's Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Southwestern Regional Burn Center, Parkland Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mepilex® Ag; Mepilex® Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment. Mepilex® Ag contains silver sulphate that releases silver ions to inactivate a wide range of wound related pathogens (bacteria and fungi), shown in vitro. By reducing the number of microorganisms, Mepilex® Ag may also reduce odour.	Device: Mepilex; Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
Active Comparator: Silvadene® Cream 1%; Silvadene® Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second-and third-degree burns.	Device: Silvadene; Silvadene - dressing changes every day, more frequently if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (Δcosts/ Δeffects). 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

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Paul Silverstein, Paul Silverstein Burn center

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: August 19, 2008
• First Submitted That Met QC Criteria: August 26, 2008
• First Posted (Estimate): August 27, 2008

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Silver Sulfadiazine
• Other Study ID Numbers: PUMA 415