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

NCT ID: NCT00742183

Last Updated: 2017-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-11-30

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.

Conditions

Second Degree Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mepilex

Intervention Type: DEVICE

Mepilex Ag - dressing changes every 5-7 days, more frequently if needed

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.

Group Type: ACTIVE_COMPARATOR

Silvadene

Intervention Type: DEVICE

Silvadene - dressing changes every day, more frequently if needed

Interventions

Mepilex

Mepilex Ag - dressing changes every 5-7 days, more frequently if needed

Intervention Type: DEVICE

Silvadene

Silvadene - dressing changes every day, more frequently if needed

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Silverstein

Role: PRINCIPAL_INVESTIGATOR

Paul Silverstein Burn Center

Locations

LA County Hospital & USC Medical Center

Los Angeles, California, United States

The Burn Center, Washington Hospital Center

Washington D.C., District of Columbia, United States

Shands Burn Center, University of Florida

Gainesville, Florida, United States

Joseph Still Burn Center

Augusta, Georgia, United States

UI Burn Treatment center

Iowa City, Iowa, 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

Southwestern Regional Burn Center, Parkland Hospital

Dallas, Texas, United States

Department of Surgery

Seattle, Washington, United States

Countries

United States

Other Identifiers

PUMA 415

Identifier Type: -

Identifier Source: org_study_id