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

NCT00742183 | Completed Results

• 1 other identifier: PUMA 415
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Second Degree Burn

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mepilex® Ag

EXPERIMENTAL

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

Silvadene® Cream 1%

ACTIVE COMPARATOR

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

Interventions

Mepilex DEVICE

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

Mepilex® Ag

Silvadene DEVICE

Silvadene - dressing changes every day, more frequently if needed

Silvadene® Cream 1%

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (10)

LA County Hospital & USC Medical Center

Los Angeles, California, 90033, United States

Location

The Burn Center, Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Shands Burn Center, University of Florida

Gainesville, Florida, 32610, United States

Location

Joseph Still Burn Center

Augusta, Georgia, 30909, United States

Location

UI Burn Treatment center

Iowa City, Iowa, 52242, United States

Location

Cornell Medical Center

New York, New York, 10065, United States

Location

Paul Silverstein Burn center

Oklahoma City, Oklahoma, 73112, United States

Location

St Christopher's Hospital

Philadelphia, Pennsylvania, 19134, United States

Location

Southwestern Regional Burn Center, Parkland Hospital

Dallas, Texas, 75235, United States

Location

Department of Surgery

Seattle, Washington, 98104, United States

Location

Results Point of Contact

• Title: Viktoria Ahlenius Körner
• Organization: Mölnlycke Health Care

viktoria.ahleniuskorner@molnlycke.com

+46-31-722 32 46

Study Officials

• Paul Silverstein

  Paul Silverstein Burn Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 27, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 8, 2017
• Results First Posted: November 19, 2010

Record last verified: 2017-11

Locations

US (10)