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

Information source: Molnlycke Health Care AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Second Degree Burn

Intervention: Mepilex (Device); Silvadene (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Molnlycke Health Care AB


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Compare the Costs of Using the Interventions (Direct and Indirect)


Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- Pregnancy

- Previously randomised to this investigation

Locations and Contacts

LA County Hospital & USC Medical Center, Los Angeles, California 90033, United States

Shands Burn Center, University of Florida, Gainsville, Florida 32610, United States

Joseph Still Burn Center, Augusta, Georgia 30909, United States

UI Burn Treatment center, Iowa City, Iowa 52242, United States

Cornell Medical Center, New York, New York 10065, United States

Paul Silverstein Burn center, Oklahoma city, Oklahoma 73112, United States

St Christopher's Hospital, Philadelphia, Pennsylvania 19134, United States

Southwestern Regional Burn Center, Parkland Hospital, Dallas, Texas 75235, United States

Department of Surgery, Seattle, Washington 98104, United States

The Burn Center, Washington Hospital Center, WashingtonDC, Washington 20010, United States

Additional Information

Starting date: August 2008
Last updated: October 11, 2010

Page last updated: August 23, 2015

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