Evaluating the Cost-Effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene® in the Treatment of Partial Thickness Burns.
Information source: Molnlycke Health Care AB
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Second Degree Burn
Intervention: Mepilex (Device); Silvadene (Device)
Phase: Phase 4
Status: Recruiting
Sponsored by: Molnlycke Health Care AB
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.
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: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life)
Eligibility
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
LA County Hospital & USC Medical Center, Los Angeles, California 90033, United States; Recruiting
Javona Wright, Phone: 323-226-2615, Email: jwright@surgery.usc.edu
Warren Garner, M.D, Principal Investigator
Shands Burn Center, University of Florida, Gainsville, Florida 32610, United States; Recruiting
Tera Thigpin, Phone: 352-265-0111, Email: tera.thigpin@surgery.ufl.edu
David Mozingo, MD, Principal Investigator
Joseph Still Burn Center, Augusta, Georgia 30909, United States; Recruiting
Joan Wilson, Phone: 706-364-2966, Email: joan.wilson@jmsburncenters.com
Robert F Mullins, M.D, Principal Investigator
UI Burn Treatment center, Iowa City, Iowa 52242, United States; Recruiting
Janelle Born, Email: Janelle-born@uiowa.edu
Barbara Latenser, M.D, Principal Investigator
Cornell Medical Center, New York, New York 10065, United States; Recruiting
Angela Rabbits, Phone: 212-746-5410, Email: Anr2002@med.cornell.edu
Joseph Turkowski, M.D, Principal Investigator
Paul Silverstein Burn center, Oklahoma city, Oklahoma 73112, United States; Recruiting
Garret Wood, Phone: 405-951-2714, Email: Garret.Wood@Integris-Health.com
Herbert Meites, M.D, Principal Investigator
St Christopher's Hospital, Philadelphia, Pennsylvania 19134, United States; Recruiting
Rose Waltz, Phone: 215-427-5191, Email: Rose.Waltz@tenethealth.com;
Paul Glat, M.D, Principal Investigator
Southwestern Regional Burn Center, Parkland Hospital, Dallas, Texas 75235, United States; Recruiting
Agnes Burris, Phone: 214-648-3521, Email: Agnes.Burris@UTSouthwestern.edu
Gary F Purdue, MD, Principal Investigator
Department of Surgery, Seattle, Washington 98104, United States; Recruiting
Shari Honari, Phone: 206-744-3587, Email: shonari@u.washington.edu
David M Heimbach, M.D, Principal Investigator
The Burn Center, Washington Hospital Center, WashingtonDC, Washington 20010, United States; Recruiting
Anna Pavlovich, Phone: 202-877-7347, Email: Anna.R.Pavlovich@medstar.net
Marion MD Jordan, Principal Investigator
Additional Information
Starting date: August 2008
Last updated: March 5, 2009
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