Status:
COMPLETED
Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Second Degree Burn
Eligibility:
All Genders
5+ years
Phase:
NA
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%...
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 patien...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00742183
Start Date
August 1 2008
End Date
November 1 2009
Last Update
December 8 2017
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
LA County Hospital & USC Medical Center
Los Angeles, California, United States, 90033
2
The Burn Center, Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Shands Burn Center, University of Florida
Gainesville, Florida, United States, 32610
4
Joseph Still Burn Center
Augusta, Georgia, United States, 30909