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

This study has been completed.
Sponsor:
Information provided by:
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT00742183
First received: August 19, 2008
Last updated: October 11, 2010
Last verified: October 2010
History of Changes
Results First Received: June 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Second Degree Burn
Interventions: Device: Mepilex
Device: Silvadene

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Investigation period: Sept 2008 - Sept 2009. In- and/or out-patients at ten centers in US were included in this investigation. Subjects included were 5 years and above and suffered from partial thickness burns.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mepilex Ag No text entered.
Silvadene No text entered.

Participant Flow:   Overall Study
    Mepilex Ag     Silvadene  
STARTED     49 [1]   51  
COMPLETED     40     39  
NOT COMPLETED     9     12  
Adverse Event                 2                 2  
Death                 1                 0  
Physician Decision                 0                 2  
Lost to Follow-up                 4                 4  
Required skin-graft                 1                 1  
Withdrawal by Subject                 1                 0  
Lack of Efficacy                 0                 3  
[1] 50 subjects randomised, one of them did not receive any treatment.



  Baseline Characteristics
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Reporting Groups
  Description
Mepilex Ag No text entered.
Silvadene No text entered.
Total Total of all reporting groups

Baseline Measures
    Mepilex Ag     Silvadene     Total  
Number of Participants  
[units: participants]
 		  49     51     100  
Age  
[units: participants]
 		     
<=18 years     4     4     8  
Between 18 and 65 years     41     41     82  
>=65 years     4     6     10  
Age  
[units: years]
Mean ± Standard Deviation 		  37.0  ± 18.1     39.2  ± 18.2     38.4  ± 18.2  
Gender  
[units: participants]
 		     
Female     13     10     23  
Male     36     41     77  
Region of Enrollment  
[units: participants]
 		     
United States     49     51     100  



  Outcome Measures

1.  Primary:   Compare the Costs of Using the Interventions (Direct and Indirect)   [ Time Frame: August 2008-August 2009 ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Viktoria Ahlenius Körner
Organization: Mölnlycke Health Care
phone: +46-31-722 32 46
e-mail: viktoria.ahleniuskorner@molnlycke.com


No publications provided


Responsible Party: Viktoria Körner, Mölnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT00742183     History of Changes
Other Study ID Numbers: PUMA 415
Study First Received: August 19, 2008
Results First Received: June 3, 2010
Last Updated: October 11, 2010
Health Authority: United States: Institutional Review Board