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Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01036438
First received: December 18, 2009
Last updated: September 11, 2014
Last verified: December 2013
Results First Received: September 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Venous Leg Ulcers
Mixed Leg Ulcers
Interventions: Device: Mepilex Ag
Device: Mepilex without Ag

  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
No text entered.

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

Reporting Groups
  Description
Mepilex Product Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
Mepilex Ag Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.

Participant Flow:   Overall Study
    Mepilex Product     Mepilex Ag  
STARTED     101     100  
COMPLETED     91     90  
NOT COMPLETED     10     10  
Adverse Event                 7                 8  
Death                 0                 1  
No effect of study treatment                 3                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mepilex Product Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
Mepilex Ag Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
Total Total of all reporting groups

Baseline Measures
    Mepilex Product     Mepilex Ag     Total  
Number of Participants  
[units: participants]
  101     100     201  
Age  
[units: years]
Mean ± Standard Deviation
  66.4  ± 14.9     68.4  ± 13.4     67.5  ± 14.2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     47     42     89  
>=65 years     54     58     112  
Gender  
[units: participants]
     
Female     54     58     112  
Male     47     42     89  
Region of Enrollment  
[units: participants]
     
France     25     26     51  
Czech Republic     47     47     94  
Netherlands     1     1     2  
Germany     28     26     54  



  Outcome Measures

1.  Primary:   Efficacy Will be Defined as Absolute Wound Size Reduction.   [ Time Frame: 8 weeks ]

2.  Secondary:   Change in Inflammatory Signs   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ann Larkö
Organization: Molnlycke Health Care AB
phone: +46 722 3338
e-mail: ann.larko@molnlycke.com


No publications provided


Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01036438     History of Changes
Other Study ID Numbers: PUMA 416
Study First Received: December 18, 2009
Results First Received: September 4, 2014
Last Updated: September 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)