Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide 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
No text entered.


  More Information
  Hide More Information

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



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)