Clinical Trial: Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Brief Summary: Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.

Detailed Summary:
Sponsor: ConvaTec Inc.

Current Primary Outcome:

• Wear Time [ Time Frame: 4 weeks ]
  frequency of dressing changes
• Wear Time [ Time Frame: 4 weeks ]
  Reason for dressing changes
• % of dressings achieving a 7 day wear time [ Time Frame: 4 weeks ]
• Time to achieve a 7 day wear time [ Time Frame: 4 weeks ]
• Condition of the peri-ulcer skin [ Time Frame: 4 weeks ]
  Improvement from baseline in the condition of the peri-ulcer skin

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ConvaTec Inc.

Dates:
Date Received: May 2, 2012
Date Started: May 2012
Date Completion:
Last Updated: July 29, 2013
Last Verified: July 2013