Clinical Trial: Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers

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

Official Title: A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.

Brief Summary: The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to manage bioburden in leg ulcers over a two week study period.

Detailed Summary:
Sponsor: ConvaTec Inc.

Current Primary Outcome: Microbial load reduction [ Time Frame: Days 1 and 14 ]

The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • clinical evolution of the wound (presence of each of the selected clinical signs) [ Time Frame: Days 1, 3, 7, 14 ]
    Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour
  • Occurrence of adverse events [ Time Frame: Day 1-14 ]


Original Secondary Outcome: Same as current

Information By: ConvaTec Inc.

Dates:
Date Received: August 23, 2011
Date Started: August 2011
Date Completion:
Last Updated: July 29, 2013
Last Verified: July 2013