Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers
A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.
1 other identifier
interventional
18
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 30, 2013
July 1, 2013
5 months
August 23, 2011
July 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Microbial load reduction
The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods.
Days 1 and 14
Secondary Outcomes (2)
clinical evolution of the wound (presence of each of the selected clinical signs)
Days 1, 3, 7, 14
Occurrence of adverse events
Day 1-14
Study Arms (2)
Aquacel® Ag
ACTIVE COMPARATORMepilex® Border Ag
ACTIVE COMPARATORInterventions
Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.
Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.
Eligibility Criteria
You may qualify if:
- Aged 18 years or over
- Willing and able to provide written informed consent
- Leg ulcer will be of size ranging between 10 cm2 - 40 cm2 with moderate or heavy exudate
- Leg ulcer will exhibit at least 2 of the 4 following clinical signs: pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour
You may not qualify if:
- Known skin sensitivity to any component of the products being tested
- Depth of ulcer classified as superficial (not involving dermis) or deep (exposing muscle and tendon)
- Participated in a clinical study within the past 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ConvaTec Inc.lead
Study Sites (3)
The Willows Centre for Health Care
Weaste, Salford, M5 2JR, United Kingdom
Wound Healing Research Unit, Cardiff University
Cardiff, Wales, CF14 4XN, United Kingdom
Arrowe Park Hospital
Upton, Wirral, CH49 5PE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith Harding
Cardiff University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2011
First Posted
September 1, 2011
Study Start
August 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 30, 2013
Record last verified: 2013-07