Status:
COMPLETED
Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers
Lead Sponsor:
ConvaTec Inc.
Conditions:
Leg Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Known skin sensitivity to any component of the products being tested
- Subjects who have had current local or systemic antibiotics and/or topical antimicrobials applied in the week prior to inclusion
- Depth of ulcer classified as superficial (not involving dermis) or deep (exposing muscle and tendon)
- Any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
- Participated in a clinical study within the past 30 days
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01427491
Start Date
August 1 2011
End Date
January 1 2012
Last Update
July 30 2013
Active Locations (3)
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1
The Willows Centre for Health Care
Weaste, Salford, United Kingdom, M5 2JR
2
Wound Healing Research Unit, Cardiff University
Cardiff, Wales, United Kingdom, CF14 4XN
3
Arrowe Park Hospital
Upton, Wirral, United Kingdom, CH49 5PE