Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers | Completed
Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Leg Ulcers
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Device : Aquacel® Ag, Device : Mepilex® Border Ag

Study Arm Groups : Aquacel® Ag, Mepilex® Border Ag

Intervention Type
See Interventions above
Primary Outcome Measures
  • Microbial load reduction; Days 1 and 14
Secondary Outcome Measures
  • 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
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
18 Years - N/A
Who Can Participate
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - 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 Criteria:
  • - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Dept of Child Health, UHW
South Glamorgan
CF14 4XN
Arrowe Park Hospital
CH49 5PE
The Willows Centre for Health Care
M5 2JR
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
ConvaTec Inc.
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Jan 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

23 Aug 2011

Last Updated

29 Jul 2013