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

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Medical Conditions
  • Leg Ulcers
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01427491

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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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
University Hospital of Wales
Cardiff
CF14 4XN
Clatterbridge Hospital, Surgical Outpatients
Birkenhead
Wirral
CH49 5PE
Tissue Viability Service, The Willows, Centre for Health Care (#11)
Salford
Salford
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CW-0142-11-U358
Sponsor(s)
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 added to source

23 Aug 2011

Date updated in source

29 Jul 2013