Back to resultsCompare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers
Primary Purpose
Leg Ulcers
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Aquacel® Ag
Mepilex® Border Ag
Sponsored by
About this trial
This is an interventional treatment trial for Leg Ulcers
Eligibility 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
Sites / Locations
- The Willows Centre for Health Care
- Wound Healing Research Unit, Cardiff University
- Arrowe Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aquacel® Ag
Mepilex® Border Ag
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
clinical evolution of the wound (presence of each of the selected clinical signs)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01427491
Brief Title
Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers
Official Title
A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConvaTec Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aquacel® Ag
Arm Type
Active Comparator
Arm Title
Mepilex® Border Ag
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Aquacel® Ag
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mepilex® Border Ag
Intervention Description
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.
Primary Outcome Measure Information:
Title
Microbial load reduction
Description
The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods.
Time Frame
Days 1 and 14
Secondary Outcome Measure Information:
Title
clinical evolution of the wound (presence of each of the selected clinical signs)
Description
Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour
Time Frame
Days 1, 3, 7, 14
Title
Occurrence of adverse events
Time Frame
Day 1-14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Harding
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Willows Centre for Health Care
City
Weaste
State/Province
Salford
ZIP/Postal Code
M5 2JR
Country
United Kingdom
Facility Name
Wound Healing Research Unit, Cardiff University
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Upton
State/Province
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers
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