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
Health Conditions
  • Leg Ulcers
Completed
Recruitment Status
NCT01427491
Primary Trial ID Number
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.
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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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
Interventions
Device; Aquacel® Ag; 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.; [Aquacel® Ag]; Device; Mepilex® Border Ag; 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.; [Mepilex® Border Ag]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
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Scientific Title
A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.
Secondary Trial Identifying Number
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Website
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Study Funded By
ConvaTec Inc.
Funder Type
Sorry, this information is not available
Study Sponsored By
ConvaTec Inc.
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

23 Aug 2011

Last Updated

29 Jul 2013

Date Record Refreshed on UKCTG

31 Jul 2015