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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01427491
First Posted: September 1, 2011
Last Update Posted: July 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ConvaTec Inc.
  Purpose
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.

Condition Intervention Phase
Leg Ulcers Device: Aquacel® Ag Device: Mepilex® Border Ag Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.

Resource links provided by NLM:


Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Microbial load reduction [ Time Frame: Days 1 and 14 ]
    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) [ Time Frame: Days 1, 3, 7, 14 ]
    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 [ Time Frame: Day 1-14 ]

Enrollment: 18
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aquacel® Ag 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.
Active Comparator: Mepilex® Border 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427491


Locations
United Kingdom
The Willows Centre for Health Care
Weaste, Salford, United Kingdom, M5 2JR
Wound Healing Research Unit, Cardiff University
Cardiff, Wales, United Kingdom, CF14 4XN
Arrowe Park Hospital
Upton, Wirral, United Kingdom, CH49 5PE
Sponsors and Collaborators
ConvaTec Inc.
Investigators
Principal Investigator: Keith Harding Cardiff University
  More Information

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01427491     History of Changes
Other Study ID Numbers: CW-0142-11-U358
First Submitted: August 23, 2011
First Posted: September 1, 2011
Last Update Posted: July 30, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents