Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01427491
First received: August 23, 2011
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Microbial load reduction [ Time Frame: Days 1 and 14 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01427491     History of Changes
Other Study ID Numbers: CW-0142-11-U358
Study First Received: August 23, 2011
Last Updated: February 8, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013