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

A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcers
• Intervention / Treatment: Device: Aquacel® Ag; Device: Mepilex® Border Ag

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Salford
    • Weaste, Salford, United Kingdom, M5 2JR
      • The Willows Centre for Health Care
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XN
      • Wound Healing Research Unit, Cardiff University
  • Wirral
    • Upton, Wirral, United Kingdom, CH49 5PE
      • Arrowe Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Days 1 and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Days 1, 3, 7, 14
Occurrence of adverse events		Day 1-14

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Keith Harding, Cardiff University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: August 23, 2011
• First Submitted That Met QC Criteria: August 31, 2011
• First Posted (Estimate): September 1, 2011

Study Record Updates

• Last Update Posted (Estimate): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: CW-0142-11-U358

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No