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

Phase 3

Completed

• Conditions: Leg Ulcers
• Interventions: Device: Aquacel® Ag; Device: Mepilex® Border Ag

• Registration Number: NCT01427491
• Lead Sponsor: ConvaTec Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aquacel® Ag	Aquacel® Ag	-
Mepilex® Border Ag	Mepilex® Border Ag	-

Primary Outcome Measures

Name	Time	Method
Microbial load reduction	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

Name	Time	Method
clinical evolution of the wound (presence of each of the selected clinical signs)	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	Day 1-14

Trial Locations

Locations (3)

Arrowe Park Hospital; 🇬🇧 Upton, Wirral, United Kingdom

The Willows Centre for Health Care; 🇬🇧 Weaste, Salford, United Kingdom

Wound Healing Research Unit, Cardiff University; 🇬🇧 Cardiff, Wales, United Kingdom