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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Leg Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aquacel® Ag

Group Type ACTIVE_COMPARATOR

Aquacel® Ag

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Mepilex® Border Ag

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No