Study to Evaluate the Performance of AQUACEL® Extra™ in Venous 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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-09-30

Brief Summary

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Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.

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Detailed Description

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Conditions

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Leg Ulcer

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®

A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).

Group Type ACTIVE_COMPARATOR

AQUACEL®

Intervention Type DEVICE

Dressing to be changed as clinically needed or at least every seven days.

AQUACEL® Extra™

A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.

Group Type ACTIVE_COMPARATOR

AQUACEL® Extra™

Intervention Type DEVICE

Dressing to be changed as clinically needed or at least every seven days.

Interventions

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AQUACEL®

Dressing to be changed as clinically needed or at least every seven days.

Intervention Type DEVICE

AQUACEL® Extra™

Dressing to be changed as clinically needed or at least every seven days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects over 18 years, willing and able to provide written informed consent.
* Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
* Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1) with duration less than 24 months
* Subjects whose ulcer is no smaller than 2cms in any one direction
* Subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width)
* Subjects' whose index leg ulcer has a moderate to heavy level of exudate.
* Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control
* Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.

Exclusion Criteria

* Subjects with a history of skin sensitivity to any of the components of the study dressings (AQUACEL® Extra™, AQUACEL®, \& DuoDERM™ Extra Thin)
* Subjects whose wounds are considered clinically infected at baseline
* Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
* Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
* Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
* Subjects who have participated in a clinical study within the past month.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No