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

Study Overview
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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.

Official Title
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An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Conditions
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Leg Ulcer

Intervention / Treatment
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* Device: AQUACEL®
* Device: AQUACEL® Extra™


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AQUACEL®<br>A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC). | Device: AQUACEL®<br>* Dressing to be changed as clinically needed or at least every seven days.<br>|
| Active Comparator: AQUACEL® Extra™<br>A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns. | Device: AQUACEL® Extra™<br>* Dressing to be changed as clinically needed or at least every seven days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wear Time | frequency of dressing changes | 4 weeks | 
| Wear Time | Reason for dressing changes | 4 weeks | 
| % of dressings achieving a 7 day wear time |  | 4 weeks | 
| Time to achieve a 7 day wear time |  | 4 weeks | 
| Condition of the peri-ulcer skin | Improvement from baseline in the condition of the peri-ulcer skin | 4 weeks |