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

Convatec

Status and phase: Completed; Phase 3

Conditions: Leg Ulcer

Treatments: Device: AQUACEL®; Device: AQUACEL® Extra™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591434

CW-0209-11-U361

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

AQUACEL®

Active Comparator group

Description:

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

Treatment:

Device: AQUACEL®

AQUACEL® Extra™

Active Comparator group

Description:

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

Treatment:

Device: AQUACEL® Extra™