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

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

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.

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.