Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
13
Princess of Wales Hospital
Bridgend, Mid Glam, United Kingdom
Wrexham Maelor Hospital
Wrexham, North Wales, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Manor Hospital
Walsall, West Midlands, United Kingdom
Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions
The primary objective of this study is to evaluate the safety of the enhanced one piece drainable pouch with a mouldable skin barrier wafer and two alternate adhesives in subjects with an ileostomy.
Time frame: 59 days
Performance
Performance will be evaluated by comparing the following categories to the subject's usual pouching system Wear time Adhesion Ease of Use Mouldability Comfort and flexibility Security Skin protection Wafer seal integrity Undermining Filter performance Accessory usage At the end of the study a comparative assessment of the subject's usual pouching system and the study pouch will be made.
Time frame: 59 days
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Homerton University Hospital
London, United Kingdom