The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available. Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
QPS Netherlands
Groningen, Netherlands
Synexus Thames Valley
Berkshire, United Kingdom
Synexus Midlands
Birmingham, United Kingdom
Synexus Wales
Cardiff, United Kingdom
Fit to body
Subjects will evaluate the fit to body for each product by answering the question "How was the base plates ability to fit the body contours in the area around the stoma?" The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.
Time frame: 14 +/- 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Synexus Scotland
Glasgow, United Kingdom
Cheltenham General Hospital
Gloucestershire, United Kingdom
Synesxus Lancashire
Lancashire, United Kingdom
Synexus Merseyside
Liverpool, United Kingdom
Synexus Manchester
Manchester, United Kingdom
Synexus North East
Northumberland, United Kingdom