Investigation of a New 1-piece Convex Ostomy Product

Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Inclusion Criteria:

• Are at least 18 years of age and have full legal capacity.
• Have had an ileostomy/colostomy for more than 3 months
• Have used a 1-piece flat ostomy product for the last 1 month
• Has given written Informed Consent and signed the letter of authority
• Have an ileostomy or colostomy with a diameter of 33 mm or less
• Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
• Are evaluated to be suitable for a soft convex product
• If having a colostomy: changes their product on average 2 times pr. 24h or more
• Currently uses a bag of size medi/midi or maxi

Exclusion Criteria:

• Have a loop ostomy (also called double-barrel or ostomy with two outlets).
• Are pregnant or breastfeeding
• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
• Known hypersensitivity toward any of the test products
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestine with water)
• Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
• If subject has a colostomy: empties the bag