Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Inclusion Criteria:

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Be able to handle the bags themselves or with help from caregiver
• Have an ileostomy with a diameter between 15 and 45 mm
• Have had their ostomy for at least three months
• Currently use a 1-piece flat standard care product with open bag
• Negative result of a pregnancy test for women of childbearing age
• Custom-cut product user
• Be suitable for participation in the investigation

Exclusion Criteria:

• Use irrigation during the study (flush the stoma with water)
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy
• Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
• Are pregnant or breastfeeding
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Max three days wear time
• Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)