Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the bags themselves
4. Have an ileostomy with a diameter between 15 and 55 mm
5. Have had their ileostomy for at least 3 months
6. Currently use a 1-piece flat ostomy appliance with open bag
7. Use minimum 1 product every second day, i.e. maximum 2 days wear time
8. Be suitable for participation in the study and for using a standard adhesive, flat base plate
9. Must be able and willing to use custom cut products
10. Accept to test two 1-piece products within the study period

Exclusion Criteria:

1. Use irrigation during the study period (flush the intestines with water)
2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
3. Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Currently using a ostomy belt
7. Currently using extended wear product
8. Have a loop ileostomy
9. Known hypersensitivity towards any of the test products
10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)