Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances

Inclusion Criteria:

1. Have given written informed consent and signed letter of authority.
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ileostomy for at least 3 months.
4. Have used a 2-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have an ileostomy with a diameter of 30 mm or less.
7. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Participating in other interventional clinical investigations or have previously participated in this investigation.