Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

To investigate the performance and safety of the three 2-piece convex ostomy appliances

Inclusion Criteria:

Subjects interested in participating in the clinical investigation must comply with the following criteria:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months.
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33mm or less
6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)

2. Are pregnant* or breastfeeding.

3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.

4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.

5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).

6. Known hypersensitivity toward any of the test products

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