Performance Study of Newly Developed Ostomy Products

An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Inclusion Criteria:

1. Have given written informed consent.
2. Be at least 18 years of age and have full legal capacity.
3. Have experienced leakage under the base plate at least once a week over the last two weeks.
4. Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
5. Have a colostomy with a diameter between 20 and 45 mm.
6. Have had their ostomy for at least three months.
7. Currently use a 1-piece flat product with closed bag.
8. Use minimum 1 product per day.
9. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.