A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology

This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days in total for the entire investigation, thus approximately 70 days. The subjects will test the non-CE marked test product and the comparator product in randomized order.

People with intestinal stomas have, despite development of better stoma products, problems with leakage induced peristomal skin complications which influence quality of life negatively. In fact, the primary cause of peristomal skin complication development is due to leakage of ostomy effluents under the adhesive barrier. Some of the common clinical signs of peristomal skin complications include pain, itching, burning, discoloration, bleeding, and wounds . To overcome this, Coloplast A/S has developed a new baseplate which is comprised of a protective layer.

This investigation is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation, with two test periods. In total 82 subjects will be included and randomised, and each subject will have at least three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days; thus approximately 70 days. The subjects will test the non-CE marked investigational product and the comparator product in a randomised order.

Before the test periods, the subjects are invited for a screening visit (V0). Subjects will be consented prior to any study procedures. Once consented, during their participation, the subjects will complete three study visits (V1, V2 and V3). The visits can be at the Principal Investigators clinic or in the subject's home. In rare cases (i.e. global pandemic), visits can be done remotely via video conference. In addition, the Principal Investigator, or designee, will call the subjects four times during the course of the investigation to inquire if the subject has had any issues or concerns.

During the test visits the subject will complete a quality of life questionnaire and discuss/record any adverse events or device deficiencies. The subject will also be asked about the use and handling of the product, and their preference.

At every baseplate change the subjects will be asked to take photos of their stoma/peristomal skin and the backside (adhesive side) of the used product. The photos will be taken with a smartphone using the Coloplast Clinical Trial App. The subject will also be asked to complete a questionnaire about their peristomal skin condition.

Coloplast will provide both the investigational product and the comparator product for all subjects.

If a subject experiences a problem with the investigational product during the investigation, he/she should contact the investigator for advice. Subjects that cannot complete a test period with the test product may choose to use their own product (i.e., SenSura® Mio) for the remainder of the test period. However, this must be documented by the Principal Investigator.

The duration of the test periods (35 -1/+3 days) and number of visits should be adequate to assess data on the skin condition of the subjects. The investigational products are tested for 35 -1/+3 days in each study period to ensure that the skin will have time to adjust to new conditions, reach a steady state, and for the subjects to test the product for an adequate number of days to give a thorough evaluation of the products.

To account for a possible carry-over effect, the steady state period of the treatment period begins after two weeks of product use. It is anticipated that the skin will have adapted to the new product after two weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Has given written consent to participate by signing the Informed Consent Signature Form
2. Is at least 18 years of age and have full legal capacity
3. Has an ileostomy or colostomy with consistent liquid fecal output (6-7 Bristol scale.
4. Is currently using a SenSura® Mio flat product with open bag.
5. Has had the ostomy for at least 90 days.
6. Can use an ostomy product with a max cut size of 45 mm (1-piece) or 38 mm (2-piece).
7. Has experienced leakage\*\* under the baseplate at least three times within the last fourteen days.

   \*\*Leakage defined as output/seeping under the baseplate (see appendix 7)
8. Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last fourteen days. \*\*

   \*\* Proper training of the PI and nurses in how to ask the subject about these symptoms is essential.
9. Is able to handle the electronic diary (questionnaire/photo) themselves. If needed, a trained spouse or caretaker is allowed to assist.
10. Is able to handle (apply, remove, cut, etc.) the product themselves.
11. Understands that any barrier products (film, cream, spray, wipes etc.) are not permissible during the investigation, and is willing to not use these accessories during the investigation.
12. Is willing and suitable (determined by the Principal Investigator or designee) to use a flat custom cut one-piece open or two-piece open product during the investigation.
13. Is willing to change the product (1-piece) or baseplate (2-piece) at least every fourth days.

Exclusion Criteria:

1. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.

   - low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
2. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.

   * Low dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed.
   * Other systemic steroid treatment (e.g., injection or tablet) are not allowed.
3. Is breastfeeding.
4. Is pregnant based on urine pregnancy test.
5. Has known hypersensitivity towards any of the products used in the investigation.