Human Skin Test Model in Colostomists

Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists

The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.

Inclusion Criteria:

1. Have given written informed consent.
2. Be in the age of 45 to 75 years of age both extremes included.
3. Have had a colostomy for at least 1 year.
4. Has a colostomy with a diameter up to (≤) 40 mm.
5. Have mental capacity to understand the study guidelines and questionnaires.
6. Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
7. Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
8. Have a BMI between 20-30 kg/m2.
9. Are willing to comply with investigation procedures.

Exclusion Criteria:

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

2. Received radio- and/or chemotherapy within the last two months.

3. Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.

   on peristomal skin (injections and oral treatment are accepted).

4. Have dermatological problems.

5. Participating in other clinical studies or have previously participated in this test.

6. Be a daily user of a convex base-plate.

7. Are pregnant or breastfeeding.

8. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).