A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

The test products are non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

Inclusion Criteria:

• Has given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have had a stoma for more than ½ year
• Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
• Willing to change baseplate every second day or less frequent
• Willing to avoid using Concave baseplate during the study.
• Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.

Exclusion Criteria:

• Currently receiving or have within the past 2 months received radio-and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
• Is pregnant or breastfeeding
• Having dermatological problems in the peristomal area (assessed by investigator)