CompletedNot Applicable

Investigation of a New Stoma Product for People With a Stoma

Norway79 participantsStarted 2020-01-22

Plain-language summary

The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Has given informed consent to participate by signing the informed consent signature form.
✓. Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale)
✓. Currently using a flat product
✓. Be at least 18 years of age and have full legal capacity
✓. Have had their stoma for at least three months (90 days)
✓. Can use a product with a max cut size of 40 mm
✓. Has experienced leakage\* under the baseplate at least three times within the last 14 days. \*leakage defined as output seeping under the baseplate (Appendix 6 - Classification of leakage)
✓. Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below

Exclusion criteria

✕. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
✕. Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray.
✕. Is breastfeeding
✕. Is pregnant (based on pregnancy test -urine)
✕. Has known hypersensitivity towards any of the products used in the investigation

What they're measuring

Max Itching Within a Week at Steady State

Timeframe: Within a week at steady state

Trial details

NCT IDNCT04101318

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-17

Results submitted2021-11-08

View on ClinicalTrials.gov More Peristomal Skin Complication trials