Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma (NCT03770078) | Clinical Trial Compass
CompletedNot Applicable
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Denmark, Sweden23 participantsStarted 2018-11-12
Plain-language summary
The study investigates the performance of a new adhesive with regard to the skin condition
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:
* Have given written informed consent
* Have an ileostomy or a colostomy with liquid\* output (as their usual output)
* Be at least 18 years of age and have full legal capacity
* Have had their stoma for at least three months
* Be able to use products with max cut size 45 mm
* Have self-reported problems with leakage\*\* (three times within 14 days)
* Handle the Clinical App, test product and comparator product themselves
* Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
* Minimum change of baseplate at least once every 3rd day
* Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
* Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation
Exclusion Criteria:
* Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment\* (e.g. injection or tablets).
* Get a positive result of a pregnancy test for women of childbearing age/fertile (\*\*clarified in section 6.3.2)
* Are breast feeding
* Are participating in other interventi…