The Influence of Adhesive Wafer Design on Fit to the Body (NCT02176954) | Clinical Trial Compass
CompletedNot Applicable
The Influence of Adhesive Wafer Design on Fit to the Body
Netherlands, United Kingdom40 participantsStarted 2014-07
Plain-language summary
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
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:
To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:
* Have given written informed consent and signed letter of Authority
* Be at least 18 years of age and have full legal capacity
* Have had their ileostomy or colostomy for at least 3 months
* Have a stoma with a diameter between 15 and 43 mm
* Be able to handle the product themselves
* Be able to use a custom cut product
* Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
* Currently using a 1-piece flat product or a 1-piece soft convex product
* Be willing to test products with open bag size maxi
* Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
* Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
* Be suitable for participating in the investigation
* Be willing to take/have taken pictures of the stoma before, during and after application of product
Exclusion Criteria:
Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
* Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
* Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Are participating in other interventional clinical…