Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

Not Applicable

Completed

Interventions: Device: Coloplast Test Product
Device: Comparator (Hollister)

Brief Summary: The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.

Recruitment & Eligibility

Inclusion Criteria

Have given written informed consent and in DK: signed a 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
Able to use a baseplate size 15 to 40 mm
Be able to handle the product themselves
Normally experience faeces under the baseplate at least 3 times during 2 weeks
Currently using a 2-piece flat product with mechanical coupling
Willing to test both the Coloplast test product and the comparator product
Willing to use an open bag size maxi during the investigation
Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
Willing to use at least 1 baseplate every 3rd day during the investigation
Is able to use a custom cut product
Be suitable for participating in the investigation

Exclusion Criteria

Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
Are pregnant or breastfeeding
Are participating in other interventional clinical investigations or have previously participated in this investigation
Use irrigation during the investigation (flush the intestines with water)
Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
Have a loop ostomy
Have known hypersensitivity towards any of the products used in the investigation

Arm && Interventions

Group	Intervention	Description
Comparator then Coloplast Test Product	Coloplast Test Product	The subject first tests the Comparator and then tests the Coloplast Test Product.
Comparator then Coloplast Test Product	Comparator (Hollister)	The subject first tests the Comparator and then tests the Coloplast Test Product.
Coloplast Test Product then Comparator	Coloplast Test Product	The subject first tests the Coloplast Test Product and then tests the Comparator
Coloplast Test Product then Comparator	Comparator (Hollister)	The subject first tests the Coloplast Test Product and then tests the Comparator

Primary Outcome Measures

Name	Time	Method
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".	21 +/- 3 days	Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".

Secondary Outcome Measures

Name	Time	Method

Locations (5): Sykepleierklinikken A/S, Larvik
🇳🇴
Larvik, Norway
SIEWA Coloplast Homecare
🇩🇪
Hamburg, Germany
Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie
🇩🇪
Berlin, Germany
Trial Form Support ApS (TFS)
🇩🇰
Soeborg, Denmark
QPS Netherlands
🇳🇱
Groningen, Netherlands