The Influence of Adhesive Wafer Design on Fit to the Body

Coloplast

Status: Completed

Conditions: Ostomy - Ileostomy or Colostomy

Treatments: Device: Test B; Device: Comparator; Device: Test A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176954

CP247

Details and patient eligibility

About

The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestines with water)
• Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
• Have a loop stoma
• Have known hypersensitivity towards any of the test products

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 6 patient groups

Test A, Test B, Comparator

Experimental group

Description:

The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator.

Treatment:

Device: Test B

Device: Comparator

Device: Test A

Test A, Comparator, Test B

Experimental group

Description:

The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B.

Treatment:

Device: Test B

Device: Comparator

Device: Test A

Test B, Test A, Comparator

Experimental group

Description:

The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator.

Treatment:

Device: Test B

Device: Comparator

Device: Test A

Test B, Comparator, Test A

Experimental group

Description:

The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B.

Treatment:

Device: Test B

Device: Comparator

Device: Test A

Comparator, Test A, Test B

Experimental group

Description:

The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B

Treatment:

Device: Test B

Device: Comparator

Device: Test A

Comparator, Test B, Test A

Experimental group

Description:

The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A.

Treatment:

Device: Test B

Device: Comparator

Device: Test A