The Influence of Baseplate Adhesive on the Degree of Leakage

Coloplast

Status: Completed

Conditions: Colostomy Stoma; Ileostomy Stoma

Treatments: Device: Coloplast Test B; Device: Standard product; Device: Coloplast Test A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01995357

CP244

Details and patient eligibility

About

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written informed consent and signed letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy/colostomy for at least 3 months
4. Have a stoma with a diameter between 15 and 36 mm
5. Be able to handle the products themselves
6. Be able to use a custom cut product
7. Normally experience faeces under the base plate at least 3 times during 2 weeks
8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
9. Be willing to test the test products without using paste and/or ring
10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
11. Be suitable for participation in the investigation
12. Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion criteria

1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Use irrigation during the investigation (flush the intestines with water)
6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
7. Have a loop stoma
8. Have known hypersensitivity towards any of the test products (including adhesive remover)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 6 patient groups

First Coloplast Teast A; then Coloplast Test B

Experimental group

Description:

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B

Treatment:

Device: Coloplast Test B

Device: Standard product

Device: Coloplast Test A

First Coloplast Test A; Then Standard product

Experimental group

Description:

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B

Treatment:

Device: Coloplast Test B

Device: Standard product

Device: Coloplast Test A

First Coloplast Test B; Then Colopast Test A

Experimental group

Description:

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A

Treatment:

Device: Coloplast Test B

Device: Standard product

Device: Coloplast Test A

First Coloplast Test B; Then Standard product

Experimental group

Description:

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A

Treatment:

Device: Coloplast Test B

Device: Standard product

Device: Coloplast Test A

First Standard product; Then Coloplast Test A

Experimental group

Description:

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B

Treatment:

Device: Coloplast Test B

Device: Standard product

Device: Coloplast Test A

First Standard Product, Then Coloplast test B

Experimental group

Description:

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A

Treatment:

Device: Coloplast Test B

Device: Standard product

Device: Coloplast Test A