The Influence of Baseplate Adhesive on the Degree of Leakage

Not Applicable

Completed

Conditions: Ileostomy Stoma
Colostomy Stoma

Interventions: Device: Coloplast Test A
Device: Coloplast Test B
Device: Standard product

Registration Number: NCT01995357

Lead Sponsor: Coloplast A/S

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

Inclusion 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/colostomy for at least 3 months
Have a stoma with a diameter between 15 and 36 mm
Be able to handle the products themselves
Be able to use a custom cut product
Normally experience faeces under the base plate at least 3 times during 2 weeks
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
Be willing to test the test products without using paste and/or ring
Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
Be suitable for participation in the investigation
Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion Criteria

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 local or systemic steroid treatment in the peristomal area
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/investigator representative)
Have a loop stoma
Have known hypersensitivity towards any of the test products (including adhesive remover)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Coloplast Test B; Then Colopast Test A	Coloplast Test A	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
First Coloplast Test B; Then Colopast Test A	Coloplast Test B	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
First Standard Product, Then Coloplast test B	Coloplast Test A	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
First Standard Product, Then Coloplast test B	Standard product	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
First Coloplast Test B; Then Colopast Test A	Standard product	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
First Coloplast Test B; Then Standard product	Coloplast Test B	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
First Coloplast Test B; Then Standard product	Standard product	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
First Standard Product, Then Coloplast test B	Coloplast Test B	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
First Coloplast Teast A; then Coloplast Test B	Coloplast Test B	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
First Coloplast Test A; Then Standard product	Coloplast Test B	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
First Coloplast Test A; Then Standard product	Standard product	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
First Standard product; Then Coloplast Test A	Coloplast Test A	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
First Standard product; Then Coloplast Test A	Coloplast Test B	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
First Coloplast Teast A; then Coloplast Test B	Coloplast Test A	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
First Coloplast Teast A; then Coloplast Test B	Standard product	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
First Coloplast Test A; Then Standard product	Coloplast Test A	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
First Coloplast Test B; Then Standard product	Coloplast Test A	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
First Standard product; Then Coloplast Test A	Standard product	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

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	10 (- 2 days)	The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.

Secondary Outcome Measures