Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: Coloplast Test 1; Device: Coloplast Test 3; Device: Coloplast Test 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957397

CP230

Details and patient eligibility

About

To investigate the performance and safety of the three 2-piece convex ostomy appliances

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects interested in participating in the clinical investigation must comply with the following criteria:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months.
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33mm or less
6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion criteria

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)

2. Are pregnant* or breastfeeding.

3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.

4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.

5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).

6. Known hypersensitivity toward 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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26 participants in 2 patient groups

Coloplast Test 1

Experimental group

Description:

The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2 Finally the all subject test Coloplast Test 3

Treatment:

Device: Coloplast Test 2

Device: Coloplast Test 3

Device: Coloplast Test 1

Coloplast Test 2

Experimental group

Description:

The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1 Finally the all subject test Coloplast Test 3

Treatment:

Device: Coloplast Test 2

Device: Coloplast Test 3

Device: Coloplast Test 1