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

Not Applicable

Completed

Conditions: Ileostomy - Stoma

Interventions: Device: Coloplast Test 1
Device: Coloplast Test 2
Device: Coloplast Test 3

Registration Number: NCT01957397

Lead Sponsor: Coloplast A/S

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

Inclusion Criteria

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

Are at least 18 years of age and have full legal capacity
Have had an ileostomy for at least 3 months.
Have used a convex ostomy appliance for the last month
Have given written informed consent
Have an ileostomy with a diameter of 33mm or less
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:

Have a loop ostomy (also called double-barrel or ostomy with two outlets)
Are pregnant* or breastfeeding.
Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
Known hypersensitivity toward any of the test products

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coloplast Test 1	Coloplast Test 3	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
Coloplast Test 2	Coloplast Test 3	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
Coloplast Test 2	Coloplast Test 1	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
Coloplast Test 1	Coloplast Test 1	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
Coloplast Test 1	Coloplast Test 2	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
Coloplast Test 2	Coloplast Test 2	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

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	14 days	The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)

Secondary Outcome Measures