An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

Not Applicable

Completed

Conditions: Ileostomy

Interventions: Device: Test A
Device: Test B
Device: Baseline

Registration Number: NCT02351817

Lead Sponsor: Coloplast A/S

Brief Summary: The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Have given written informed consent and letter of authority
Be at least 18 years of age and have full legal capacity
Be able to handle the products her/himself
Have an ileostomy with a diameter between 10 and 30 mm
Willing to follow the product change schedule (one change per day)
Have had their ostomy for at least three months
Willing to use 1 piece open ostomy products during the test period
Must be able to use a custom cut product
Have intact skin
Negative result of a pregnancy test for women of childbearing age

Exclusion Criteria

Currently receiving or have within the past 2 months received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
Is pregnant or breastfeeding.
Is participating in other interventional clinical investigations or have previously participated in this investigation
Have a loop ileostomy
Known hypersensitivity towards any of the test products

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Baseline - Test A - Test B	Baseline	Three period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
Baseline - Test A - Test B	Test B	Three period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
Baseline - Test A - Test B	Test A	Three period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
Baseline - Test B - Test A	Baseline	First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
Baseline - Test B - Test A	Test A	First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
Baseline - Test B - Test A	Test B	First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces

Primary Outcome Measures

Name	Time	Method
Product Acceptance	7 days per test period	Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product

Secondary Outcome Measures