An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

Coloplast

Status: Completed

Conditions: Ileostomy

Treatments: Device: Test B; Device: Baseline; Device: Test A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02351817

CP256

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Baseline - Test A - Test B

Experimental group

Description:

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

Treatment:

Device: Test B

Device: Baseline

Device: Test A

Baseline - Test B - Test A

Experimental group

Description:

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

Treatment:

Device: Test B

Device: Baseline

Device: Test A