A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: Coloplast Test D; Device: Coloplast Test C; Device: Coloplast Test A; Device: Own product; Device: Coloplast Test B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02064231

CP222

Details and patient eligibility

About

To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Had given written informed consent
2. Was at least 18 years of age
3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
4. Had an ileostomy with a diameter between 15-45 mm
5. Have had an ileostomy for at least 3 months
6. Currently used a 2-piece flat appliance

Exclusion criteria

1. Used irrigation during the investigation (flush stoma with water)
2. Currently received or had within the past 2 months received radio- and/or chemotherapy.
3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
4. Was pregnant or breast feeding
5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
6. Had a baseplate wear time of more than three days
7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Coloplast Test A, Coloplast Test B, Own product

Experimental group

Description:

The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days

Treatment:

Device: Coloplast Test A

Device: Own product

Device: Coloplast Test B

Coloplast Test C , Coloplast Test D, Own product

Experimental group

Description:

The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days

Treatment:

Device: Coloplast Test D

Device: Coloplast Test C

Device: Own product