Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

Coloplast

Status: Completed

Conditions: Stoma - Ileostomy

Treatments: Device: Coloplast Test product Z; Device: Coloplast Test product Y

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957475

CP240

Details and patient eligibility

About

The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written informed consent and signed letter of authority.
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ileostomy for at least 3 months.
4. Have used a 2-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have an ileostomy with a diameter of 30 mm or less.
7. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

Exclusion criteria

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Participating in other interventional clinical investigations or have previously participated in this investigation.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

First Coloplast Test product Z; then Coloplast Test product Y

Experimental group

Description:

The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y

Treatment:

Device: Coloplast Test product Y

Device: Coloplast Test product Z

First Coloplast Test product Y, Then Coloplast Test product Z

Experimental group

Description:

The subjects first test test product Y and after cross-over test product Z

Treatment:

Device: Coloplast Test product Y

Device: Coloplast Test product Z