Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma; Colostomy - Stoma

Treatments: Device: Coloplast Test X; Device: Coloplast Test V

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957462

CP239

Details and patient eligibility

About

The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.

Enrollment: 31 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 ostomy (ileo- or colostomy) for at least 3 months.
4. Have used a 1-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have a ostomy with a diameter of 33 mm or less.

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. Use irrigation during the investigation (flush the stoma with water).
8. 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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31 participants in 2 patient groups

FirstColplast Test V, Then Coloplast Test X

Experimental group

Description:

The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X

Treatment:

Device: Coloplast Test V

Device: Coloplast Test X

First Coloplast Test X, Then Coloplast Test V

Experimental group

Description:

The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V

Treatment:

Device: Coloplast Test V

Device: Coloplast Test X