Safety and Performance of New 1-piece Ostomy Product

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Device: Coloplast Adhesive baseplate C; Device: Coloplast Adhesive baseplate B; Device: SenSura 1-Piece; Device: Coloplast Adhesive baseplate A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01800916

CP236

Details and patient eligibility

About

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

Full description

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the bags themselves.
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Currently use a 1-piece flat ostomy appliance with open bag.
7. Use minimum 1 ostomy appliance every second day.
8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
9. Must be able to use a custom cut ostomy appliance.
10. Accept to test three 1-piece ostomy appliances in the investigation.
11. Negative result of a pregnancy test for women of childbearing age (only DK).

Exclusion criteria

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
6. Currently using ostomy belt.
7. Currently using extended wear product.
8. Known hypersensitivity towards any of the test products
9. Suffer from peristomal skin problems that preclude 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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65 participants in 3 patient groups

Treatment sequence 1

Experimental group

Description:

The subjects randomised to Treatment sequence 1 are going to test Coloplast Adhesive baseplate A (A) Coloplast Adhesive baseplate B (B) SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB

Treatment:

Device: Coloplast Adhesive baseplate A

Device: SenSura 1-Piece

Device: Coloplast Adhesive baseplate B

Treatment sequence 2

Experimental group

Description:

The subjects randomised to Treatment sequence 2 are going to test Coloplast Adhesive baseplate B (B) Coloplast Adhesive baseplate C (C) SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB

Treatment:

Device: SenSura 1-Piece

Device: Coloplast Adhesive baseplate B

Device: Coloplast Adhesive baseplate C

Treatment sequence 3

Experimental group

Description:

The subjects randomised to Treatment sequence 3 are going to test Coloplast Adhesive baseplate A (A) Coloplast Adhesive baseplate B (C) SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC

Treatment:

Device: Coloplast Adhesive baseplate A

Device: SenSura 1-Piece

Device: Coloplast Adhesive baseplate C