Assessment of New Ostomy Devices in Subjects Having an Ileostomy

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: SenSura Mio; Device: Coloplast Ostomy device 1; Device: Coloplast Ostomy device 3; Device: Coloplast Ostomy device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03427203

CP264

Details and patient eligibility

About

The study investigates the performance of three new adhesives with regard to leakage and the skin condition.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written informed consent and in DK: signed a letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Must be able to use custom cut product
5. Can use a product with max cut size 45 mm
6. Self-reported problems with leakage (3 x within 14 days)
7. Get a negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion criteria

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation 4.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP264) protocol.
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Arm 1

Experimental group

Description:

The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3

Treatment:

Device: Coloplast Ostomy device

Device: Coloplast Ostomy device 3

Device: SenSura Mio

Device: Coloplast Ostomy device 1

Arm 2

Experimental group

Description:

The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2

Treatment:

Device: Coloplast Ostomy device

Device: Coloplast Ostomy device 3

Device: SenSura Mio

Device: Coloplast Ostomy device 1