A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: Ostomy device 2; Device: Ostomy device 3; Device: Ostomy device 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03154944

CP275

Details and patient eligibility

About

This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.

Enrollment: 38 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. Have an ileostomy with a diameter between 10 and 55 mm
5. Be able to handle the Clinical App. and product themselves
6. Must be able to use custom cut product
7. Minimum change of product every second day
8. If current product is SenSura Mio - Be willing to use Maxi bag during investigation
9. Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study.
10. 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
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: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

Ostomy device 1

Experimental group

Description:

In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film

Treatment:

Device: Ostomy device 1

Ostomy device 2

Experimental group

Description:

In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film

Treatment:

Device: Ostomy device 2

Ostomy device 3

Experimental group

Description:

In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film

Treatment:

Device: Ostomy device 3