A Clinical Investigation of New Ostomy Appliances

Coloplast

Status: Completed

Conditions: Leakage

Treatments: Device: test product 1: new ostomy base plate with Coloplast as manufacturer; Device: test product 2: new ostomy base plate with Coloplast as manufacturer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01523756

CP226

Details and patient eligibility

About

This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years.
2. Have had an ileostomy for more than 3 months.
3. Have used convex products for the last 1 month.
4. Has given written Informed Consent.
5. Have an ileostomy with a diameter between 15 and 33 mm.
6. Have inward peristomal area

Exclusion criteria

1. Have loop ostomy
2. Pregnant or breastfeeding.
3. Known allergy towards any of the product components or ingredients.
4. Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
5. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
6. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)

Trial design

20 participants in 2 patient groups

test product 1 first

Experimental group

Description:

own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1

Treatment:

Device: test product 1: new ostomy base plate with Coloplast as manufacturer

test product 2 first

Experimental group

Description:

own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2

Treatment:

Device: test product 2: new ostomy base plate with Coloplast as manufacturer