Safety and Performance of New 1-piece Ostomy Product

Coloplast A/S65 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Stoma Ileostomy

Interventions

Coloplast Adhesive baseplate ADEVICE

Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.

Coloplast Adhesive baseplate BDEVICE

Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance

Coloplast Adhesive baseplate CDEVICE

Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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) -

Locations (1)

Holtedam 3

Humlebæk, Denmark

Outcomes

Primary Outcomes

Degree of Leakage

The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage

Time frame: one week

Data from ClinicalTrials.gov

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