A Clinical Investigation of New Ostomy Appliances

Not Applicable

Completed

• Conditions: Leakage

• Registration Number: NCT01523756
• Lead Sponsor: Coloplast A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-30
• Study Start: 2012-02
• Study First Posted: 2012-02-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-11-21
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Results First Posted: 2014-03-10
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Leakage Under the Base Plate Using a 24-point Scale	Each product will be tested 2 weeks	Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark