A Clinical Investigation of New Ostomy Appliances

Leakage Clinical Trial

Official title:

An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523756
• Other study ID #: CP226
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: January 28, 2014
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: January 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: National Ethical Committee for the Capital Region of Denmark
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Leakage

Intervention

Device:
• test product 1: new ostomy base plate with Coloplast as manufacturer
test product 1 is tested first
• test product 2: new ostomy base plate with Coloplast as manufacturer
test product 2 is tested first

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebaek

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leakage Under the Base Plate Using a 24-point Scale	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)	Each product will be tested 2 weeks	No