A Clinical Investigation of New Ostomy Appliances

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

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.

Study Overview

• Status: Completed
• Conditions: Leakage
• Intervention / Treatment: 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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebaek, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test product 1 first; 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	Device: test product 1: new ostomy base plate with Coloplast as manufacturer; test product 1 is tested first
Experimental: test product 2 first; 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	Device: test product 2: new ostomy base plate with Coloplast as manufacturer; test product 2 is tested first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Estimate): March 10, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CP226