A Clinical Investigation of New Ostomy Appliances

• ClinicalTrials.gov Identifier: NCT01523756
• Recruitment Status: Completed
• First Posted: February 1, 2012
• Results First Posted: March 10, 2014
• Last Update Posted: March 10, 2014
• Sponsor: Coloplast A/S
• Information provided by (Responsible Party): Coloplast A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Leakage	Device: test product 1: new ostomy base plate with Coloplast as manufacturer; Device: test product 2: new ostomy base plate with Coloplast as manufacturer	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: February 2012
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Leakage Under the Base Plate Using a 24-point Scale [ Time Frame: 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)

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

Denmark

Coloplast A/S

Humlebaek, Denmark, 3050

Sponsors and Collaborators

Coloplast A/S

More Information

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT01523756
• Other Study ID Numbers: CP226
• First Posted: February 1, 2012
• Results First Posted: March 10, 2014
• Last Update Posted: March 10, 2014
• Last Verified: January 2014