Status:
COMPLETED
A Clinical Investigation of New Ostomy Appliances
Lead Sponsor:
Coloplast A/S
Conditions:
Leakage
Eligibility:
All Genders
18+ years
Phase:
NA
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 fo...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Have had an ileostomy for more than 3 months.
- Have used convex products for the last 1 month.
- Has given written Informed Consent.
- Have an ileostomy with a diameter between 15 and 33 mm.
- Have inward peristomal area
Exclusion
- Have loop ostomy
- Pregnant or breastfeeding.
- Known allergy towards any of the product components or ingredients.
- Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01523756
Start Date
February 1 2012
End Date
April 1 2012
Last Update
March 10 2014
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark, Denmark, 3050