NCT01957384

Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Conditions

• Ileostomy - Stoma

Interventions

Type	Name	Description
DEVICE	Coloplast Test product 1	Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
DEVICE	Coloplast Test product 2	Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
DEVICE	Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)	Standard Care was the subject usual ostomy appliance and had to be one of the following: * Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, * Dansac: Nova 1 \& Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate * Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate * ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate * B. Braun: Flexima Active \& Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2013-10-08
• Last updated: 2014-03-27
• Results posted: 2014-02-14

Locations

1 site across 1 country: Denmark