NCT00626821

Coloplast DialogueStudy

An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,017 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

Detailed description

It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Conditions

• Stoma

Interventions

Type	Name	Description
DEVICE	SenSura	Real life assessment of SenSura

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-04-01
• Completion: 2010-12-01
• First posted: 2008-02-29
• Last updated: 2012-03-12
• Results posted: 2012-03-12

Locations

1 site across 1 country: United States