Coloplast DialogueStudy

Phase 4

Completed

• Conditions: Stoma
• Interventions: Device: SenSura

• Registration Number: NCT00626821
• Lead Sponsor: Coloplast A/S

Brief 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-29
• Primary Completion: 2010-04
• Study Completion: 2010-12
• Results First Submitted: 2011-10-06
• Status Verified: 2012-01
• Results First Submitted QC: 2012-02-09
• Last Update Submitted: 2012-02-09
• Results First Posted: 2012-03-12
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3017

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SenSura	-

Primary Outcome Measures

Name	Time	Method
Quality of Life (Scale 0(Worst)-100(Best))	6-8 weeks	The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.

Trial Locations

Locations (1)

Restored Images; 🇺🇸 Kansas City, Missouri, United States