The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Quality of Life (Scale 0(Worst)-100(Best)) [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Real life assessment of SenSura
Other Name: SenSura
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626821
|United States, Missouri|
|Kansas City, Missouri, United States, 64119|
|Principal Investigator:||Birgitte D Andersen, RN||Herlev Hospital, Dep of colorectal surgery|