The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
183
Coloplast Test product 1 is a newly developed 1-piece ostomy appliance
Coloplast Test product 2 is a newly developed 1-piece ostomy appliance
SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.
Holtedam 3
Humlebæk, Denmark
QPS Nederlands
Groningen, Netherlands
Sykepleierklinikken
Larvik, Norway
Synexus Limited
Chorley, Lancashire, United Kingdom
Leakage
The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Time frame: 14 +- 1 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.