The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
Trial Form Support ApS (TFS)
Soeborg, Denmark
Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie
Berlin, Germany
SIEWA Coloplast Homecare
Hamburg, Germany
QPS Netherlands
Groningen, Netherlands
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".
Time frame: 21 +/- 3 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sykepleierklinikken A/S, Larvik
Larvik, Norway