Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

Not Applicable

Completed

Brief Summary: The aim of the investigation was to investigate the performance and safety of a new ostomy product.

Recruitment & Eligibility

Inclusion Criteria

Are at least 18 years of age and have full legal capacity.
Has had an ileostomy for at least 3 months.
Has used a convex ostomy product for the last month.
Has given signed informed consent.
Has experienced seeping under the baseplate at least three times during the last two weeks.
Currently using a SenSura Convex product with midi, maxi or magnum bags.
Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion Criteria

Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
Are pregnant or breastfeeding.
Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
Are currently participating in another clinical intervention study or have previously participated in this one.
Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
Has known hypersensitivity toward the test product.

Arm && Interventions

Group	Intervention	Description
First SenSura Convex Light	Coloplast test product	The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product
First Coloplast test product	SenSura Convex Light	The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light
First Coloplast test product	Coloplast test product	The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light
First SenSura Convex Light	SenSura Convex Light	The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	28 +/- 3 days	The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).

Secondary Outcome Measures

Name	Time	Method

Locations (28): Hopital de Haut Levêque
🇫🇷
Pessac cedex, France
Pro-samed Santitätshaus
🇩🇪
Berlin, Germany
SIEWA Coloplast homecare
🇩🇪
Leinfelden-echterdingen, Germany
Sanitätshaus Fürst GmbH
🇩🇪
Passau, Germany
Alippi GmbH
🇩🇪
Zwickau, Germany
CHRU La Milétrie
🇫🇷
Poitiers Cedex, France
BB medica medizinisches
🇩🇪
Aachen, Germany
Sanitäts- und gesundheitshaus Carqueville GmbH
🇩🇪
Töppeln, Germany
Hopital du bocage
🇫🇷
Dijon cedex, France
Hopital Cochin
🇫🇷
Paris, France
Hopital Claude Huriez
🇫🇷
Lille cedex, France
Hopital Robert Boulin
🇫🇷
Libourne cedex, France
Hopital Nord
🇫🇷
Marseille, France
Patientenberatung Strack e.K.
🇩🇪
Bad Staffelstein, Germany
SIEWA coloplast Homecare
🇩🇪
Burgdorf, Germany
Sanitätshause reinhold hilscher e.K.
🇩🇪
Augsburg, Germany
SIEWA Coloplast Homecare
🇩🇪
Saulgrub, Germany
TFS
🇩🇰
Søborg, Denmark
Hopital Tenon
🇫🇷
Paris, France
Schürmaier GmbH &Co
🇩🇪
Leipzig, Germany
Pilgrim Hospital
🇬🇧
Boston, United Kingdom
Kettering General hospital
🇬🇧
Northamptonshire, United Kingdom
Addenbrookes
🇬🇧
Cambridge, United Kingdom
Sykpleierklinikken
🇳🇴
Larvik, Norway
Cheltenham General Hospital
🇬🇧
Gloucestershire, United Kingdom
Lincon Country hospital
🇬🇧
Lincoln, United Kingdom
west Suffolk Hospital
🇬🇧
Suffolk, United Kingdom
Charing Cross Hospital
🇬🇧
London, United Kingdom