Clinical trial NCT01994902: Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
Official title: Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: Inclusion Criteria:

1. Are at least 18 years of age and have full legal capacity.
2. Has had an ileostomy for at least 3 months.
3. Has used a convex ostomy product for the last month.
4. Has given signed informed consent.
5. Has experienced seeping under the baseplate at least three times during the last two weeks.
6. Currently using a SenSura Convex product with midi, maxi or magnum bags.
7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
8. 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:

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

Primary outcomes:
measure: Degree of Leakage
timeFrame: 28 +/- 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: TFS
city: Dijon cedex
country: France
facility: Hopital du bocage
city: Libourne cedex
country: France
facility: Hopital Robert Boulin
city: Lille cedex
country: France
facility: Hopital Claude Huriez
city: Marseille
country: France
facility: Hopital Nord
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Tenon
city: Pessac cedex
country: France
facility: Hopital de Haut Levêque
city: Poitiers Cedex
country: France
facility: CHRU La Milétrie
city: Aachen
country: Germany
facility: BB medica medizinisches
city: Augsburg
country: Germany
facility: Sanitätshause reinhold hilscher e.K.
city: Bad Staffelstein
country: Germany
facility: Patientenberatung Strack e.K.
city: Berlin
country: Germany
facility: Pro-samed Santitätshaus
city: Burgdorf
country: Germany
facility: SIEWA coloplast Homecare
city: Freising
country: Germany
facility: SIEWA Coloplast Homecare
city: Leinfelden-echterdingen
country: Germany
facility: SIEWA Coloplast homecare
city: Leipzig
country: Germany
facility: Schürmaier GmbH &Co
city: Passau
country: Germany
facility: Sanitätshaus Fürst GmbH
city: Saulgrub
country: Germany
facility: SIEWA Coloplast Homecare
city: Töppeln
country: Germany
facility: Sanitäts- und gesundheitshaus Carqueville GmbH
city: Zwickau
country: Germany
facility: Alippi GmbH
city: Larvik
country: Norway
facility: Sykpleierklinikken
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes
city: Gloucestershire
country: United Kingdom
facility: Cheltenham General Hospital
city: Lincoln
country: United Kingdom
facility: Lincon Country hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Northamptonshire
country: United Kingdom
facility: Kettering General hospital
city: Suffolk
country: United Kingdom
facility: west Suffolk Hospital
Study officials:
affiliation: Coloplast A/S
name: Daniel Carter
role: STUDY_DIRECTOR
References: