Clinical trial NCT01517178: Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
Official title: An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Leakage
Skin Condition
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.

The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.

The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.

Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.

The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.

100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.


Eligibility criteria: Inclusion Criteria:

1. Have given written Informed Consent
2. Is at least 18 years old
3. Has the mental capacity to understand the study guidelines and questionnaires
4. Has had their ileostomy for at least 3 months
5. Has an ileostomy with a diameter between 19-40 mm
6. Is currently using a flat 2-piece product with with mechanical coupling
7. Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
8. Has experienced leakage under the base plate at least once a week over the last 2 weeks

Exclusion Criteria:

1. Is pregnant or breast-feeding
2. Currently receiving or has within the past 2 months received radio- and/or chemotherapy
3. Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
4. Is currently using a convex base plate
5. Participating in other clinical studies or has previously participated in this study

Primary outcomes:
measure: Degree of Output Under the Base Plate (Leakage).
timeFrame: Each test product was assessed for 2 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Sønderjylland i Aabenraa
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Marseille
country: France
facility: Hôpital Nord
city: Nantes cedex 1
country: France
facility: Hôpital Hôtel Dieu de Nantes
city: Paris cedex 10
country: France
facility: Hôpital Lariboisière
city: Poitiers cedex
country: France
facility: CHRU La Milétrie
city: Rennes cedex 9
country: France
facility: Hôpital de Pontchaillou, CHRU de Rennes
city: Passau
country: Germany
facility: Sanitätshaus Fürst GmbH
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital
Study officials:
References: