Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
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
1 other identifier
interventional
33
4 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2011
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedResults Posted
Study results publicly available
March 13, 2015
CompletedMarch 13, 2015
March 1, 2015
1 month
June 24, 2011
March 3, 2015
March 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Degree of Output Under the Base Plate (Leakage).
Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
Each test product was assessed for 2 weeks.
Study Arms (2)
Standard Care base plate
ACTIVE COMPARATORStandard care are the participants own product and can have several manufacture and brand names
New ostomy base plate (SS)
EXPERIMENTALSS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name
Interventions
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
Eligibility Criteria
You may qualify if:
- Have given written Informed Consent
- Is at least 18 years old
- Has the mental capacity to understand the study guidelines and questionnaires
- Has had their ileostomy for at least 3 months
- Has an ileostomy with a diameter between 19-40 mm
- Is currently using a flat 2-piece product with with mechanical coupling
- Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
- Has experienced leakage under the base plate at least once a week over the last 2 weeks
You may not qualify if:
- Is pregnant or breast-feeding
- Currently receiving or has within the past 2 months received radio- and/or chemotherapy
- Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
- Is currently using a convex base plate
- Participating in other clinical studies or has previously participated in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (11)
Sygehus Sønderjylland i Aabenraa
Aabenraa, 6200, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Hôpital Nord
Marseille, 13015, France
Hôpital Hôtel Dieu de Nantes
Nantes, 44093, France
Hôpital Lariboisière
Paris, 75475, France
CHRU La Milétrie
Poitiers, 86021, France
Hôpital de Pontchaillou, CHRU de Rennes
Rennes, 35033, France
Sanitätshaus Fürst GmbH
Passau, 94032, Germany
Landspitali University Hospital
Reykjavik, 108, Iceland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small number of subjects analyzed.
Results Point of Contact
- Title
- Tonny Karlsmark
- Organization
- Bispebjerg Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2011
First Posted
January 25, 2012
Study Start
May 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 13, 2015
Results First Posted
March 13, 2015
Record last verified: 2015-03