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

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.

Study Overview

• Status: Terminated
• Conditions: Skin Condition; Leakage
• Intervention / Treatment: Device: Standard Care base plate; Device: New ostomy base plate (SS)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Sygehus Sønderjylland i Aabenraa
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Odense, Denmark, 5000
    • Odense Universitetshospital
• France
  • Marseille, France, 13015
    • Hopital Nord
  • Nantes cedex 1, France, 44093
    • Hôpital Hôtel Dieu de Nantes
  • Paris cedex 10, France, 75475
    • Hopital Lariboisiere
  • Poitiers cedex, France, 86021
    • CHRU La Milétrie
  • Rennes cedex 9, France, 35033
    • Hôpital de Pontchaillou, CHRU de Rennes
• Germany
  • Passau, Germany, 94032
    • Sanitätshaus Fürst GmbH
• Iceland
  • Reykjavik, Iceland, 108
    • Landspitali University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care base plate; Standard care are the participants own product and can have several manufacture and brand names	Device: Standard Care base plate; The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
Experimental: New ostomy base plate (SS); SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name	Device: New ostomy base plate (SS); The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): March 13, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: CP215OC