Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

Skin Condition Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01517178
• Other study ID #: CP215OC
• Status: Terminated
• Phase: Phase 3
• First received: June 24, 2011
• Last updated: March 3, 2015
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: March 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionFrance: Agence Nationale de Sécurité du Médicament et des produits de santéIceland:The National Bioethics CommitteeIceland: Icelandic Medicines Control AgencyFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leakage
• Skin Condition
• Skin Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Sygehus Sønderjylland i Aabenraa	Aabenraa
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense Universitetshospital	Odense
France	Hôpital Nord	Marseille
France	Hôpital Hôtel Dieu de Nantes	Nantes cedex 1
France	Hôpital Lariboisière	Paris cedex 10
France	CHRU La Milétrie	Poitiers cedex
France	Hôpital de Pontchaillou, CHRU de Rennes	Rennes cedex 9
Germany	Sanitätshaus Fürst GmbH	Passau
Iceland	Landspitali University Hospital	Reykjavik

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No