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

Phase 3

Terminated

• Conditions: Leakage; Skin Condition

• Registration Number: NCT01517178
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Status Verified: 2015-03
• Results First Submitted: 2015-03-03
• Results First Submitted QC: 2015-03-03
• Last Update Submitted: 2015-03-03
• Results First Posted: 2015-03-13
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Degree of Output Under the Base Plate (Leakage).	Each test product was assessed for 2 weeks.	Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).

Trial Locations

Locations (11)

Sygehus Sønderjylland i Aabenraa; 🇩🇰 Aabenraa, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Denmark

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, France

Sanitätshaus Fürst GmbH; 🇩🇪 Passau, Germany

Scroll for more (1 remaining)