Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

Not Applicable

Completed

• Conditions: Stoma Ileostomy

• Registration Number: NCT01994902
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the investigation was to investigate the performance and safety of a new ostomy product.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-18
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-11-03
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Results First Posted: 2016-01-12
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. Are at least 18 years of age and have full legal capacity.
2. Has had an ileostomy for at least 3 months.
3. Has used a convex ostomy product for the last month.
4. Has given signed informed consent.
5. Has experienced seeping under the baseplate at least three times during the last two weeks.
6. Currently using a SenSura Convex product with midi, maxi or magnum bags.
7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion Criteria

1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
2. Are pregnant or breastfeeding.
3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
6. Are currently participating in another clinical intervention study or have previously participated in this one.
7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
8. Has known hypersensitivity toward the test product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	28 +/- 3 days	The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).

Trial Locations

Locations (28)

TFS; 🇩🇰 Søborg, Denmark

Hopital du bocage; 🇫🇷 Dijon cedex, France

Hopital Robert Boulin; 🇫🇷 Libourne cedex, France

Hopital Claude Huriez; 🇫🇷 Lille cedex, France

Hopital Nord; 🇫🇷 Marseille, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Hopital de Haut Levêque; 🇫🇷 Pessac cedex, France

CHRU La Milétrie; 🇫🇷 Poitiers Cedex, France

BB medica medizinisches; 🇩🇪 Aachen, Germany

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