Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Device: Coloplast test product; Device: SenSura Convex Light

Study type: Interventional

Funder types: Industry

Identifiers

NCT01994902

CP232

Details and patient eligibility

About

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

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

First Coloplast test product

Experimental group

Description:

The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light

Treatment:

Device: Coloplast test product

Device: SenSura Convex Light

First SenSura Convex Light

Experimental group

Description:

The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product

Treatment:

Device: Coloplast test product

Device: SenSura Convex Light