Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

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Detailed Description

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Conditions

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Ileostomy - Stoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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First Coloplast Test 1

The subjects first test their own product to collect a baseline measurement

The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2

Group Type EXPERIMENTAL

Coloplast Test 1

Intervention Type DEVICE

Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance

Coloplast Test 2

Intervention Type DEVICE

Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance

First Coloplast Test 2

The subjects first test their own product to collect baseline measurements

The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1

Group Type EXPERIMENTAL

Coloplast Test 1

Intervention Type DEVICE

Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance

Coloplast Test 2

Intervention Type DEVICE

Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance

Interventions

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Coloplast Test 1

Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance

Intervention Type DEVICE

Coloplast Test 2

Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Subjects must comply with the following criteria in order to participate in the investigation:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33 mm or less
6. Have experience leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)
2. Are pregnant or breastfeeding
3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
6. Are currently participating in another clinical investigation or has previously participated in this investigation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No