A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: Coloplast Test A; Device: Coloplast Test B; Device: Own product; Device: Coloplast Test C; Device: Coloplast Test D

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Had given written informed consent
2. Was at least 18 years of age
3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
4. Had an ileostomy with a diameter between 15-45 mm
5. Have had an ileostomy for at least 3 months
6. Currently used a 2-piece flat appliance

Exclusion Criteria:

1. Used irrigation during the investigation (flush stoma with water)
2. Currently received or had within the past 2 months received radio- and/or chemotherapy.
3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
4. Was pregnant or breast feeding
5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
6. Had a baseplate wear time of more than three days
7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Coloplast Test A, Coloplast Test B, Own product; The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days	Device: Coloplast Test A; Coloplast Test A is a new ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S; Device: Own product; Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
EXPERIMENTAL: Coloplast Test C , Coloplast Test D, Own product; The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days	Device: Own product; Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.; Device: Coloplast Test C; Coloplast Test C is a new ostomy appliance developed by Coloplast A/S; Device: Coloplast Test D; Coloplast Test D is a new ostomy appliance developed by Coloplast A/S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Leakage	Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).	14 days

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (ESTIMATE): February 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP222