Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

To investigate the performance and safety of the three 2-piece convex ostomy appliances

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: Coloplast Test 1; Device: Coloplast Test 2; Device: Coloplast Test 3

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

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:

Subjects interested in participating in the clinical investigation must comply with the following criteria:

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 33mm or less
6. Have experienced 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 (adrenocortical hormone) in the peristomal area.
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).

6. Known hypersensitivity toward any of the test products

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coloplast Test 1; The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2 Finally the all subject test Coloplast Test 3	Device: Coloplast Test 1; Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance; Device: Coloplast Test 2; Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance; Device: Coloplast Test 3; Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
Experimental: Coloplast Test 2; The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1 Finally the all subject test Coloplast Test 3	Device: Coloplast Test 1; Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance; Device: Coloplast Test 2; Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance; Device: Coloplast Test 3; Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Leakage	The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)	14 days

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte P Jakobsen, MD, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 1, 2013
• First Submitted That Met QC Criteria: October 1, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CP230