Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances

Study Overview

• Status: Completed
• Conditions: Stoma - Ileostomy
• Intervention / Treatment: Device: Coloplast Test product Y; Device: Coloplast Test product Z

• Study Type: Interventional
• Enrollment (Actual): 20
• 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:

1. Have given written informed consent and signed letter of authority.
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ileostomy for at least 3 months.
4. Have used a 2-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have an ileostomy with a diameter of 30 mm or less.
7. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Participating in other interventional clinical investigations or have previously participated in this investigation.

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: First Coloplast Test product Z; then Coloplast Test product Y; The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y	Device: Coloplast Test product Y; Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance; Other Names: Coloplast 2-piece Convex appliance Test product Y; Device: Coloplast Test product Z; Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance; Other Names: Coloplast 2-piece convex appliance test product Z
Experimental: First Coloplast Test product Y, Then Coloplast Test product Z; The subjects first test test product Y and after cross-over test product Z	Device: Coloplast Test product Y; Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance; Other Names: Coloplast 2-piece Convex appliance Test product Y; Device: Coloplast Test product Z; Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance; Other Names: Coloplast 2-piece convex appliance test product Z

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Leakage	The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change.	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: April 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: October 1, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CP240