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

Not Applicable

Completed

• Conditions: Stoma - Ileostomy
• Interventions: Device: Coloplast Test product Y; Device: Coloplast Test product Z

• Registration Number: NCT01957475
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Results First Submitted: 2014-07-21
• Results First Submitted QC: 2014-07-21
• Results First Posted: 2014-08-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Coloplast Test product Y, Then Coloplast Test product Z	Coloplast Test product Z	The subjects first test test product Y and after cross-over test product Z
First Coloplast Test product Z; then Coloplast Test product Y	Coloplast Test product Z	The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y
First Coloplast Test product Z; then Coloplast Test product Y	Coloplast Test product Y	The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y
First Coloplast Test product Y, Then Coloplast Test product Z	Coloplast Test product Y	The subjects first test test product Y and after cross-over test product Z

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	14 days	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.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark