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

Stoma - Ileostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957475
• Other study ID #: CP240
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: August 15, 2014
• Start date: April 2013
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stoma - Ileostomy

Intervention

Device:
• Coloplast Test product Y
Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
• Coloplast Test product Z
Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No