The Influence of Baseplate Adhesive on the Degree of Leakage

Colostomy Stoma Clinical Trial

Official title:

The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995357
• Other study ID #: CP244
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: February 2, 2015
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• 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 influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2013
• Est. primary completion date: December 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. Be at least 18 years of age and have full legal capacity

3. Have had their ileostomy/colostomy for at least 3 months

4. Have a stoma with a diameter between 15 and 36 mm

5. Be able to handle the products themselves

6. Be able to use a custom cut product

7. Normally experience faeces under the base plate at least 3 times during 2 weeks

8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut

9. Be willing to test the test products without using paste and/or ring

10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct

11. Be suitable for participation in the investigation

12. Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy

2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area

3. Are pregnant or breastfeeding

4. Are participating in other interventional clinical investigations or have previously participated in this investigation

5. Use irrigation during the investigation (flush the intestines with water)

6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)

7. Have a loop stoma

8. Have known hypersensitivity towards any of the test products (including adhesive remover)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy Stoma

Intervention

Device:
• Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
• Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
• Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.

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 primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).; Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.	10 (- 2 days)	No