The Influence of Baseplate Adhesive on the Degree of Leakage

Not Applicable

Completed

• Conditions: Ileostomy Stoma; Colostomy Stoma

• Registration Number: NCT01995357
• Lead Sponsor: Coloplast A/S

Brief Summary

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-01-19
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-02
• Last Update Submitted: 2015-02-02
• Results First Posted: 2015-02-03
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	10 (- 2 days)	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.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark