N/A
N=22
The Influence of Baseplate Adhesive on the Degree of Leakage
Colostomy Stoma · Ileostomy Stoma
Bottom Line
View on ClinicalTrials.gov: NCT01995357 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Degree of Leakage — 3.6; 2.4; 5.5; 4.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast Test A (Device); Coloplast Test B (Device); Standard product (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
3.6; 2.4; 5.5; 4.8; 3.7; 3.3 | — |
Summary
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and signed letter of authority
- Be at least 18 years of age and have full legal capacity
- Have had their ileostomy/colostomy for at least 3 months
- Have a stoma with a diameter between 15 and 36 mm
- Be able to handle the products themselves
- Be able to use a custom cut product
- Normally experience faeces under the base plate at least 3 times during 2 weeks
- 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
- Be willing to test the test products without using paste and/or ring
- Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
- Be suitable for participation in the investigation
- Be able to present a negative result of a pregnancy test - for women of childbearing age
Exclusion Criteria
- Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
- Are pregnant or breastfeeding
- Are participating in other interventional clinical investigations or have previously participated in this investigation
- Use irrigation during the investigation (flush the intestines with water)
- Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
- Have a loop stoma
- Have known hypersensitivity towards any of the test products (including adhesive remover)
Data sourced from ClinicalTrials.gov (NCT01995357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.