N/A
N=20
A Clinical Investigation of New Ostomy Appliances
Leakage
Bottom Line
View on ClinicalTrials.gov: NCT01523756 ↗Enrolled (actual)
20
Serious AEs
1.7%
Results posted
Mar 2014
Primary outcome: Primary: Leakage Under the Base Plate Using a 24-point Scale — 4.5; 3.3; 4.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- test product 1: new ostomy base plate with Coloplast as manufacturer (Device); test product 2: new ostomy base plate with Coloplast as manufacturer (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leakage Under the Base Plate Using a 24-point Scale |
4.5; 3.3; 4.4 | — |
Summary
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years.
- Have had an ileostomy for more than 3 months.
- Have used convex products for the last 1 month.
- Has given written Informed Consent.
- Have an ileostomy with a diameter between 15 and 33 mm.
- Have inward peristomal area
Exclusion Criteria
- Have loop ostomy
- Pregnant or breastfeeding.
- Known allergy towards any of the product components or ingredients.
- Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
Data sourced from ClinicalTrials.gov (NCT01523756). 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.