N/A
N=20
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
Stoma - Ileostomy
Bottom Line
View on ClinicalTrials.gov: NCT01957475 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Degree of Leakage — 5.0; 5.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast Test product Y (Device); Coloplast Test product Z (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
5.0; 5.6 | — |
Summary
The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and signed letter of authority.
- Are at least 18 years of age and have full legal capacity.
- Have had their ileostomy for at least 3 months.
- Have used a 2-piece convex ostomy product during the last month.
- Are willing and able to comply with investigation procedures.
- Have an ileostomy with a diameter of 30 mm or less.
- Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.
Exclusion Criteria
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
- Are pregnant or breastfeeding.
- Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- Known hypersensitivity toward any of the test products.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
Data sourced from ClinicalTrials.gov (NCT01957475). 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.