N/A
Completed N=28
A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
Ileostomy - Stoma
Source: ClinicalTrials.gov NCT02064231 ↗
Enrolled (actual)
28
Serious AEs
1.7%
Results posted
Apr 2014
Primary outcomePrimary: Degree of Leakage — 6.4; 3.4; 7.0; 7.0 units on a scale
Summary
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
6.4; 3.4; 7.0; 7.0; 1.9 | — |
Eligibility Criteria
Inclusion Criteria
- Had given written informed consent
- Was at least 18 years of age
- Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
- Had an ileostomy with a diameter between 15-45 mm
- Have had an ileostomy for at least 3 months
- Currently used a 2-piece flat appliance
Exclusion Criteria
- Used irrigation during the investigation (flush stoma with water)
- Currently received or had within the past 2 months received radio- and/or chemotherapy.
- Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
- Was pregnant or breast feeding
- Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
- Had a baseplate wear time of more than three days
- Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)
Data sourced from ClinicalTrials.gov (NCT02064231). 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. Informational only — not medical advice.