N/A
Completed N=74
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
Ileostomy - Stoma · Colostomy
Source: ClinicalTrials.gov NCT02517541 ↗
Enrolled (actual)
74
Serious AEs
0.7%
Results posted
Sep 2018
Primary outcomePrimary: Leakage Under the Baseplate (cm^2) — 9.2; 6.6 cm2
Summary
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leakage Under the Baseplate (cm^2) |
9.2; 6.6 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have an ileostomy or colostomy
- Have had their ostomy for at least 3 months
- Must use 1 piece open or closed ostomy products during the test period
- Currently using a 1 piece. flat product
- Must be able to use custom cut product
- Have intact peristomal skin
- Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
- Are evaluated to be suitable for a soft convex product
Exclusion Criteria
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
Data sourced from ClinicalTrials.gov (NCT02517541). 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.