N/A
Completed N=10
An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
Source: ClinicalTrials.gov NCT02351817 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Product Acceptance — 0; 1 participants
Summary
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Product Acceptance |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and letter of authority
- Be at least 18 years of age and have full legal capacity
- Be able to handle the products her/himself
- Have an ileostomy with a diameter between 10 and 30 mm
- Willing to follow the product change schedule (one change per day)
- Have had their ostomy for at least three months
- Willing to use 1 piece open ostomy products during the test period
- Must be able to use a custom cut product
- Have intact skin
- Negative result of a pregnancy test for women of childbearing age
Exclusion Criteria
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
- Is pregnant or breastfeeding.
- Is participating in other interventional clinical investigations or have previously participated in this investigation
- Have a loop ileostomy
- Known hypersensitivity towards any of the test products
Data sourced from ClinicalTrials.gov (NCT02351817). 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.