N/A
Completed N=127
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
Ileostomy - Stoma
Source: ClinicalTrials.gov NCT01957553 ↗
Enrolled (actual)
127
Serious AEs
2.1%
Results posted
Sep 2014
Primary outcomePrimary: Preference — 65; 35 percentage of participants
Summary
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preference |
65; 35 | — |
Eligibility Criteria
Inclusion Criteria
- 1.Have given written informed consent and letter of authority (DK only)
- 2.Be at least 18 years of age and have full legal capacity.
- 3.Be able to handle the products her/himself
- 4.Have an ileostomy with a diameter between 10 and 40 mm.
- 5.Have had their ostomy for at least three months.
- 6.Be willing to use minimum 2 base plates every week
- 7.Currently use 2-piece flat mechanical coupling product with open bag 8
- 11.Negative result of a pregnancy test for women of childbearing age (only DK)
Exclusion Criteria
- 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- 3.Is pregnant or breastfeeding.
- 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
- 5.Has participated in the previous explorative study CP234
- 6.
- 7.Known hypersensitivity towards any of the test products
- 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
Data sourced from ClinicalTrials.gov (NCT01957553). 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.