N/A
Completed N=183
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
Ileostomy - Stoma
Source: ClinicalTrials.gov NCT01957488 ↗
Enrolled (actual)
183
Serious AEs
2.1%
Results posted
Sep 2014
Primary outcomePrimary: Leakage — 50; 61; 59 percentage of baseplates
Summary
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leakage |
50; 61; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and signed letter of authority (mandatory in DK)
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the products themselves
- Have an ileostomy with a diameter between 10 and 40 mm.
- Have had their ostomy for at least three months.
- Have within the last month used a 1-piece flat product with open bag
- Currently using midi or maxi bags
- Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.
- Be suitable for participation in the investigation
- Must be able to use custom cut product
- Negative result of a pregnancy test for women of childbearing age (only DK)
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 systemic steroid or local treatment in the peristomal area
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Has participated in the previous explorative Coloplast studies CP236 and CP237
- Are currently or during the study using ostomy belt
- Has a stoma below skin surface
- Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)
- Has known hypersensitivity towards any of the test products
Data sourced from ClinicalTrials.gov (NCT01957488). 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.