N/A
N=29
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
Subjects With an Ileostomy
Bottom Line
View on ClinicalTrials.gov: NCT01800890 ↗Enrolled (actual)
29
Serious AEs
1.2%
Results posted
Aug 2014
Primary outcome: Primary: Degree of Leakage — 1.8; 1.8; 1.9; 1.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast A (Device); Coloplast B (Device); Coloplast C (Device); SenSura Click (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
1.8; 1.8; 1.9; 1.7 | — |
Summary
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and signed letter of authority form.
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the appliances themselves
- Have an ileostomy with a diameter between 15 and 40 mm.
- Have had their ostomy for at least three months.
- Use minimum 1 baseplate every third day.
- Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
- Must be able to use custom cut product
- Accept to test three 2-piece products within the study.
- Negative result of a pregnancy test for women of childbearing age.
Exclusion Criteria
- Use irrigation during the study (flush the stoma with water).
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- Are pregnant or breastfeeding.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
- More than three days wear time as usual change pattern.
- Currently using ostomy belt
- Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
- Have a loop ileostomy
- Known hypersensitivity towards any of the test products
- Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
Data sourced from ClinicalTrials.gov (NCT01800890). 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.