N/A
N=64
Safety and Performance of New 1-piece Ostomy Product
Stoma Ileostomy
Bottom Line
View on ClinicalTrials.gov: NCT01800916 ↗Enrolled (actual)
64
Serious AEs
1.1%
Results posted
May 2014
Primary outcome: Primary: Degree of Leakage — 50; 44; 41; 60 percentage of baseplates with no leakage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast Adhesive baseplate A (Device); Coloplast Adhesive baseplate B (Device); Coloplast Adhesive baseplate C (Device); SenSura 1-Piece (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
50; 44; 41; 60 | — |
Summary
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
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 bags themselves.
- Have an ileostomy with a diameter between 15 and 40 mm.
- Have had their ostomy for at least three months.
- Currently use a 1-piece flat ostomy appliance with open bag.
- Use minimum 1 ostomy appliance every second day.
- Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
- Must be able to use a custom cut ostomy appliance.
- Accept to test three 1-piece ostomy appliances in the investigation.
- Negative result of a pregnancy test for women of childbearing age (only DK).
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 months 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.
- Currently using ostomy belt.
- Currently using extended wear product.
- 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 (NCT01800916). 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.