N/A
N=31
Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
Ileostomy - Stoma · Colostomy - Stoma
Bottom Line
View on ClinicalTrials.gov: NCT01957462 ↗Enrolled (actual)
31
Serious AEs
3.3%
Results posted
Aug 2014
Primary outcome: Primary: Degree of Leakage — 3.5; 3.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast Test V (Device); Coloplast Test X (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 |
3.5; 3.1 | — |
Summary
The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and signed letter of authority.
- Are at least 18 years of age and have full legal capacity.
- Have had their ostomy (ileo- or colostomy) for at least 3 months.
- Have used a 1-piece convex ostomy product during the last month.
- Are willing and able to comply with investigation procedures.
- Have a ostomy with a diameter of 33 mm or less.
Exclusion Criteria
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
- Are pregnant or breastfeeding.
- Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- Known hypersensitivity toward any of the test products.
- Use irrigation during the investigation (flush the stoma with water).
- Participating in other interventional clinical investigations or have previously participated in this investigation.
Data sourced from ClinicalTrials.gov (NCT01957462). 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.