N/A
N=52
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
Ileostomy · Colostomy
Bottom Line
View on ClinicalTrials.gov: NCT02362360 ↗Enrolled (actual)
52
Serious AEs
3.0%
Results posted
Oct 2016
Primary outcome: Primary: Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". — 56.9; 10.6; 29.4; 27.7 percentage of subjects answering
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast Test Product (Device); Comparator (Hollister) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". |
56.9; 10.6; 29.4; 27.7; 9.8; 42.6 | — |
Summary
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and in DK: signed a letter of authority
- Be at least 18 years of age and have full legal capacity
- Have had their ileostomy or colostomy for at least 3 months
- Able to use a baseplate size 15 to 40 mm
- Be able to handle the product themselves
- Normally experience faeces under the baseplate at least 3 times during 2 weeks
- Currently using a 2-piece flat product with mechanical coupling
- Willing to test both the Coloplast test product and the comparator product
- Willing to use an open bag size maxi during the investigation
- Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
- Willing to use at least 1 baseplate every 3rd day during the investigation
- Is able to use a custom cut product
- Be suitable for participating in the investigation
Exclusion Criteria
- Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
- Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
- Are pregnant or breastfeeding
- Are participating in other interventional clinical investigations or have previously participated in this investigation
- Use irrigation during the investigation (flush the intestines with water)
- Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
- Have a loop ostomy
- Have known hypersensitivity towards any of the products used in the investigation
Data sourced from ClinicalTrials.gov (NCT02362360). 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.