N/A
N=31
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
Ileostomy - Stoma
Bottom Line
View on ClinicalTrials.gov: NCT01799239 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Leakage (Percentage of All Baseplates With Leakage) — 34; 35 percentage baseplates with leakage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test product (Device); SenSura (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leakage (Percentage of All Baseplates With Leakage) |
34; 35 | — |
Summary
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- 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 55 mm
- Have had their ileostomy for at least 3 months
- Currently use a 1-piece flat ostomy appliance with open bag
- Use minimum 1 product every second day, i.e. maximum 2 days wear time
- Be suitable for participation in the study and for using a standard adhesive, flat base plate
- Must be able and willing to use custom cut products
- Accept to test two 1-piece products within the study period
Exclusion Criteria
- Use irrigation during the study period (flush the intestines with water)
- Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
- Currently receiving or have within the past month received systematic 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
- Currently using a ostomy belt
- Currently using extended wear product
- Have a loop ileostomy
- Known hypersensitivity towards any of the test products
- Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)
Data sourced from ClinicalTrials.gov (NCT01799239). 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.