Status:
COMPLETED
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
Lead Sponsor:
Coloplast A/S
Conditions:
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01799239
Start Date
February 1 2013
End Date
March 1 2013
Last Update
September 30 2016
Active Locations (1)
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1
Skövde Hospital
Skövde, Sweden, 541 85