Status:
WITHDRAWN
Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
Lead Sponsor:
Coloplast A/S
Conditions:
Leakage
Skin Condition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction: It is not an illness to have an ostomy, even though it is an indication of previous serious illness, such as cancer, which is the reason for approximately 80% of all ostomy operations. ...
Detailed Description
See brief summary
Eligibility Criteria
Inclusion
- List of Inclusion Criteria:
- Have given written informed consent.
- Are at least 18 years old.
- Have mental capacity to understand the study guidelines and questionnaires.
- Have had their ileostomy for at least 3 months
- Have an ileostomy with a diameter be-tween 19-40 mm.
- Are currently using a flat 1-piece product.
- Are able to change the product by them-selves or with help from a caregiver (e.g. spouse)
- Have experienced leakage under the base plate at least once a week over the last 2 weeks.
- List of Exclusion criteria.
- Pregnant or breast-feeding.
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted).
- Are currently using a convex product
- Participating in other clinical studies or have previously participated in this study
Exclusion
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01448629
Start Date
May 1 2011
End Date
July 1 2011
Last Update
February 7 2012
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