NCT01994876CompletedNot Applicable
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Degree of Leakage
Study Overview
Brief Summary
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must comply with the following criteria in order to participate in the investigation:
- •Are at least 18 years of age and have full legal capacity
- •Have had an ileostomy for at least 3 months
- •Have used a convex ostomy appliance for the last month
- •Have given written informed consent
- •Have an ileostomy with a diameter of 33 mm or less
- •Have experience leakage (seeping) under the baseplate at least two times over the last two weeks
Exclusion Criteria
- •Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- •Have a loop ostomy (also called double-barrel or ostomy with two outlets)
- •Are pregnant or breastfeeding
- •Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
- •Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
- •Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
- •Are currently participating in another clinical investigation or has previously participated in this investigation
Outcomes
Primary Outcomes
Degree of Leakage
Time Frame: 14 days
The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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