Status:
COMPLETED
Vitala 12 Hour Wear Test With Convex Products
Lead Sponsor:
ConvaTec Inc.
Conditions:
End Colostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this phase II clinical trial is to assess the safety of the Vitala™ device during 12 hours of daily wear with convex products.
Eligibility Criteria
Inclusion
- Is of legal consenting age.
- Is able to read, write, and understand the study, the required procedures, and the study related documentation.
- Has signed the informed consent.
- Has an end colostomy of at least 12 weeks duration with formed or semi-formed effluent.
- Currently uses a convex skin barrier wafer or uses convex inserts into standard skin barrier wafers or is willing to wear SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® or SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes. Enrollment will target 15 current convex product users and 10 non convex users.
- The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® in 45mm or 57mm flange size with a stoma opening size from 13mm up to 50mm or the SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes.
- Is willing to remove and replace the skin barrier wafer after three days, more often if desired, during Stage 2.
- Has a stoma that protrudes no more than 2 cm at rest (lying down on back).
- Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
- Is willing to participate in the trial for a total of 43 days.
- Is willing to meet with the investigator for a total of 5 scheduled visits plus additional visits as deemed necessary by the investigator.
- Has the ability to do complete self-care.
Exclusion
- Has known skin sensitivity to any component of the products being tested.
- Has a skin rating of "2" or greater according to the Skin Rating Scale.
- Has peristomal ulcerations, peristomal pressure necrosis, parastomal hernia, Caput Medusa or mucocutaneous separation.
- Is receiving radiation in the area of the pouching system.
- Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
- Requires a pouch belt while wearing Vitala™.
- Requires a moldable skin barrier.
- Has participated in a clinical study within the past 30 days.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01138709
Start Date
February 1 2010
End Date
April 1 2010
Last Update
December 7 2022
Active Locations (5)
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1
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Tucson, Arizona, United States, 85742
2
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Jacksonville, Florida, United States, 32217
3
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Kansas City, Missouri, United States, 64119
4
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Saint Joseph, Missouri, United States, 64506