Vitala 12 Hour Wear Test With Convex Products

Completed · Not applicable

Conditions studied: End Colostomy

In brief

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.

Key facts

Study ID

NCT01138709

Run by

ConvaTec Inc.

People needed

27

Starts

2010-02-01

Expected to finish

2010-04-01

Last updated by the study team

2022-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Non-Institutional Investigator — Tucson, Arizona, United States
• ET Nursing Services — Jacksonville, Florida, United States
• Restored Images — Kansas City, Missouri, United States
• Image Specialties — Saint Joseph, Missouri, United States
• Non-Institutional Investigator — Reynoldsburg, Ohio, United States

Full record on ClinicalTrials.gov

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