Vitala 12 Hour Wear Test With Convex Products

Convatec

Status: Completed

Conditions: End Colostomy

Treatments: Device: Vitala

Study type: Interventional

Funder types: Industry

Identifiers

NCT01138709

CC-0196-09-A721

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Convexity/Vitala

Experimental group

Description:

For all enrolled Subjects, STAGE 1 (Days 1 - 14 equals Convex Product Wear Period followed by, for those who successfully complete Stage I, weekly increases in wear time of the Vitala™ device beginning with 4 hours of daily wear per week (Days 15 to 21), followed by 8 hours of daily wear time per week (Day 22 to 28), followed by 12 hours of daily wear time (Days 29 to 43).

Treatment:

Device: Vitala