Clinical trial NCT01138709: Vitala 12 Hour Wear Test With Convex Products
Official title: Phase II Vitala 12 Hour Wear Test With Convex Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Colostomy
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.

Primary outcomes:
measure: Assessment of safety during 12 hours of Vitala™ device wear with convex products by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), and stomal vascularity.
timeFrame: 29 Days
measure: Assessment of the Efficacy in the Restoration of Continence (absence of fecal leakage around the device) for 29 days of Vitala™ daily wear according to the following parameters.
timeFrame: 29 Days
Secondary outcomes:
measure: Assessment of the Efficacy of Vitala™ device will also be evaluated for the following efficacy parameters.
timeFrame: 29 Days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Non-Institutional Investigator
state: Arizona
city: Jacksonville
country: United States
facility: ET Nursing Services
state: Florida
city: Kansas City
country: United States
facility: Restored Images
state: Missouri
city: Saint Joseph
country: United States
facility: Image Specialties
state: Missouri
city: Reynoldsburg
country: United States
facility: Non-Institutional Investigator
state: Ohio
Study officials:
affiliation: ConvaTec Inc.
name: Dheerendra Kommala, MD
role: STUDY_DIRECTOR
References: