Clinical Trial: Preliminary Evaluation of CASTLE Barrier Prototype UK
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas
Brief Summary: The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.
Detailed Summary: This is a single-site, unblinded, historically controlled, first use in humans study of a stoma barrier with a new formulation. Approximately 34 subjects who are currently using a 2-piece tape bordered product and able and willing to wear a product will be enrolled. Each participant is provided with one box containing 20 of the test barriers to be used consecutively according to their normal routine. Each participant is also provided with a box containing 30 pouches selected to most closely resemble their current product. Participants are asked to record the time of application and time of removal of each test barrier and their assessment of relevant characteristics for each test barrier. A clinical evaluation of the peristomal skin is conducted at study entry, at approximately mid way through the study and again at its conclusion. Photographs are taken of the peristomal skin at each visit using a digital camera. Individual participation in terms of wearing the barrier is for 30 days or until the test barrier has been used up, whichever comes first. The study is comprised of 3 visits, an enrolment visit, a mid-study visit and a completion visit and a phone call at approximately day 7.
Sponsor: Hollister Incorporated
Current Primary Outcome: Peristomal Skin Condition [ Time Frame: 1 - 30 days ]
Original Primary Outcome: Peristomal skin irritation [ Time Frame: 30 days ]
Current Secondary Outcome: Security [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: Hollister Incorporated
Dates:
Date Received: February 7, 2012
Date Started: January 2012
Date Completion:
Last Updated: February 22, 2016
Last Verified: September 2015
