Preliminary Evaluation of CASTLE Barrier Prototype UK

Not Applicable

Terminated

• Conditions: Peristomal Skin Complication
• Interventions: Device: CASTLE barrier

• Registration Number: NCT01530087
• Lead Sponsor: Hollister Incorporated

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 Description

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-02
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Study Completion: 2012-08
• Status Verified: 2015-09
• Results First Submitted: 2015-09-22
• Results First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Results First Posted: 2016-03-22
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• at least 18 years of age
• has colostomy or ileostomy
• current uses two piece tape bordered barrier
• has mild to moderate peristomal skin irritation
• cares for their stoma independently in the community
• at least 3 months post-operative
• provides informed consent

Exclusion Criteria

• has fistula on or near stoma
• has been involved in stoma care study in the last 30 days
• is pregnant or lactating (determined by interview only)
• has existing medical condition that would compromise their participation or follow-up
• currently uses convex ostomy products, paste and/or rings
• is allergic to test barrier components
• is undergoing chemo- or radiotherapy that may affect the interpretation of the results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	CASTLE barrier	CASTLE Barrier

Primary Outcome Measures

Name	Time	Method
Peristomal Skin Condition	1 - 30 days	mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)

Secondary Outcome Measures

Name	Time	Method
Security	30 days	wear time leakage barrier erosion

Trial Locations

Locations (1)

York Teaching Hospital; 🇬🇧 York, United Kingdom