Preliminary Evaluation of CASTLE Barrier Prototype UK

Study Overview
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Brief Summary
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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
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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.

Official Title
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Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas

Conditions
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Peristomal Skin Complication

Intervention / Treatment
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* Device: CASTLE barrier


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>CASTLE Barrier | Device: CASTLE barrier<br>* Prototype barrier to be used in place of current two piece device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristomal Skin Condition | mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis) | 1 - 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Security | wear time leakage barrier erosion | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colostomy, ileostomy, irritant dermatitis, two piece barrier