TerminatedNot Applicable

Preliminary Evaluation of CASTLE Barrier Prototype UK

Stopped: Inability of site to recruit/enroll target population

United Kingdom3 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peristomal Skin Condition

Timeframe: 1 - 30 days

Trial details

NCT IDNCT01530087

SponsorHollister Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2015-09-22

View on ClinicalTrials.gov More Peristomal Skin Complication trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.