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 range18 Years

SexALL

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

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