Preliminary Evaluation of CASTLE Barrier Prototype UK
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ClinicalTrials.gov Identifier: NCT01530087 |
Recruitment Status :
Terminated
(Inability of site to recruit/enroll target population)
First Posted : February 9, 2012
Results First Posted : March 22, 2016
Last Update Posted : March 22, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peristomal Skin Complication | Device: CASTLE barrier | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | August 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment
CASTLE Barrier
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Device: CASTLE barrier
Prototype barrier to be used in place of current two piece device |
- Peristomal Skin Condition [ Time Frame: 1 - 30 days ]mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)
- Security [ Time Frame: 30 days ]wear time leakage barrier erosion

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530087
United Kingdom | |
York Teaching Hospital | |
York, United Kingdom, YO31 8HE |
Study Director: | Richard Murahata, PhD | Hollister Incorporated |
Responsible Party: | Hollister Incorporated |
ClinicalTrials.gov Identifier: | NCT01530087 |
Other Study ID Numbers: |
4518-O CIV-GB-11-07-001241 ( Registry Identifier: Eudamed ) |
First Posted: | February 9, 2012 Key Record Dates |
Results First Posted: | March 22, 2016 |
Last Update Posted: | March 22, 2016 |
Last Verified: | September 2015 |
colostomy ileostomy irritant dermatitis two piece barrier |