Study Stopped
Inability of site to recruit/enroll target population
Preliminary Evaluation of CASTLE Barrier Prototype UK
Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas
2 other identifiers
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
March 22, 2016
CompletedMarch 22, 2016
September 1, 2015
1 month
February 7, 2012
September 22, 2015
February 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Security
30 days
Study Arms (1)
Treatment
EXPERIMENTALCASTLE Barrier
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
York Teaching Hospital
York, YO31 8HE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Global Clinical Affairs
- Organization
- Hollister Incorporated
Study Officials
- STUDY DIRECTOR
Richard Murahata, PhD
Hollister Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2012
First Posted
February 9, 2012
Study Start
January 1, 2012
Primary Completion
February 1, 2012
Study Completion
August 1, 2012
Last Updated
March 22, 2016
Results First Posted
March 22, 2016
Record last verified: 2015-09