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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
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peristomal Skin Complication Device: CASTLE barrier Not Applicable

Detailed Description:
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.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
CASTLE Barrier
 Device: CASTLE barrier
Prototype barrier to be used in place of current two piece device


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Security [ Time Frame: 30 days ]
    wear time leakage barrier erosion


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
York Teaching Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hollister Incorporated
Investigators
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Study Director: Richard Murahata, PhD Hollister Incorporated
More Information
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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
Keywords provided by Hollister Incorporated:
colostomy
ileostomy
irritant dermatitis
two piece barrier