Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Preliminary Evaluation of CASTLE Barrier Prototype UK

This study has been terminated.
(Inability of site to recruit/enroll target population)
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01530087
First received: February 7, 2012
Last updated: February 22, 2016
Last verified: September 2015
  Purpose
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 Intervention
Peristomal Skin Complication
Device: CASTLE barrier

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • Peristomal Skin Condition [ Time Frame: 1 - 30 days ] [ Designated as safety issue: No ]
    mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)


Secondary Outcome Measures:
  • Security [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    wear time leakage barrier erosion


Enrollment: 3
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
CASTLE Barrier
Device: CASTLE barrier
Prototype barrier to be used in place of current two piece device

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530087

Locations
United Kingdom
York Teaching Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hollister Incorporated
Investigators
Study Director: Richard Murahata, PhD Hollister Incorporated
  More Information

Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01530087     History of Changes
Other Study ID Numbers: 4518-O  CIV-GB-11-07-001241 
Study First Received: February 7, 2012
Results First Received: September 22, 2015
Last Updated: February 22, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hollister Incorporated:
colostomy
ileostomy
irritant dermatitis
two piece barrier

ClinicalTrials.gov processed this record on December 02, 2016