Preliminary Evaluation of CASTLE Barrier North American Prototype
| Tracking Information | |||||
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| First Received Date ICMJE | August 6, 2011 | ||||
| Last Updated Date | December 9, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Peristomal skin irritation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01413672 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Security [ Time Frame: 30 days ] [ Designated as safety issue: No ] wear time, lifting of barrier from skin, leakage |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preliminary Evaluation of CASTLE Barrier North American Prototype | ||||
| Official Title ICMJE | Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype | ||||
| Brief Summary | The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | subjects currently known to investigators |
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| Condition ICMJE | Peristomal Skin Complication | ||||
| Intervention ICMJE | Device: Use of CASTLE barrier
Test barrier to be used in place of normal barrier. Otherwise normal routine is followed |
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| Study Group/Cohort (s) | person with ostomy
Community dwelling subject with either colostomy or ileostomy and at least 3 months post-surgery.
Intervention: Device: Use of CASTLE barrier |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent Exclusion Criteria: presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01413672 | ||||
| Other Study ID Numbers ICMJE | 5075-O | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hollister Incorporated | ||||
| Study Sponsor ICMJE | Hollister Incorporated | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hollister Incorporated | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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