Observational Evaluation of the Peristomal Skin Condition in Ostomates
NCT ID: NCT01526967
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2012-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New moldable user
Subjects presenting with peristomal lesions with a traditional barrier and for whom a ConvaTec Moldable Technology™ Skin Barrier is used as a replacement.
No interventions assigned to this group
New osomate
Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subjects who agree to participate in the evaluation and who have signed the informed consent form.
* Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
* Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.
OR
* Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care.
Exclusion Criteria
* Subjects who are in a simultaneous clinical evaluation.
18 Years
ALL
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Qing Li, Ph.D, MD
Role: STUDY_CHAIR
ConvaTec Inc.
Locations
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Independent Nurse Consultant
Tucson, Arizona, United States
John Muir Health Concord Campus
Concord, California, United States
Conn. Clinical Nursing Associate, LLC
Plymoth, Connecticut, United States
Baptist Home Health
Jacksonville, Florida, United States
Porter Hospital
Valparaiso, Indiana, United States
Serena Group - Dr. Thomas Serena MD
Cambridge, Massachusetts, United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
St. Anthony's Medical Center
St Louis, Missouri, United States
ID Med Inc.
Columbus, Ohio, United States
RI Colorectal Clinic, LLC
Pawtucket, Rhode Island, United States
San Jacinto Methodist Hospital
Baytown, Texas, United States
NW Pavillion Ostomy Clinic
Renton, Washington, United States
Countries
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Other Identifiers
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MA-0509-12-U359
Identifier Type: -
Identifier Source: org_study_id