Status:
UNKNOWN
Observational Evaluation of the Peristomal Skin Condition in Ostomates
Lead Sponsor:
ConvaTec Inc.
Conditions:
Ostomy
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the b...
Eligibility Criteria
Inclusion
- Subjects who are 18 years old and older.
- 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
- Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
- Subjects who are in a simultaneous clinical evaluation.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT01526967
Start Date
January 1 2012
End Date
December 1 2012
Last Update
December 17 2012
Active Locations (13)
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1
Independent Nurse Consultant
Tucson, Arizona, United States, 85742
2
John Muir Health Concord Campus
Concord, California, United States, 94520
3
Conn. Clinical Nursing Associate, LLC
Plymoth, Connecticut, United States, 06782
4
Baptist Home Health
Jacksonville, Florida, United States, 32207