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Envision® Surface Evaluation

This study has been completed.
Sponsor:
Information provided by:
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00405795
First received: November 28, 2006
Last updated: July 1, 2008
Last verified: July 2008

November 28, 2006
July 1, 2008
June 2007
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Complete list of historical versions of study NCT00405795 on ClinicalTrials.gov Archive Site
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Envision® Surface Evaluation
Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers

This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface.

This is a single site, open label, observational study to acquire initial clinical practice utilization information, product safety, and wound healing data, as defined by changes in wound volume and/or surface area, for patients with pressure ulcers placed on this surface.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Pressure Ulcer
Device: Envision® Patient Support System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2008
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Inclusion Criteria:

  • Subject Weight < 400 lbs. Subject has Stage II, III, or IV pressure ulcer on weight bearing aspect of the body Subject estimated length of stay at least 7 days Subject Ability to provide informed consent

Exclusion Criteria:

  • Inability to provide informed consent
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00405795
MR-2005-083
No
Gordon MacFarlane, PhD, Director Clinical Research, Hill-Rom
Hill-Rom
Not Provided
Principal Investigator: Susan Levy, MD Levindale hebrew Geriatric Center and Hospital
Study Director: Cathie Papantonio, RN,BSN,CWCN Levindale Hebrew Geriatric Center and Hospital
Hill-Rom
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP