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| Sponsored by: |
Hill-Rom |
| Information provided by: | Hill-Rom |
| ClinicalTrials.gov Identifier: | NCT00405795 |
Purpose
This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface.
| Condition | Intervention |
|
Pressure Ulcer |
Device: Envision® Patient Support System |
| MedlinePlus related topics: | Pressure Sores |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers |
| Enrollment: | 30 |
| Study Start Date: | June 2007 |
| Study Completion Date: | March 2008 |
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |||||
| Levindale Hebrew Geriatric Center and Hospital | |||||
| Baltimore, Maryland, United States, 21215 | |||||
| Hill-Rom |
| Principal Investigator: | Susan Levy, MD | Levindale hebrew Geriatric Center and Hospital |
| Study Director: | Cathie Papantonio, RN,BSN,CWCN | Levindale Hebrew Geriatric Center and Hospital |
More Information
| Responsible Party: | Hill-Rom ( Gordon MacFarlane, PhD, Director Clinical Research ) |
| Study ID Numbers: | MR-2005-083 |
| First Received: | November 28, 2006 |
| Last Updated: | July 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00405795 |
| Health Authority: | United States: Institutional Review Board |
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