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| Descriptive Information Fields | |||||||||
| Brief Title † | Envision® Surface Evaluation | ||||||||
| Official Title † | Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers | ||||||||
| Brief Summary | This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Pressure Ulcer | ||||||||
| Intervention † | Device: Envision® Patient Support System | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 30 | ||||||||
| Start Date † | June 2007 | ||||||||
| Completion Date | March 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00405795 | ||||||||
| Organization ID | MR-2005-083 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Hill-Rom | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Hill-Rom | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | November 28, 2006 | ||||||||
| Last Updated Date | July 1, 2008 | ||||||||
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