ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Envision® Surface Evaluation

This study has been completed.
Study NCT00405795.   Last updated on July 1, 2008.   Information provided by Hill-Rom

This Tabular View shows the required WHO registration data elements as marked by

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.

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.

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:

  • 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
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 
Principal Investigator:     Susan Levy, MD     Levindale hebrew Geriatric Center and Hospital    
Study Director:     Cathie Papantonio, RN,BSN,CWCN     Levindale Hebrew Geriatric Center and Hospital    
Information Provided By Hill-Rom
Verification Date July 2008
First Received Date  November 28, 2006
Last Updated Date July 1, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers