Envision® Surface Evaluation

This study has been completed.

First Received: November 28, 2006 Last Updated: July 1, 2008 History of Changes

Sponsor:	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

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores

U.S. FDA Resources

Further study details as provided by Hill-Rom:

Enrollment:	30
Study Start Date:	June 2007
Study Completion Date:	March 2008

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405795

Locations

United States, Maryland
Levindale Hebrew Geriatric Center and Hospital
Baltimore, Maryland, United States, 21215

Sponsors and Collaborators

Hill-Rom

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

More Information

No publications provided

Responsible Party:	Hill-Rom ( Gordon MacFarlane, PhD, Director Clinical Research )
Study ID Numbers:	MR-2005-083
Study First Received:	November 28, 2006
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00405795 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Hill-Rom:

Pressure Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

ClinicalTrials.gov processed this record on November 27, 2009