Envision® Surface Evaluation - Full Text View

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers

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

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

Keywords provided by Hill-Rom:

Pressure Ulcer

Study placed in the following topic categories:

Skin Diseases

Ulcer

Skin Ulcer

Pressure Ulcer

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Hill-Rom
Information provided by:	Hill-Rom
ClinicalTrials.gov Identifier:	NCT00405795