A Pilot Study of the Envision® Surface

This study has been completed.

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

Sponsored by:	Hill-Rom
Information provided by:	Hill-Rom
ClinicalTrials.gov Identifier:	NCT00405834

Purpose

This study is to evaluate the clinical safety and effectiveness of the Envision® surface.

Condition	Intervention
Pressure Ulcers	Device: Envision® Patient Support System

MedlinePlus related topics: Pressure Sores

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Pilot Study of the Envision® Surface in a Patient Population at High Risk for or Who Have Pressure Ulcers: Evaluation of Pressure Ulcer Incidence, Changes in Existing Pressure Ulcers, Clinical Staff Satisfaction and Patient Comfort

Further study details as provided by Hill-Rom:

Enrollment:	30
Study Start Date:	June 2007
Study Completion Date:	October 2007

Detailed Description:

This study is to evaluate the clinical safety and effectiveness of the Envision® surface placed on the TotalCare® frame in pressure ulcer prevention and management, patient comfort, and staff acceptance in the critical care environment

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject weighs between 70 and 400 pounds Subject to remain on Envision Surface for at least 3 days Subject at risk for pressure ulcers (Braden Score < 14) or has existing ulcer of any stage Subject is able to provide voluntary consent

Exclusion Criteria:

Subject requires pulmonary treatment surface Subject declines consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405834

Locations

United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215

Sponsors and Collaborators

Hill-Rom

Investigators

Study Director:

Betsy Fisher, RN, CWOCN

Sinai Hospital of Baltimore / Lifebridge Health

More Information

No publications provided

Responsible Party:	Hill-Rom ( Gordon MacFarlane, PhD, Director of Clinical Research )
Study ID Numbers:	CR-0065
Study First Received:	November 28, 2006
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00405834 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Hill-Rom:

Pressure Ulcers

Study placed in the following topic categories:

Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

ClinicalTrials.gov processed this record on May 07, 2009