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A Pilot Study of the Envision® Surface

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00405834
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : July 4, 2008
Sponsor:
Information provided by:
Hill-Rom

Study Description
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Brief Summary:
This study is to evaluate the clinical safety and effectiveness of the Envision® surface.

Condition or disease Intervention/treatment
Pressure Ulcers Device: Envision® Patient Support System

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
Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: 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
Study Start Date : June 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405834


Locations
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United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
Hill-Rom
Investigators
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Study Director: Betsy Fisher, RN, CWOCN Sinai Hospital of Baltimore / Lifebridge Health
More Information
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Responsible Party: Gordon MacFarlane, PhD, Director of Clinical Research, Hill-Rom
ClinicalTrials.gov Identifier: NCT00405834    
Other Study ID Numbers: CR-0065
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: July 4, 2008
Last Verified: June 2007
Keywords provided by Hill-Rom:
Pressure Ulcers
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases