Text Size

A Pilot Study of the Envision® Surface

This study has been completed.
Sponsor:
Information provided by:
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00405834
First received: November 28, 2006
Last updated: July 1, 2008
Last verified: June 2007
History of Changes
  Purpose

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


Condition Intervention
Pressure Ulcers
 Device: Envision® Patient Support System

Study Type: Observational
Study Design: 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

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

Keywords provided by Hill-Rom:
Pressure Ulcers

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013