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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014