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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

Tracking Information
First Submitted Date November 28, 2006
First Posted Date November 30, 2006
Last Update Posted Date July 4, 2008
Study Start Date June 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Pilot Study of the Envision® Surface
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
Brief Summary This study is to evaluate the clinical safety and effectiveness of the Envision® surface.
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Pressure Ulcers
Intervention Device: Envision® Patient Support System
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November¬†28,¬†2006)
30
Original Enrollment Same as current
Actual Study Completion Date October 2007
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00405834
Other Study ID Numbers CR-0065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gordon MacFarlane, PhD, Director of Clinical Research, Hill-Rom
Study Sponsor Hill-Rom
Collaborators Not Provided
Investigators
Study Director: Betsy Fisher, RN, CWOCN Sinai Hospital of Baltimore / Lifebridge Health
PRS Account Hill-Rom
Verification Date June 2007