Status:

COMPLETED

A Pilot Study of the Envision® Surface

Lead Sponsor:

Hill-Rom

Conditions:

Pressure Ulcers

Eligibility:

All Genders

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 acceptan...

Eligibility Criteria

Inclusion

  • 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

  • Subject requires pulmonary treatment surface Subject declines consent

Key Trial Info

Start Date :

June 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00405834

Start Date

June 1 2007

End Date

October 1 2007

Last Update

July 4 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Sinai Hospital of Baltimore

Baltimore, Maryland, United States, 21215