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NCT00405834 Clinical Trial

A Pilot Study of the Envision® Surface

Pressure Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00405834
Other study ID # CR-0065
Secondary ID
Status Completed
Phase N/A
First received November 28, 2006
Last updated July 1, 2008
Start date June 2007
Est. completion date October 2007

Study information
Verified date June 2007
Source Hill-Rom
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Envision® Patient Support System

Locations
Country Name City State
United States Sinai Hospital of Baltimore Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

See also
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Completed NCT00507650 - Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers N/A
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Completed NCT01232764 - Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Trial in Long Term Care Phase 3
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Completed NCT03070925 - Prospective PuraPly™ AM Case Series Study N/A
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Completed NCT01348581 - Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing N/A
Completed NCT00763282 - Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury) N/A
Completed NCT00771238 - Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds N/A
Completed NCT01885962 - Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers N/A