A Pilot Study of the Envision® Surface

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

Completed

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Key information

Conditions

Pressure Ulcers Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Envision® Patient Support System

Device

Sponsors and collaborators

Lead sponsor

Hill-Rom

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Study completion: 2007
First posted: Nov 30, 2006
Registry last updated: Jul 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed