A Pilot Study of the Envision® Surface

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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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

Conditions

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Pressure Ulcers

Keywords

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Pressure Ulcers

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Envision® Patient Support System

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hill-Rom

Principal Investigators

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Betsy Fisher, RN, CWOCN

Role: STUDY_DIRECTOR

Sinai Hospital of Baltimore / Lifebridge Health

Locations

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Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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CR-0065

Identifier Type: -

Identifier Source: org_study_id