A Pilot Study of the Envision® Surface

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00405834

Enrollment

Registered

2006-11-30

Start date

2007-06-30

Completion date

2007-10-31

Last updated

2008-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Keywords

Pressure Ulcers

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

Interventions

DEVICEEnvision® Patient Support System

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026