NCT00405834CompletedNot Applicable
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
Hill-Rom1 site in 1 country30 target enrollmentStarted: June 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
Study Overview
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
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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