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NCT00405795 Clinical Trial

Envision® Surface Evaluation

Pressure Ulcer Clinical Trial

Official title:
Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00405795
Other study ID # MR-2005-083
Secondary ID
Status Completed
Phase N/A
First received November 28, 2006
Last updated July 1, 2008
Start date June 2007
Est. completion date March 2008

Study information
Verified date July 2008
Source Hill-Rom
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface.

Description:

This is a single site, open label, observational study to acquire initial clinical practice utilization information, product safety, and wound healing data, as defined by changes in wound volume and/or surface area, for patients with pressure ulcers placed on this surface.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Subject Weight < 400 lbs. Subject has Stage II, III, or IV pressure ulcer on weight bearing aspect of the body Subject estimated length of stay at least 7 days Subject Ability to provide informed consent

Exclusion Criteria:

- Inability to provide informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Envision® Patient Support System

Locations
Country Name City State
United States Levindale Hebrew Geriatric Center and Hospital Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

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