Effectiveness of the Freedom Bed as Compared to Alternating Pressure Mattress in Treatment of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and /or Spinal Cord Injury

Status unconfirmed · Not applicable

Conditions studied: Pressure Injury

In brief

This non-randomized clinical study will compare pressure injuries and the change in pressure injuries for subjects who are placed on the Freedom Bed compared to those placed on a standard Group II Low Air Loss/Alternating Pressure Mattress in the Ventilator Unit at Northeast Center for Rehabilitation and Brain Injury. Additionally, the incidence of pneumonia, urinary tract infections, circulatory performance, sleep deprivation and caregiver self-perception on performance will be monitored and documented.

Key facts

Study ID

NCT03118960

Run by

Northeast Center for Rehabilitation and Brain Injury

People needed

9

Starts

2016-09-01

Expected to finish

2017-11-01

Last updated by the study team

2017-04-18

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects or their legal representative able to provide written consent for study.
• subjects must be within the height and weight limits of the beds(height range 4'2"-6' 6" , weight range 50-300 lbs.)
• subjects must have an existing treatable stage 2 or Stage 3 wound.

You may not qualify if…

• Subjects with unstable spinal fractures.
• Subjects with significant involuntary spasms.
• Subjects with severe scoliosis. A user must be able to lie in a partial back lying position.
• Subjects considered obese.

Where it is running

• Northeast Center for Rehabilitation and Brain Injury — Lake Katrine, New York, United States

Full record on ClinicalTrials.gov

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