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Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.

NCT03048357 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-04-17

No results posted yet for this study

Summary

Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours on a standard Hospital Bed.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

Freedom Bed

Fully Integrated Lateral Rotation Bed System that automatically turns the patient to a specific angle in degrees between from 15-25 with dwell times between 1-120 minutes.

OTHER

Standard hospital bed

Caregiver turning patients to one side then the other every 2 hours for pressure relief over bony prominence's.

Sponsors & Collaborators

  • Probed Medical USA

    collaborator UNKNOWN

  • Northeast Center for Rehabilitation and Brain Injury

    lead OTHER

Principal Investigators

  • Lorraine McCalister, M.S. · Director Of Therapy, Northeast Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2017-09-01
Completion
2017-11-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048357 on ClinicalTrials.gov