MedTrace Logo

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

NCT03118960 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-04-18

No results posted yet for this study

Summary

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.

Conditions

  • Pressure Injury

Interventions

DEVICE

Freedom Bed

This is an automatic rotational system in a bed designed to disburse capillary pressure

DEVICE

Group II Low Air Loss/Alternating Pressure Mattress

Subjects placed on the Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours

Sponsors & Collaborators

  • Probed Medical USA

    collaborator UNKNOWN

  • Northeast Center for Rehabilitation and Brain Injury

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-09-30
Completion
2017-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03118960 on ClinicalTrials.gov