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 | Unknown FDA Device

• 1 other identifier: Protocol 1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Pressure Ulcers

  Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury

  12 Months

Secondary Outcomes (1)

• Incidence of pneumonia in each group

  12 months

Study Arms (2)

Freedom Bed

ACTIVE COMPARATOR

Bed turns and positions subjects automatically for the healing and prevention of pressure injury

Device: Freedom Bed

Group II Low Air Loss/Alternating Pressure Mattress

ACTIVE COMPARATOR

Bed provides subjects with alternating pressure with low air loss mattress for the healing and prevention of pressure injury

Device: Group II Low Air Loss/Alternating Pressure Mattress

Interventions

Freedom Bed DEVICE

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

Freedom Bed

Group II Low Air Loss/Alternating Pressure Mattress DEVICE

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

Group II Low Air Loss/Alternating Pressure Mattress

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Northeast Center for Rehabilitation and Brain Injury: lead
• Probed Medical USA: collaborator

Study Sites (1)

Northeast Center for Rehabilitation and Brain Injury

Lake Katrine, New York, 12449, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapy Coordinator

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: April 18, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)