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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pressure Injury
• Intervention / Treatment: Device: Freedom Bed; Device: Group II Low Air Loss/Alternating Pressure Mattress

Detailed Description

Detailed Description: This study will include 9 ventilator or oxygen dependent subjects with comparable diagnoses, nutritional levels and Stage III and/or IV pressure injuries. Of the subjects selected, 5 subjects will be placed on Freedom Beds and 4 will be placed on Group II Low Air Loss/Alternating Pressure Mattresses for a period not less than 6 months. A waiver of informed consent is required prior to bed placement and data collection. Consented subjects will have primary and secondary diagnosis recorded, pressure injuries photographed and classified, assessment of ventilator/oxygen support measured, oxygenation levels, nutrition levels, and estimated cardiac condition. Subjects will receive daily treatment and wound care as prescribed by the attending physician with weekly measurements and reporting of values. Subjects will continue until they reach one of the study endpoints: 1) discharge from the ventilator unit, or 2) withdrawal of informed consent, or 3) completion of the 6-month study.

Subjects placed on Freedom Beds will be automatically turned in accordance with positions determined optimal and approved by the attending physician. All programmable turning angles, dwell times, head and leg elevations must be "dialed in" within a week of the study beginning. Any modification to the program during the study must be approved by the care team and documented accordingly.

Subjects placed on Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours. All turning and/or repositioning must be timed and documented.

The primary and secondary outcome measures documented on each subject throughout the week will be collected by the Clinical Research Coordinator (CRC) on a weekly basis and submitted to the Principal Investigator. The weekly reports will then be consolidated by the CRC into a monthly report and submitted to the Institutional Review Board (IRB), Principal Investigators (PI) and Supervising Authorities (SA) for review.

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Lake Katrine, New York, United States, 12449
      • Northeast Center for Rehabilitation and Brain Injury

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Freedom Bed; Bed turns and positions subjects automatically for the healing and prevention of pressure injury	Device: Freedom Bed; This is an automatic rotational system in a bed designed to disburse capillary pressure
Active Comparator: Group II Low Air Loss/Alternating Pressure Mattress; 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; Subjects placed on the Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pressure Ulcers	Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pneumonia in each group	Comparison between groups - in-house diagnosis of Pneumonia during study period by MD or sent to ER	12 months

Collaborators and Investigators

• Sponsor: Northeast Center for Rehabilitation and Brain Injury
• Collaborators: Probed Medical USA

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Spinal Cord Injuries; Crush Injuries
• Other Study ID Numbers: Protocol 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No