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

Pressure Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03118960
• Other study ID #: Protocol 1
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2016
• Last updated: April 13, 2017
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2017
• Source: Northeast Center for Rehabilitation and Brain Injury
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Pressure Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Freedom Bed
This is an automatic rotational system in a bed designed to disburse capillary pressure
• 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

Locations

Country	Name	City	State
United States	Northeast Center for Rehabilitation and Brain Injury	Lake Katrine	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northeast Center for Rehabilitation and Brain Injury	Probed Medical USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pressure Ulcers	Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury	12 Months
Secondary	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