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

NCT ID: NCT03118960

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-11-30

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.

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.

Conditions

Pressure Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Freedom Bed

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

Group Type: ACTIVE_COMPARATOR

Freedom Bed

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Group II Low Air Loss/Alternating Pressure Mattress

Intervention Type: DEVICE

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

Interventions

Freedom Bed

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Probed Medical USA

UNKNOWN

Sponsor Role: collaborator

Northeast Center for Rehabilitation and Brain Injury

OTHER

Sponsor Role: lead

Responsible Party

Annmarie Belfiglio

Occupational Therapy Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northeast Center for Rehabilitation and Brain Injury

Lake Katrine, New York, United States

Countries

United States

Other Identifiers

Protocol 1

Identifier Type: -

Identifier Source: org_study_id