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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

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ClinicalTrials.gov Identifier: NCT03118960
Recruitment Status : Unknown
Verified April 2017 by Annmarie Belfiglio, Northeast Center for Rehabilitation and Brain Injury.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Probed Medical USA
Information provided by (Responsible Party):
Annmarie Belfiglio, Northeast Center for Rehabilitation and Brain Injury

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.

Condition or disease Intervention/treatment Phase
Pressure Injury Device: Freedom Bed Device: Group II Low Air Loss/Alternating Pressure Mattress Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of Pressure Ulcers [ Time Frame: 12 Months ]
    Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury


Secondary Outcome Measures :
  1. Incidence of pneumonia in each group [ Time Frame: 12 months ]
    Comparison between groups - in-house diagnosis of Pneumonia during study period by MD or sent to ER



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118960


Locations
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United States, New York
Northeast Center for Rehabilitation and Brain Injury
Lake Katrine, New York, United States, 12449
Sponsors and Collaborators
Northeast Center for Rehabilitation and Brain Injury
Probed Medical USA

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Responsible Party: Annmarie Belfiglio, Occupational Therapy Coordinator, Northeast Center for Rehabilitation and Brain Injury
ClinicalTrials.gov Identifier: NCT03118960     History of Changes
Other Study ID Numbers: Protocol 1
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Crush Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases