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
|Condition or disease||Intervention/treatment||Phase|
|Pressure Injury||Device: Freedom Bed Device: Group II Low Air Loss/Alternating Pressure Mattress||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Incidence of Pressure Ulcers [ Time Frame: 12 Months ]Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury
- 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
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
|United States, New York|
|Northeast Center for Rehabilitation and Brain Injury|
|Lake Katrine, New York, United States, 12449|