Pressure InjuryNCT03118960
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
A study testing Freedom Bed and Group II Low Air Loss/Alternating Pressure Mattress in people with Pressure Injury, run by Northeast Center for Rehabilitation and Brain Injury at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Freedom Bed and Group II Low Air Loss/Alternating Pressure Mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeast Center for Rehabilitation and Brain Injury
Lake Katrine, New York, 12449
About this study
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
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.
Read the 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
- Being tested
- Freedom Bed, Group II Low Air Loss/Alternating Pressure Mattress
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom BedDevice
This is an automatic rotational system in a bed designed to disburse capillary pressure
Group II Low Air Loss/Alternating Pressure MattressDevice
Subjects placed on the Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Freedom Bed | Active comparator | Bed turns and positions subjects automatically for the healing and prevention of pressure injury Receives: Device: Freedom Bed |
| Group II Low Air Loss/Alternating Pressure Mattress | Active comparator | Bed provides subjects with alternating pressure with low air loss mattress for the healing and prevention of pressure injury Receives: Device: Group II Low Air Loss/Alternating Pressure Mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pressure Ulcers
Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury
Measured: 12 Months
Secondary outcomes (1)
Incidence of pneumonia in each group
Comparison between groups - in-house diagnosis of Pneumonia during study period by MD or sent to ER
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeast Center for Rehabilitation and Brain Injury
- Sponsor type
- University, hospital or other
- Collaborators
- Probed Medical USA
- Responsible party
- Principal investigator, Annmarie Belfiglio, Northeast Center for Rehabilitation and Brain Injury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118960
- Sponsor's protocol ID
- Protocol 1
- Status last verified
- Apr 2017
- First submitted
- 17 Nov 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03118960
- Acronym / sponsor ID
- Protocol 1
- Conditions
- Pressure Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Northeast Center for Rehabilitation and Brain InjuryUniversity, hospital or other
- Collaborators
- Probed Medical USA
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freedom Bed | Active comparator | Device: Freedom BedBed turns and positions subjects automatically for the healing and prevention of pressure injury |
| Group II Low Air Loss/Alternating Pressure Mattress | Active comparator | Device: Group II Low Air Loss/Alternating Pressure MattressBed provides subjects with alternating pressure with low air loss mattress for the healing and prevention of pressure injury |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freedom BedThis is an automatic rotational system in a bed designed to disburse capillary pressure | Device | Freedom Bed |
| Group II Low Air Loss/Alternating Pressure MattressSubjects placed on the Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours | Device | Group II Low Air Loss/Alternating Pressure Mattress |
Primary outcome
Incidence of Pressure Ulcers
Time frame: 12 Months
Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury
1 secondary outcome
Incidence of pneumonia in each group
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freedom Bed and Group II Low Air Loss/Alternating Pressure Mattress in people with Pressure Injury, run by Northeast Center for Rehabilitation and Brain Injury at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pressure Ulcers (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.