Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 7:29 PM
Study NCT ID:
NCT03118960
Status:
UNKNOWN
Last Update Posted:
2017-04-18
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Pressure Ulcers', 'timeFrame': '12 Months', 'description': 'Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury'}], 'secondaryOutcomes': [{'measure': 'Incidence of pneumonia in each group', 'timeFrame': '12 months', 'description': 'Comparison between groups - in-house diagnosis of Pneumonia during study period by MD or sent to ER'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pressure Injury']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSubjects 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.\n\nSubjects 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects or their legal representative able to provide written consent for study.\n* subjects must be within the height and weight limits of the beds(height range 4\'2"-6\' 6" , weight range 50-300 lbs.)\n* subjects must have an existing treatable stage 2 or Stage 3 wound.\n\nExclusion Criteria:\n\n* Subjects with unstable spinal fractures.\n* Subjects with significant involuntary spasms.\n* Subjects with severe scoliosis. A user must be able to lie in a partial back lying position.\n* Subjects considered obese.'}, 'identificationModule': {'nctId': 'NCT03118960', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Northeast Center for Rehabilitation and Brain Injury'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Protocol 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Freedom Bed', 'description': 'Bed turns and positions subjects automatically for the healing and prevention of pressure injury', 'interventionNames': ['Device: Freedom Bed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II Low Air Loss/Alternating Pressure Mattress', 'description': 'Bed provides subjects with alternating pressure with low air loss mattress for the healing and prevention of pressure injury', 'interventionNames': ['Device: Group II Low Air Loss/Alternating Pressure Mattress']}], 'interventions': [{'name': 'Freedom Bed', 'type': 'DEVICE', 'description': 'This is an automatic rotational system in a bed designed to disburse capillary pressure', 'armGroupLabels': ['Freedom Bed']}, {'name': 'Group II Low Air Loss/Alternating Pressure Mattress', 'type': 'DEVICE', 'description': 'Subjects placed on the Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours', 'armGroupLabels': ['Group II Low Air Loss/Alternating Pressure Mattress']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12449', 'city': 'Lake Katrine', 'state': 'New York', 'country': 'United States', 'facility': 'Northeast Center for Rehabilitation and Brain Injury', 'geoPoint': {'lat': 41.98565, 'lon': -73.98819}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeast Center for Rehabilitation and Brain Injury', 'class': 'OTHER'}, 'collaborators': [{'name': 'Probed Medical USA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Occupational Therapy Coordinator', 'investigatorFullName': 'Annmarie Belfiglio', 'investigatorAffiliation': 'Northeast Center for Rehabilitation and Brain Injury'}}}}