Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT03884634
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2019-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6627}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patient developing new perioperative pressure ulcers', 'timeFrame': '5 days from operation', 'description': 'New pressure ulcers, any stage'}], 'secondaryOutcomes': [{'measure': 'Pressure ulcer stage', 'timeFrame': '5 day from operation', 'description': 'Pressure ulcer stage, according to NPUAP staging system'}, {'measure': 'Number of wound care consultations', 'timeFrame': 'From date of surgery until 30 days or the date of hospital discharge or the date of death from any cause, whichever came first, assessed up to 3 months', 'description': 'How often patients require consultation by the specialized wound care team for assessment and treatment of skin issues'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pressure Ulcer', 'Pressure Injury']}, 'descriptionModule': {'briefSummary': 'This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.', 'detailedDescription': 'This is a simple pragmatic systematic quality improvement study aimed at real-world evaluation of a device claimed to reduce pressure ulcers in patients undergoing cardiac surgery.\n\nData acquisition will be based on systematic sampling of cardiac surgery operations based on odd and even calendar dates. On odd dates the Dabir micropressure overlay will be functional on the operating room tables. On even dates the Dabir micropressure overlay will not be functional on the operating room tables. Data on baseline characteristics, operative parameters, and primary and secondary endpoints will be gathered from STS and wound care sources, which are routinely collected for all patients. There will be no additional patient information and data collected specifically for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be all adult patients undergoing cardiac surgery at Cleveland Clinic main campus during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All cases scheduled in the cardiac surgery OR suites at the CCF main campus.\n\nExclusion Criteria:\n\n* Patients who have had previous surgery within 5 days of enrollment in the study will excluded from analysis.'}, 'identificationModule': {'nctId': 'NCT03884634', 'briefTitle': 'Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery', 'orgStudyIdInfo': {'id': '18-928'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dabir Microsurface Overlay Group', 'description': 'Patients undergoing cardiac surgery with the Dabir Micropressure Overlay in place and turned ON (in addition to standard operating room table mattress and heating/cooling gel pad).', 'interventionNames': ['Device: Dabir Micropressure Overlay']}, {'label': 'Control Group', 'description': 'Patients undergoing cardiac surgery with the Dabir Micropressure Overlay in place and turned OFF (in addition to standard operating room table mattress and heating/cooling gel pad).'}], 'interventions': [{'name': 'Dabir Micropressure Overlay', 'type': 'DEVICE', 'description': 'The study intervention is the use of the Dabir micropressure overlay on the operating room table during surgical operations. The device is positioned on top of a standard foam pad and gel heat exchanger. The overlay is already in use in some (but not all) adult cardiac operating rooms.\n\nThe overlay will be present on the operating room table for all adult cardiac operations. On odd calendar dates the device will be powered on, and on even calendar dates the device will be powered off.', 'armGroupLabels': ['Dabir Microsurface Overlay Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Eric Roselli, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Roselli, M. D.', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}