Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
NCT ID: NCT03884634
Last Updated: 2023-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6627 participants
OBSERVATIONAL
2019-03-01
2022-09-15
Brief Summary
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Detailed Description
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Data 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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Dabir Microsurface Overlay Group
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).
Dabir Micropressure Overlay
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.
The 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.
Control Group
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).
No interventions assigned to this group
Interventions
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Dabir Micropressure Overlay
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.
The 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Eric Roselli, M. D.
Principal Investigator
Principal Investigators
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Eric Roselli, M. D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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18-928
Identifier Type: -
Identifier Source: org_study_id
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