Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT03884634|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment|
|Pressure Ulcer Pressure Injury||Device: Dabir Micropressure Overlay|
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.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||6000 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||March 31, 2021|
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).
Device: 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.
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).
- Number of patient developing new perioperative pressure ulcers [ Time Frame: 5 days from operation ]New pressure ulcers, any stage
- Pressure ulcer stage [ Time Frame: 5 day from operation ]Pressure ulcer stage, according to NPUAP staging system
- Number of wound care consultations [ Time Frame: 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 ]How often patients require consultation by the specialized wound care team for assessment and treatment of skin issues
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884634
|Contact: Eric Roselli, M. D.||firstname.lastname@example.org|
|Contact: Kevin Hodgesemail@example.com|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Eric Roselli, M. D. 216-444-0995|
|Principal Investigator:||Eric Roselli, M. D.||The Cleveland Clinic|