Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery

Study Overview
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Brief Summary
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This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.

Detailed Description
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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.

Official Title
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Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery

Conditions
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Pressure Ulcer, Pressure Injury

Intervention / Treatment
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* Device: Dabir Micropressure Overlay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All cases scheduled in the cardiac surgery OR suites at the CCF main campus. Exclusion Criteria: Patients who have had previous surgery within 5 days of enrollment in the study will excluded from analysis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dabir Microsurface Overlay Group<br>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<br>* 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.<br>|
| Control Group<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient developing new perioperative pressure ulcers | New pressure ulcers, any stage | 5 days from operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure ulcer stage | Pressure ulcer stage, according to NPUAP staging system | 5 day from operation | 
| Number of wound care consultations | How often patients require consultation by the specialized wound care team for assessment and treatment of skin issues | 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 |