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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabir Micropressure Overlay | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient developing new perioperative pressure ulcers | New pressure ulcers, any stage | 5 days from operation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be all adult patients undergoing cardiac surgery at Cleveland Clinic main campus during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Roselli, M. D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 |