Pressure Injury, Pressure Ulcer
Conditions
Brief summary
This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.
Detailed description
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.
Interventions
DEVICEDabir 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.
Sponsors
The Cleveland Clinic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient developing new perioperative pressure ulcers | 5 days from operation | New pressure ulcers, any stage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pressure ulcer stage | 5 day from operation | Pressure ulcer stage, according to NPUAP staging system |
| Number of wound care consultations | 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 |
Countries
United States
Outcome results
None listed