Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 6,627
- Locations
- 1
- Primary Endpoint
- Number of patient developing new perioperative pressure ulcers
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Number of patient developing new perioperative pressure ulcers
Time Frame: 5 days from operation
New pressure ulcers, any stage
Secondary Outcomes
- Pressure ulcer stage(5 day from operation)
- 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)
Investigators
Eric Roselli, M. D.
Principal Investigator
The Cleveland Clinic