Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
1 other identifier
observational
6,627
1 country
1
Brief Summary
This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedNovember 2, 2023
November 1, 2023
2.7 years
February 20, 2019
November 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patient developing new perioperative pressure ulcers
New pressure ulcers, any stage
5 days from operation
Secondary Outcomes (2)
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
Study Arms (2)
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).
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).
Interventions
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.
Eligibility Criteria
The study population will be all adult patients undergoing cardiac surgery at Cleveland Clinic main campus during the study period.
You may qualify if:
- All cases scheduled in the cardiac surgery OR suites at the CCF main campus.
You may not qualify if:
- Patients who have had previous surgery within 5 days of enrollment in the study will excluded from analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Roselli, M. D.
The Cleveland Clinic
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 20, 2019
First Posted
March 21, 2019
Study Start
March 1, 2019
Primary Completion
October 30, 2021
Study Completion
September 15, 2022
Last Updated
November 2, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share