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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884634
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Roselli, M. D., The Cleveland Clinic

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

Condition or disease Intervention/treatment
Pressure Ulcer Pressure Injury Device: Dabir Micropressure Overlay

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 Device: Dabir 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.
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).


Outcome Measures
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Primary Outcome Measures :
  1. Number of patient developing new perioperative pressure ulcers [ Time Frame: 5 days from operation ]
    New pressure ulcers, any stage


Secondary Outcome Measures :
  1. Pressure ulcer stage [ Time Frame: 5 day from operation ]
    Pressure ulcer stage, according to NPUAP staging system

  2. Number of wound care consultations [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be all adult patients undergoing cardiac surgery at Cleveland Clinic main campus during the study period.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884634


Contacts
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Contact: Eric Roselli, M. D. 216-444-099 roselle@ccf.org
Contact: Kevin Hodges 216-213-0942 hodgesk@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Eric Roselli, M. D.    216-444-0995      
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Eric Roselli, M. D. The Cleveland Clinic
More Information
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Additional Information:

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Responsible Party: Eric Roselli, M. D., Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03884634    
Other Study ID Numbers: 18-928
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Crush Injuries
Pathologic Processes
 Skin Ulcer
Skin Diseases
Wounds and Injuries