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

The Cleveland Clinic6,627 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

6,627

Conditions

Pressure Ulcer Pressure Injury

Interventions

Dabir Micropressure OverlayDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of patient developing new perioperative pressure ulcers

New pressure ulcers, any stage

Time frame: 5 days from operation

Secondary Outcomes

Pressure ulcer stage

Pressure ulcer stage, according to NPUAP staging system

Time frame: 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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.