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Completed

NCT Number: NCT03884634

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

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

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Key information

Conditions

Pressure Ulcer Pressure Injury Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dabir Micropressure Overlay

Device

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.

Primary outcomes

  1. Number of patient developing new perioperative pressure ulcers

    Time frame: 5 days from operation

    New pressure ulcers, any stage

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 21, 2019
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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