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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884634
• Other study ID #: 18-928
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: September 15, 2022

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6627
• Est. completion date: September 15, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Pressure Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient developing new perioperative pressure ulcers	New pressure ulcers, any stage	5 days from operation
Secondary	Pressure ulcer stage	Pressure ulcer stage, according to NPUAP staging system	5 day from operation
Secondary	Number of wound care consultations	How often patients require consultation by the specialized wound care team for assessment and treatment of skin issues	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