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

NeuroTherapia, Inc.

Status: Completed

Conditions: Pressure Ulcer; Pressure Injury

Treatments: Device: Dabir Micropressure Overlay

Study type: Observational

Funder types: Other

Identifiers

NCT03884634

18-928

Details and patient eligibility

About

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

Full 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.

Enrollment: 6,627 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

6,627 participants in 2 patient groups

Dabir Microsurface Overlay Group

Description:

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).

Treatment:

Device: Dabir Micropressure Overlay

Control Group

Description:

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).