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

Completed

• Conditions: Pressure Injury; Pressure Ulcer
• Interventions: Device: Dabir Micropressure Overlay

• Registration Number: NCT03884634
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-02-20
• Study Start: 2019-03-01
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Primary Completion: 2021-10-30
• Study Completion: 2022-09-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6627

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dabir Microsurface Overlay Group	Dabir Micropressure Overlay	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).

Primary Outcome Measures

Name	Time	Method
Number of patient developing new perioperative pressure ulcers	5 days from operation	New pressure ulcers, any stage

Secondary Outcome Measures

Name	Time	Method
Pressure ulcer stage	5 day from operation	Pressure ulcer stage, according to NPUAP staging system
Number of wound care consultations	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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States