Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136182
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-07-06
Brief Title:
Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery
Sponsor:
Methodist Health System
Organization:
Methodist Health System
Study Overview
Official Title:
Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A descriptive comparative project will be conducted to determine if there is a difference in outcomes for adult patients requiring pericardial reconstruction using CorMatrix compared to Gentrix
Detailed Description:
A descriptive comparative project will be conducted utilizing a retrospective chart review on patients at Methodist Mansfield Medical CenterMMMC undergoing cardiac surgery requiring pericardial repair between the dates of January 1 2017 through December 31 2022 The project will compare outcomes of a pre- and post-intervention following use of Gentrix ECM and the CorMatrix Extracellular MatrixECM pericardial patch using information gathered from the patients electronic health record EHR The main outcome measures of post-operative Length of StayLOS all-cause unplanned readmission within 30 days and significant pleural effusion requiring thoracentesis within 30-days and 60 days as well as long-term 12 months patient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None