Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

Recruiting

• Conditions: Clinical Outcome of Pericardial Closure Using Gentrix

• Registration Number: NCT06136182
• Lead Sponsor: Methodist Health System

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 Center(MMMC) 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 Matrix(ECM) pericardial patch using information gathered from the patient's electronic health record (EHR). The main outcome measures of post-operative Length of Stay(LOS), 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 Timeline

• Study Start: 2023-05-12
• Study First Submitted: 2023-07-06
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-05-12
• Study Completion: 2024-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 489

Inclusion Criteria

• Must have undergone a Coronary Artery Bypass Grafting(CABG) or valve repair/replacement surgery requiring pericardial reconstruction.

CABG or valve repair/replacement surgery must have been either elective or urgent status

Exclusion Criteria

-CABG or valve repair/replacement surgery classified as emergent status Surgery classified as redo-sternotomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative hospital LOS	30 days	30-day all-cause unplanned readmissions after discharge; * Significant pleural effusion requiring thoracentesis within 30 days of surgery; * Significant pleural effusion requiring thoracentesis within 60 days of surgery

Trial Locations

Locations (2)

Clinical Research Institute at Methodist Health System; 🇺🇸 Dallas, Texas, United States

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States