Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

Last updated: November 14, 2023
Sponsor: Methodist Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Pericardial Closure Using Gentrix Following Cardiac Surgery

Clinical Study ID

NCT06136182
016.SUR.2023.M
  • Ages 18-85
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have undergone a Coronary Artery Bypass Grafting(CABG) or valverepair/replacement surgery requiring pericardial reconstruction. CABG or valve repair/replacement surgery must have been either elective or urgent status

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 489
Treatment Group(s): 1
Primary Treatment: Pericardial Closure Using Gentrix Following Cardiac Surgery
Phase:
Study Start date:
May 12, 2023
Estimated Completion Date:
May 12, 2024

Study 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.

Connect with a study center

  • Clinical Research Institute at Methodist Health System

    Dallas, Texas 75203
    United States

    Active - Recruiting

  • Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.