Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

November 14, 2023 updated by: Methodist Health System
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

489

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Loretta W Bedell, MPH
  • Phone Number: 74680 214-947-4680
  • Email: mhsirb@mhd.com

Study Contact Backup

  • Name: Colette Ngo Ndjom, MS
  • Phone Number: 71280 214-947-1280
  • Email: MHSIRB@mhd.com

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:
          • Colette Ngo Ndjom, MS
          • Phone Number: 71280 214-947-4680
          • Email: mhsirb@mhd.com
        • Contact:
          • Loretta Bedell, MPH
          • Phone Number: 74681 217-947-4681
          • Email: mhsirb@mhd.com
        • Principal Investigator:
          • Darien Bradford, MD
        • Sub-Investigator:
          • Sheila Ford, DNP
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Clinical Research Institute at Methodist Health System
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • Must have undergone a CABG or valve repair/replacement surgery requiring pericardial reconstruction.
  • CABG or valve repair/replacement surgery must have been either elective or urgent status

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative hospital LOS
Time Frame: 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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Estimated)

May 12, 2024

Study Completion (Estimated)

May 12, 2024

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 016.SUR.2023.M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.

IPD Sharing Time Frame

Data Might be available by 2024 for up to 4 years

IPD Sharing Access Criteria

All study-related documents will be retained by the clinical research institute (CRI) until at least three years after study completion or according to local laws, whichever is longer

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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