Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

NCT ID: NCT06136182

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

489 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-12

Study Completion Date

2024-05-12

Brief Summary

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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

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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.

Conditions

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Clinical Outcome of Pericardial Closure Using Gentrix

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Pericardial Closure Using Gentrix Following Cardiac Surgery

To determine feasibility and effectiveness of Gentrix for cardiac use, and if this product is patient population specific.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Institute at Methodist Health System

Dallas, Texas, United States

Site Status RECRUITING

Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Colette Ngo Ndjom, MS

Role: CONTACT

214-947-1280 ext. 71280

Loretta W Bedell, MPH

Role: CONTACT

214-947-4680 ext. 74680

Facility Contacts

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Colette Ngo Ndjom, MS

Role: primary

410-947-4681 ext. 74681

Loretta W Bedell, MPH

Role: backup

214-947-4680 ext. 74680

Colette Ngo Ndjom, MS

Role: primary

214-947-4680 ext. 71280

Loretta Bedell, MPH

Role: backup

217-947-4681 ext. 74681

References

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Bachar, B and Manna, B. (2022, August 8). Coronary Artery Bypass Graft. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK507836/

Reference Type BACKGROUND

Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.

Reference Type BACKGROUND
PMID: 30876459 (View on PubMed)

Valve repair or replacement (2022). In The Texas Heart Institute. https://www.texasheart.org/heart-health/heart-information-center/topics/valve-repair-or-replacement/

Reference Type BACKGROUND

Other Identifiers

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016.SUR.2023.M

Identifier Type: -

Identifier Source: org_study_id

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