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The PI is no longer affiliated with Methodist Health System
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericardial Closure Using Gentrix Following Cardiac Surgery | Procedure | To determine feasibility and effectiveness of Gentrix for cardiac use, and if this product is patient population specific. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative hospital LOS | 30-day all-cause unplanned readmissions after discharge
| 30 days |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Darien Bradford, MD | Methodist Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute at Methodist Health System | Dallas | Texas | 75203 | United States | ||
| Methodist Dallas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bachar, B and Manna, B. (2022, August 8). Coronary Artery Bypass Graft. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK507836/ | ||
| 30876459 | 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. | |
| Background | Valve repair or replacement (2022). In The Texas Heart Institute. https://www.texasheart.org/heart-health/heart-information-center/topics/valve-repair-or-replacement/ |
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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.
Data Might be available by 2024 for up to 4 years
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
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| Dallas |
| Texas |
| 75203 |
| United States |