Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Institute at Methodist Health System | Dallas | Texas | United States | 75203 |
| 2 | Methodist Dallas Medical Center | Dallas | Texas | United States | 75203 |
Sponsors and Collaborators
- Methodist Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Bachar, B and Manna, B. (2022, August 8). Coronary Artery Bypass Graft. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK507836/
- 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.
- Valve repair or replacement (2022). In The Texas Heart Institute. https://www.texasheart.org/heart-health/heart-information-center/topics/valve-repair-or-replacement/
- 016.SUR.2023.M