Clinical trial NCT06136182: Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery
Official title: Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinical Outcome of Pericardial Closure Using Gentrix
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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.

Eligibility 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

Primary outcomes:
measure: Post-operative hospital LOS
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical Research Institute at Methodist Health System
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
References:
citation: Bachar, B and Manna, B. (2022, August 8). Coronary Artery Bypass Graft. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK507836/
citation: 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.
citation: Valve repair or replacement (2022). In The Texas Heart Institute. https://www.texasheart.org/heart-health/heart-information-center/topics/valve-repair-or-replacement/