NCT06136182

Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 489 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clinical Outcome of Pericardial Closure Using Gentrix

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2023-05-12
• Primary completion: 2024-05-12
• Completion: 2024-05-12
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

2 sites across 1 country: United States