Comparing outcomes of pericardial closure methods after heart surgery
Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery
Methodist Health System · NCT06136182
This study looks at how two different materials used for heart surgery closure affect recovery and complications in adult patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 489 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Methodist Health System (other) |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT06136182 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the clinical outcomes of adult patients undergoing cardiac surgery that requires pericardial reconstruction using two different materials: Gentrix and CorMatrix. By conducting a retrospective chart review of patients treated at Methodist Mansfield Medical Center from January 1, 2017, to December 31, 2022, the study will analyze various outcome measures, including post-operative length of stay, unplanned readmissions within 30 days, and significant pleural effusions requiring intervention. The findings will be derived from electronic health records to assess the effectiveness of these two pericardial closure methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults who have undergone elective or urgent coronary artery bypass grafting or valve repair/replacement surgery requiring pericardial reconstruction.
Not a fit: Patients who have had emergent surgeries or redo-sternotomies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective pericardial closure method, potentially improving recovery outcomes for patients undergoing cardiac surgery.
How similar studies have performed: While this study compares two specific methods of pericardial closure, similar studies have shown varying outcomes with different materials, indicating that this approach is relevant but not entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas and 1 other locations
- Clinical Research Institute at Methodist Health System — Dallas, Texas, United States (RECRUITING)
- Methodist Dallas Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Colette Ngo Ndjom, MS
- Email: MHSIRB@mhd.com
- Phone: 214-947-1280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clinical Outcome of Pericardial Closure Using Gentrix