Status:
ENROLLING_BY_INVITATION
Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy
Lead Sponsor:
Abyrx, Inc.
Conditions:
Retrospective Review
Cerclage
Eligibility:
All Genders
19-80 years
Brief Summary
This is a retrospective study based on analysis real world data obtained from hospitals that have adopted use of Montage or Montage-CT for use following sternotomy. The analysis will report the post-o...
Eligibility Criteria
Inclusion
- Male or female \> 19 years of age.
- Underwent non-emergent cardiac surgery (isolated coronary artery by-pass grafting and/or isolated valve surgery).
- Full median sternotomy approach - with/without cardiopulmonary bypass.
Exclusion
- Recent CPR.
- Previous cardiac surgery (redo sternotomy).
- Emergency surgery (operative intervention within 24 hrs of assessment).
- Chronic lung disease.
- BMI \> 40.
- Use of sternal plate systems for closure.
- Recent antiplatelet therapy.
- Previous radiotherapy to the chest; receiving immunosuppressive therapy or have a current immunosuppressive condition.
- Active systemic infection (.i.e: endocarditis).
- Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse).
- History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence)
- Recent history of drug or alcohol abuse.
- Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability.
- Postsurgical life expectancy \< 90 days in the opinion of the investigator.
- 14\. Moderate or severe pectus deformity. 16. Participation in another clinical trial. 17. Patients who had Patient-Controlled Analgesia (PCA) devices after surgery. 18. Patients who received a local anesthetic treatment and/or device on the sternum intraoperatively during surgery (e.g. On-Q Pain Relief System, Exparel etc)
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07215546
Start Date
October 1 2025
End Date
April 1 2026
Last Update
October 10 2025
Active Locations (2)
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1
NCH Rooney Heart Institute
Naples, Florida, United States, 34102
2
Washington University
St Louis, Missouri, United States, 63110