Ireland
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Enrolling by invitation Observational

Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy

NCT07215546 · tracked via the Priya Life Science USA tracker
Sponsor
Abyrx, Inc
Phase
Observational
Started
2025-10
Last updated
2025-10-10

Condition(s) studied

Retrospective ReviewCerclagePain Management

Investigational drug(s) / intervention(s)

Montage or Montage CT

Montage or Montage CT: Application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure.

Study 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-operative use of analgesic medication (including opioids) and compare the use against a control group consisting of patients operated by the same surgeon concurrently or prior to adoption of Montage or Montage-CT for use in sternotomy closure.

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female \> 19 years of age. 2. Underwent non-emergent cardiac surgery (isolated coronary artery by-pass grafting and/or isolated valve surgery). 3. Full median sternotomy approach - with/without cardiopulmonary bypass. Exclusion Criteria: 1. Recent CPR. 2. Previous cardiac surgery (redo sternotomy). 3. Emergency surgery (operative intervention within 24 hrs of assessment). 4. Chronic lung disease. 5. BMI \> 40. 6. Use of sternal plate systems for closure. 7. Recent antiplatelet therapy. 8. Previous radiotherapy to the chest; receiving immunosuppressive therapy or have a current immunosuppressive condition. 9. Active systemic infection (.i.e: endocarditis). 10. Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse). 11. History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence) 12. Recent history of drug or alcohol abuse. 13. Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability. 14. 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)

Primary outcome measure(s)

  • Cumulative Opiod Dose — From admission until end of treatment/discharge, up to 8 weeks
    1\. Cumulative opioid dose (COD) is measured from entry into the postoperative ICU through the time of achieving hospital discharge criteria. Opioid use will be quantified in morphine equivalents, using conversion factors based on Von Korff, et al.

Trial sites (2)

FacilityCityRegionStatus
NCH Rooney Heart Institute Naples Florida
Washington University St Louis Missouri
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07215546 on ClinicalTrials.gov ↗ ← All trials in the USA