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

Enrolling by invitation

Conditions studied: Retrospective Review, Cerclage, Pain Management

In brief

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.

Key facts

Study ID

NCT07215546

Run by

Abyrx, Inc.

People needed

150

Starts

2025-10-01

Expected to finish

2026-04-01

Last updated by the study team

2025-10-10

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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)

Where it is running

• NCH Rooney Heart Institute — Naples, Florida, United States
• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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