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

• Conditions: Retrospective Review; Cerclage; Pain Management

• Registration Number: NCT07215546
• Lead Sponsor: Abyrx, Inc.

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-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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-25
• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Primary Completion: 2025-12
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Time to Discharge	From admission until end of treatment/discharge, up to 8 weeks	Postoperative time to achieving hospital discharge criteria (TTHDC) measured in hours from entry into the postoperative ICU to the time a patient meets hospital discharge criteria.
Time to Opioid Cessation	From admission until end of treatment/discharge, up to 8 weeks	Time to opioid cessation (TTOC) measured in hours from entry into the postoperative ICU to the first time point at which a patient achieved a sustained period of at least 24 consecutive hours.
Percent Discharged with Opioid Prescription	From admission until end of treatment/discharge, up to 8 weeks	Percentage of patients discharged with an opioid prescription (DWOP) based on the number of patients who received a prescription for an opioid medication at hospital discharge.
Percent without Opioid Use	From admission until end of treatment/discharge, up to 8 weeks	Percentage of patients with no opioid analgesic use (NOU) based on the number of patients who did not receive any opioid medication from entry into the postoperative ICU through the time of achieving hospital discharge criteria.

Trial Locations

Locations (2)

NCH Rooney Heart Institute; 🇺🇸 Naples, Florida, United States

Washington University; 🇺🇸 St Louis, Missouri, United States