By InvitationNot Applicable

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

United States150 participantsStarted 2025-10

Plain-language 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.

Who can participate

Age range19 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Cumulative Opiod Dose

Timeframe: From admission until end of treatment/discharge, up to 8 weeks

Trial details

NCT IDNCT07215546

SponsorAbyrx, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12

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