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

Abyrx, Inc.

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

Age range: 19–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

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…

Interventions

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

Locations (2)

NCH Rooney Heart Institute
Naples, Florida
Washington University
St Louis, Missouri

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

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

Conditions