Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| NCH Rooney Heart Institute | Naples | Florida | |
| Washington University | St Louis | Missouri |
Other trials for the same condition
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