Montage or Montage CT
DeviceApplication of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure.
NCT Number: NCT07215546
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.
Interested in participating?
Request Info19 year–80 year
All sexes
Observational
NCH Rooney Heart Institute, Naples, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure.
Time frame: From admission until end of treatment/discharge, up to 8 weeks
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Abyrx, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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