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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Standard sternal cerclage closure with no settable putty applied in the timeframe (less than one year) immediately preceding use of the test device or concurrently. | ||
| Montage or Montage CT | Standard sternal cerclage closure (typically a minimum of 6 single loop closures) with application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montage or Montage CT | Device | Application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opiod Dose | 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. | From admission until end of treatment/discharge, up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge | 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. | From admission until end of treatment/discharge, up to 8 weeks |
| Time to Opioid Cessation |
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Inclusion Criteria:
Exclusion Criteria:
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)
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Males and females age > 19 years of age who have undergone non-emergent cardiac surgery (coronary artery by-pass grafting [CABG] and/or single valve replacement procedure).
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| Name | Affiliation | Role |
|---|---|---|
| Aniq Darr, Ph.D. | Abyrx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCH Rooney Heart Institute | Naples | Florida | 34102 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12457323 | Background | Losanoff JE, Richman BW, Jones JW. Risk analysis of deep sternal wound infection and mediastinitis in cardiac surgery. Thorac Cardiovasc Surg. 2002 Dec;50(6):385. doi: 10.1055/s-2002-35738. No abstract available. | |
| 11576043 | Background | Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. doi: 10.1034/j.1399-6576.2001.450804.x. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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. |
| From admission until end of treatment/discharge, up to 8 weeks |
| Percent Discharged with Opioid Prescription | 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. | From admission until end of treatment/discharge, up to 8 weeks |
| Percent without Opioid Use | 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. | From admission until end of treatment/discharge, up to 8 weeks |
| St Louis |
| Missouri |
| 63110 |
| United States |
| 11576042 | Background | Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9. doi: 10.1034/j.1399-6576.2001.450803.x. |
| 33930358 | Background | Ingason AB, Geirsson A, Gudbjartsson T, Muehlschlegel JD, Sigurdsson MI. The Incidence of New Persistent Opioid Use Following Cardiac Surgery via Sternotomy. Ann Thorac Surg. 2022 Jan;113(1):33-40. doi: 10.1016/j.athoracsur.2021.04.030. Epub 2021 Apr 27. |
| 32584934 | Background | Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445. |
| 14500232 | Background | Li AE, Fishman EK. Evaluation of complications after sternotomy using single- and multidetector CT with three-dimensional volume rendering. AJR Am J Roentgenol. 2003 Oct;181(4):1065-70. doi: 10.2214/ajr.181.4.1811065. No abstract available. |
| 11888737 | Background | Losanoff JE, Jones JW, Richman BW. Primary closure of median sternotomy: techniques and principles. Cardiovasc Surg. 2002 Apr;10(2):102-10. doi: 10.1177/096721090201000203. |
| 10343263 | Background | McGregor WE, Trumble DR, Magovern JA. Mechanical analysis of midline sternotomy wound closure. J Thorac Cardiovasc Surg. 1999 Jun;117(6):1144-50. doi: 10.1016/s0022-5223(99)70251-5. |
| 25882356 | Background | Lemaignen A, Birgand G, Ghodhbane W, Alkhoder S, Lolom I, Belorgey S, Lescure FX, Armand-Lefevre L, Raffoul R, Dilly MP, Nataf P, Lucet JC. Sternal wound infection after cardiac surgery: incidence and risk factors according to clinical presentation. Clin Microbiol Infect. 2015 Jul;21(7):674.e11-8. doi: 10.1016/j.cmi.2015.03.025. Epub 2015 Apr 14. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |