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Enrolling by invitation NCT07215546

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

— Observational Retrospective Review Cerclage Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Montage or Montage CT.
Who it may be relevant to
Registry conditions: Retrospective Review, Cerclage, Pain Management. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Cumulative Opiod Dose [Time frame: From admission until end of treatment/discharge, up to 8 weeks]
Secondary outcome measures (4)
  • Time to Discharge [Time frame: From admission until end of treatment/discharge, up to 8 weeks]
  • Time to Opioid Cessation [Time frame: From admission until end of treatment/discharge, up to 8 weeks]
  • Percent Discharged with Opioid Prescription [Time frame: From admission until end of treatment/discharge, up to 8 weeks]
  • Percent without Opioid Use [Time frame: From admission until end of treatment/discharge, up to 8 weeks]

Eligibility criteria

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.
  • Active systemic infection (.i.e: endocarditis).
  • Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse).
  • History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence)
  • Recent history of drug or alcohol abuse.
  • Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability.
  • Postsurgical life expectancy < 90 days in the opinion of the investigator.

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 2 centers
  • NCH Rooney Heart Institute — Naples
  • Washington University — St Louis

Publications

  • 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. PMID 12457323
  • 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. PMID 11576043
  • 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. PMID 11576042
  • 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. PMID 33930358
  • 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. PMID 32584934
  • 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. PMID 14500232
  • 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. PMID 11888737
  • 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. PMID 10343263

Identifiers

NCT: NCT07215546 · Abyrx PMRCT 25-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗