Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy
NCT ID: NCT07215546
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
150 participants
OBSERVATIONAL
2025-10-31
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Personalized Postoperative Pain Management Following Thoracic Surgery in Adults
NCT05525923
Postoperative Opioid-Sparing Effect of a Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia.
NCT04854577
Prediction and Characterization of Acute and Chronic Postoperative Pain
NCT01308385
Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
NCT00493909
Predicting Chronic Pain Following Breast Surgery
NCT04967352
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
Montage or Montage CT
Application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Montage or Montage CT
Application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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 or have a current immunosuppressive condition.
9. Active systemic infection (.i.e: endocarditis).
10. Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse).
11. History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence)
12. Recent history of drug or alcohol abuse.
13. Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability.
14. 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)
19 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abyrx, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aniq Darr, Ph.D.
Role: STUDY_DIRECTOR
Abyrx, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NCH Rooney Heart Institute
Naples, Florida, United States
Washington University
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Losanoff JE, Jones JW, Richman BW. Primary closure of median sternotomy: techniques and principles. Cardiovasc Surg. 2002 Apr;10(2):102-10. doi: 10.1016/s0967-2109(01)00128-4.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Abyrx PMRCT 25-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.