[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07215546":3,"trial-entities:NCT07215546":113,"trial-summary:NCT07215546":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":20,"study_type":21,"primary_purpose":15,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":37,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":13,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":78,"overall_officials":79,"references":83,"see_also_links":112},"NCT07215546","Abyrx PMRCT 25-002","Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy","ENROLLING_BY_INVITATION","2026-04","2025-10","2025-10-10","Abyrx, Inc.","INDUSTRY",false,"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.",null,[17,18,19],"Retrospective Review","Cerclage","Pain Management",[],"OBSERVATIONAL",[],{"count":24,"type":25},150,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"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.",[29],[33],{"measure":34,"description":35,"timeFrame":36},"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\u002Fdischarge, up to 8 weeks",[38,41,44,47],{"measure":39,"description":40,"timeFrame":36},"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.",{"measure":42,"description":43,"timeFrame":36},"Time to Opioid Cessation","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.",{"measure":45,"description":46,"timeFrame":36},"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.",{"measure":48,"description":49,"timeFrame":36},"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.","ALL","19 Years","80 Years",{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion Criteria:\n\n1. Male or female \\> 19 years of age.\n2. Underwent non-emergent cardiac surgery (isolated coronary artery by-pass grafting and\u002For isolated valve surgery).\n3. Full median sternotomy approach - with\u002Fwithout cardiopulmonary bypass.\n\nExclusion Criteria:\n\n1. Recent CPR.\n2. Previous cardiac surgery (redo sternotomy).\n3. Emergency surgery (operative intervention within 24 hrs of assessment).\n4. Chronic lung disease.\n5. BMI \\> 40.\n6. Use of sternal plate systems for closure.\n7. Recent antiplatelet therapy.\n8. Previous radiotherapy to the chest; receiving immunosuppressive therapy or have a current immunosuppressive condition.\n9. Active systemic infection (.i.e: endocarditis).\n10. Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse).\n11. History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence)\n12. Recent history of drug or alcohol abuse.\n13. Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability.\n14. Postsurgical life expectancy \\\u003C 90 days in the opinion of the investigator.\n\n14\\. 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\u002For device on the sternum intraoperatively during surgery (e.g. On-Q Pain Relief System, Exparel etc)",[58,59],"ADULT","OLDER_ADULT",[61,70],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"NCH Rooney Heart Institute","Naples","Florida","34102","United States",{"lat":68,"lon":69},26.14234,-81.79596,{"facility":71,"city":72,"state":73,"zip":74,"country":66,"geoPoint":75},"Washington University","St Louis","Missouri","63110",{"lat":76,"lon":77},38.62727,-90.19789,[],[80],{"name":81,"affiliation":11,"role":82},"Aniq Darr, Ph.D.","STUDY_DIRECTOR",[84,88,91,94,97,100,103,106,109],{"pmid":85,"type":86,"citation":87},"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\u002Fs-2002-35738. No abstract available.",{"pmid":89,"type":86,"citation":90},"11576043","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\u002Fj.1399-6576.2001.450804.x.",{"pmid":92,"type":86,"citation":93},"11576042","Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9. doi: 10.1034\u002Fj.1399-6576.2001.450803.x.",{"pmid":95,"type":86,"citation":96},"33930358","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\u002Fj.athoracsur.2021.04.030. Epub 2021 Apr 27.",{"pmid":98,"type":86,"citation":99},"32584934","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\u002Fjamacardio.2020.1445.",{"pmid":101,"type":86,"citation":102},"14500232","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\u002Fajr.181.4.1811065. No abstract available.",{"pmid":104,"type":86,"citation":105},"11888737","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\u002F096721090201000203.",{"pmid":107,"type":86,"citation":108},"10343263","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\u002Fs0022-5223(99)70251-5.",{"pmid":110,"type":86,"citation":111},"25882356","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\u002Fj.cmi.2015.03.025. Epub 2015 Apr 14.",[],{"nct_id":4,"conditions":114,"biomarkers":118},[115,116,117],"Cardiac Surgery","Coronary Artery Bypass Surgery","Valve Surgery",[],{"nct_id":4,"found":13,"summary":15,"prompt_version":15}]