Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Abyrx, Inc.
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cumulative Opiod Dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Recent CPR.
- •Previous cardiac surgery (redo sternotomy).
- •Emergency surgery (operative intervention within 24 hrs of assessment).
- •Chronic lung disease.
- •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.
- •Participation in another clinical trial.
- •Patients who had Patient-Controlled Analgesia (PCA) devices after surgery.
- •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)
结局指标
主要结局
Cumulative Opiod Dose
时间窗: From admission until end of treatment/discharge, up to 8 weeks
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.
次要结局
- Time to Discharge(From admission until end of treatment/discharge, up to 8 weeks)
- Time to Opioid Cessation(From admission until end of treatment/discharge, up to 8 weeks)
- Percent Discharged with Opioid Prescription(From admission until end of treatment/discharge, up to 8 weeks)
- Percent without Opioid Use(From admission until end of treatment/discharge, up to 8 weeks)