Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery
试验速览
- 阶段
- 2 期
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Sternal Revision
研究概览
简要总结
Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless steel wires. Augmenting sternal closure with techniques to enhance early bone stability should accelerate functional recovery from cardiac surgery thereby reducing post-operative pain, decreasing the need for narcotics, improving breathing and chest wall mechanics, stimulating early mobility and expediting hospital discharge.
This study is a randomized, single-centre, double-blind clinical study comparing the effects of Montage bone putty plus conventional wire closure vs conventional wire closure only on the post-operative recovery of cardiac surgery patients with full medial sternotomy.
详细描述
Patients undergoing cardiac surgery who are participating in the study will be randomized to either conventional wire cerclage or conventional wire closure plus the use of Montage bone putty. Patients will be followed post-operatively Day 3, 5 and at discharge as well as weeks 2, 4, 6 and months 3, 6 and 12.
Each visit will include: Pain assessment, wound assessment, sternal assessment, analgesic/antibiotic use, spirometry testing, quality of life questionaries (EQ-5D/HAQ) and determination of any adverse events. Chest x-rays will done at discharge and 3, 6, and 12 months to look at sternal healing.
This pilot study will include a total of 65 patient (40 conventional + putty / 20 conventional/ 5 initial open label with putty).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participants, study coordinator and care-givers are blinded to the assigned treatment arm. Participants may be able to guess which treatment group they have been assigned. This will be assessed at the end of the study by asking participants to identify the group to which they think they have been assigned.
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing non-emergent cardiac surgery ( cabg only or one valve procedure)
- •full median sternotomy approach, with or without cardiopulmonary bypass
- •English speaking
- •geographically accessible
- •written consent
排除标准
- •Recent CPR
- •previous cardiac surgery
- •emergency surgery ( within 24 hrs of assessment)
- •chronic lung disease
- •history of bleeding disorder
- •currently taking Vitamin E supplements
- •recent antiplatelet therapy
- •excessively poor baseline health-related quality of life or physical functioning
- •previous radiotherapy to chest, or on immunosuppressive drugs or current immunosuppressive condition
- •active significant systemic infection, history of recurrent infections,
- •cognitive impairment ( confusion, dementia, Alzheimer's, current substance abuse)
- •history of malignancy within the past year
- •recent history of significant alcohol or drug abuse
- •females who are pregnant, nursing, or child bearing potential who are not practicing a highly reliable birth control method
- •postsurgical life expectancy of less than 90 days
- •moderate to severe pectus deformity
- •participation in another study
结局指标
主要结局
Sternal Revision
时间窗: Intervention to 12 months post-operative
Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative.
Radiographic Sternal Integrity
时间窗: Intervention to 12 months post-operative
No radiographic evidence of bony instability as assessed through serial chest x-rays
Recovery of Respiratory Function
时间窗: Intervention to 6 weeks post-operative
The recovery of pulmonary functional capacity as measured by the return of forced vital capacity (FVC) to 80% or greater of the pre-operative baseline FVC measurement.
次要结局
- Post-operative Pain Assessment(Baseline to 12 months post - operative.)
- Sternal Wound Infections(Baseline to 12 months post-operative)
- Pulmonary Complications(Baseline to 6 weeks post-operative)
- Health Services resource usage(Baseline to 12 months post-operative)
- Rate of post-operative recovery(Baseline to 12 months post-operative)
研究者
Dr. Paul Fedak
Professor and Cardiac Surgeon
University of Calgary