Reinforced Sternal Closure Using Osteoconductive Biologic Bone Cement (Kryptonite) in Patients Undergoing Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change of lung function test values postoperatively compared to baseline value before surgery
研究概览
简要总结
Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG) in patients undergoing surgery for coronary artery disease. Given the increasing risk profile of contemporary cardiac surgery patients, sternal complications are subject to increase concomitantly. Despite advances in many areas of cardiac surgical procedures, innovation in sternal closure technique has been lacking and postoperative complications remain. In this study, the investigators aim to assess the effectiveness of using a novel osteoconductive biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an adjunct to conventional sternal closure in post CABG patients having median sternotomy.
The outcomes of interest for this study will include: pain, discomfort, lung function, wound healing and analgesic use. The investigators assume that the use of KryptoniteTM will decrease postoperative pain leading to improvement in postoperative lung function. This may also lead to improvement in patient recovery and decrease in postoperative complications.
The investigators will undertake a single-blinded randomized, controlled study consisting of patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to either Group A (usual closure with stainless steel wires) or Group B (usual closure with stainless steel wires plus application of bone cement). Each group will consist of 64 patients in a total of 128 patients. Lung function data using a spirometer will be collected preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data will be collected on the 1st to 5th postoperative days.
详细描述
Procedure Research assistants will be dedicated to participant recruitment, data collection, and assessment of sternal wounds. Upon admission, or scheduling for surgery, consecutive CABG surgery patients who will have median sternotomy will be approached by a research assistant for preoperative screening (to determine eligibility for the study). Thereafter, informed consent will be sought to examine their recovery for a period of approximately 16 post-operative weeks.
When undertaking the clinical trial, randomization of the participants will be achieved using an opaque envelope. Envelopes will be kept at the operation theatre and will be opened by a nurse or the surgeon prior to surgery. This envelope will also contain a data collection form to be completed by the surgeons (regarding bone quality, sternotomy, and number of sternal wires).
Following surgery, blinded research assistants will collect pain data from the participants on the 1st to 5th postoperative days. These will be measured using a 10-point numeric rating scale. The scales will be anchored with descriptors 0=none, 10=worst. These data will be collected at rest and after coughing. Lung function data (FEV1.0, FVC) will be collected using a bedside spirometer on the 3rd and 5th postoperative days. Other relevant clinical data (e.g., age, grafts used for and nature of surgery, analgesic use, other complications, length of stay) will be collected through a health record audit.
Once the participants are discharged, data collection will be done when they return to the clinic for follow-ups.
Additional Outcomes Other outcomes that will be monitored will include: postoperative death within 6 weeks, abnormal prolongation in wound healing, length of ICU stay, length of hospital stay, postoperative pleural effusion, necessity to evacuate effusion, atelectasis, pneumonia, reoperation requiring sternal reentry, sternal dehiscence, wound infection (superficial or deep), mediastinitis, amount of analgesia, and all other causes of morbidity.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting for elective isolated on-pump CABG surgery using left internal mammary artery as a graft, through first-time median sternotomy aged between 50 and 79, who provide informed consent to participate.
排除标准
- •Patients who: are in emergent need for surgery, have had prior median sternotomy, are not applicable to the use of left internal mammary artery as a graft, are at high-risk of early post-operative bleeding requiring reopening of chest (taking anti-platelet medication within 24 hours of surgery), have had previous radiotherapy to the chest, present in a clinical preoperative state that suggests a prolonged recovery (e.g., other concurrent illness such as significant respiratory disease or renal failure requiring dialysis, current use of steroids, residence in a long-term care facility, current substance abuse), or present with cognitive impairment (e.g., confusion, dementia, Alzheimer's disease) that would preclude completion of survey questions, will be ineligible.
结局指标
主要结局
Change of lung function test values postoperatively compared to baseline value before surgery
时间窗: Preop, 3 POD, and 5 POD
The investigators will evaluate the lung function preoperatively and postoperaatively by portable spirometer.
次要结局
- Assessment of the change in the trend of improvement of pain score after sternal closure(postoperatively, as in and outpatient)