Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Scar formation
研究概览
简要总结
Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. Several approaches have been proposed for treatment of chronic sternal wounds in these patients. however, Underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia, atherosclerosis and malnutrition have main role against wound repairing. In this study investigators aimed to treatment of patients with open heart surgery and need to strict monitoring of sternal wound repair by Platelet Rich Fibrin.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by segment elevation (ST) changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
- •The patient is scheduled to undergo coronary artery bypass surgery.
- •The patient does not possess any contraindication for cardiovascular magnetic resonance (CMR).
- •The patient is capable of giving informed consent.
- •The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
排除标准
- •The patient is over the age of 65 years.
- •The patient has previous myocardial infarction (MI) (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other left ventricular (LV) territory.
- •The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
- •The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
- •The patient has undergone previous cardiac surgery.
- •The patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion.
- •The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery.
- •The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
结局指标
主要结局
Scar formation
时间窗: post operative- until release from hospitalization up to 1 month
Appearance of operative scar diagnose by cardiothoracic surgeon
Wound Infection
时间窗: post operative- until release from hospitalization up to 1 month
wound infection incidence diagnose by cardiothoracic surgeon
Bruising
时间窗: post operative- until release from hospitalization up to 1 month
Average Bruise Change diagnose by cardiothoracic surgeon
次要结局
未报告次要终点