Major Leg Wound Complications Between the Proximal and Distal Segments of Saphenous Veins Harvested by No-Touch Technique in Coronary Artery Bypass Graft Surgery: a Single-center Randomized Within-subject Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major leg wound complication at 6 days postoperatively
研究概览
简要总结
The optimum segment of No-Touch veins for bypassing is still undefined. The purpose of this study is to assess the incidence of leg wound complication after No-Touch harvesting of proximal segment of saphenous veins compared to distal segment of veins in the leg. Graft occlusion rates between the two segments of veins for bypassing will also be compared during follow-up.
详细描述
This is a prospective, single-center, open-label, randomized within-subject-controlled trial. We aim to randomize 100 patients undergoing isolated coronary artery bypass graft (CABG). We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. In each patient, one saphenous vein graft (SVG) will be randomized to be the proximal segment, while another will be the distal segment as control. Healing of leg wounds will be assessed on day 6 post-operatively. Follow-up will be performed via face-to-face interview until at least 1 year after the operation by CT angiography.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or older who undergo primary isolated open-chest CABG with two vein grafts, one to the left coronary territory and the other to the right, with or without cardiopulmonary bypass
排除标准
- •Concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
- •Redo CABG
- •Emergent CABG (cardiogenic shock, inotropic pressure support, IABP)
- •Severe vein varicosity as assessed after vein harvesting and before randomization
- •Use of vascular stapler for anastomosis
- •Endarterectomy of coronary artery during surgery
- •Left ventricular repair due to ventricular aneurysm
- •Concomitant life-threatening disease likely to limit life expectancy to less than two years
- •Severe renal insufficiency (i.e. creatinine >200 μmol/L)
- •Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
- •Participant of other ongoing clinical trials
结局指标
主要结局
Major leg wound complication at 6 days postoperatively
时间窗: 6 days postoperatively
a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure
次要结局
- Major leg wound complication during 3-month follow-up(3 month)
- Graft vessel occlusion at 3 month and 1 year(3 months and 1 year)