An Investigation Into the Efficacy of Pre-operative Long Saphenous Vein Mapping Using Ultrasound for Use in Coronary Artery Bypass Grafting to Reduce Vein Harvest Site Complications.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Surgical site infection at the conduit harvest site
研究概览
简要总结
The long saphenous vein is traditionally harvested for use as a conduit in coronary artery bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery. This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to improve patient and clinical outcomes.
详细描述
A vein from the leg is widely is widely harvested during coronary artery bypass grafting (CABG) surgery for bypass of diseased coronary arteries. This vein is called the long saphenous vein.
Currently, the long saphenous vein (LSV) is harvested blind by surgical practitioners with no imaging prior to surgery to decide on whether this vein is suitable for use in heart bypass surgery. This can result in fruitless incisions and result in additional unnecessary surgical wounds in the leg(s) to identify a suitable section of vein that can be used in the bypass operation. In these cases, excessive surgical trauma to the leg can increase the risk of a wound infection.
There is some evidence that ultrasound imaging of the LSV improves leg wound outcomes in patients having CABG surgery. Some studies have reported reductions in vein wound infection rates, vein harvest time, length of hospitalisation and length of wounds.
The purpose of this study will be to investigate the potential benefit of ultrasound imaging as a randomised control trial. One group will have ultrasound imaging of the long saphenous vein prior to heart bypass surgery. A second group will not undergo ultrasound imaging which is current practice at the Bristol Heart Institute.
Ultrasound imaging of the long saphenous vein will allow planning and selection of the most optimal segment of vein. This targeted approach will allow guidance of surgical incisions away from unsuitable segments and thus potentially improving leg wound outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Listed for CABG surgery with long saphenous vein harvesting.
- •Aged over 18 years.
- •Capable of providing informed consent.
- •Five days or more to consider participation prior to surgery if an outpatient or 2 days if an inpatient referred by their consultant.
- •Operative procedure to be undertaken at the Bristol Heart Institute.
排除标准
- •Operation within 48h hours if an inpatient or 5 days if an outpatient.
- •Aged below 18 years of age.
- •Incapable of providing informed consent i.e. confirmed diagnosis of dementia or other mental health conditions or unconscious.
- •Current participant in a different randomised control trial.
- •Pregnancy
- •Active cancer
- •Immunosuppressed.
- •Non-English speaker that requires a Trust translator.
研究组 & 干预措施
Pre-operative ultrasound imaging
Subjects that are randomly allocated to this group will have ultrasound imaging assessment of the long saphenous vein in both legs. This will allow assessment of the suitability of the long saphenous vein and marking of the distribution prior to heart bypass surgery to allow targeted harvesting of a bypass conduit.
干预措施: Ultrasound imaging of the long saphenous vein (Procedure)
Current protocol
This group will not undergo pre-operative ultrasound imaging of the long saphenous vein in accordance with current Trust protocols.
结局指标
主要结局
Surgical site infection at the conduit harvest site
时间窗: 30 days of CABG surgery
The ASEPSIS tool is a well established tool to quantify wound healing disturbances.
次要结局
- Patient questionnaire to assess wound/scar satisfaction and complications.(30 days from surgery)
- Ability to identify abnormal segments of vein on ultrasound and direct surgical excision away from such areas.(baseline)
- Time taken to harvest a suitable conduit.(intraoperative)
- Length of lower limb vein harvest wounds.(1 day Post-operation)
- Blood loss from the vein harvest wound(intraoperative)