Endoscopic Saphenous Vein Harvesting Versus Conventional Open Harvesting in Patients Undergoing Coronary Artery Bypass Grafting, Either Alone or in Combination With Another Cardiac Surgical Procedure, in Terms of the Clinical Impact of Surgical Wound Morbidity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Wound morbidity
研究概览
简要总结
The goal of this clinical trial is to compare two different techniques: endoscopic saphenous vein harvesting versus conventional open harvesting in patients undergoing coronary artery bypass grafting, either alone or in combination with another cardiac surgical procedure (valve surgery or arrhythmia surgery). The main questions the trial aims to answer are:
Does the endoscopic technique reduce surgical wound morbidity in terms of shorter hospital stays? Does endoscopic saphenous harvesting reduce the use of antibiotics for saphenectomy wound infections? Does the endoscopic technique reduce need for wound dressings due to necrosis and/or wound infection, and reduce need for analgesic treatment for wound pain? This prospective, randomized study will be conducted in the Cardiovascular Surgery Service at Hospital Clínico San Carlos.
Participants will be randomly assigned to a different saphenectomy technique. All patients will be assessed for saphenectomy wound complications upon discharge, and by phone call at 7 days, 1 month, and 3 months following the intervention.
详细描述
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Pain in the leg incisions will be assessed using a standarized pain scale.
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Antibiotic and analgesic requirements for infection or pain in the saphenous vein surgical wound will be documeted.
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The need for outpatient treatment or hospitalization due to surgical wounds will be evaluated.
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A surgical wound cosmetic satisfaction survey will be administered to participants.
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Images of the saphenectomy surgical wound will be collected at 1 month postoperatively.
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Major cardiovascular events will be monitored during follow-up visits or hospital admissions and recorded in the RECC database (local service database)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing coronary artery bypass grafting (CABG), alone or in combination with other surgery (valve or arrhythmia surgery), with or without cardiopulmonary bypass (CPB), in which preoperative evaluation includes the plan to use a short saphenous vein segment (alone or in addition to arterial conduits).
- •Availability of a surgeon or cardiac surgery resident trained in endoscopic harvesting in the operating room.
- •Patients undergoing myocardial revascularization surgeries with or without extracorporeal circulation.
- •Patients undergoing concomitant cardiac valve replacement surgery, atrial fibrillation surgery, and others, in addition to CABG
排除标准
- •Emergent surgery or procedures performed during cardiorespiratory arrest
- •Myocardial revascularization with arterial grafts only
- •Presence of varicose veins
- •History of infrainguinal vascular surgery
- •Presence of ulcers and/or active infection in the lower limbs
- •Previous stroke with neurological sequelae in the legs
- •History of deep vein thrombosis in the legs
- •Pregnancy
- •Age under 18 years
- •Lack of signed informed consent
研究组 & 干预措施
Endoscopic saphenectomy
Endoscopic vein harvesting in CABG surgery requiring a vein graft with or without extracorporeal circulation
干预措施: Harvesting of the saphenous vein graft (Procedure)
Conventional and open technique for saphenous vein harvesting
Using the conventional open technique for harvesting the saphenous vein in any type of surgery with or without extracorporeal circulation
干预措施: Harvesting of the saphenous vein graft (Procedure)
结局指标
主要结局
Wound morbidity
时间窗: From enrollment to the three-month follow-up visit
Days of hospital stay, use of antibiotics for saphenectomy wound infections, need for wound dressings due to necrosis and/or wound infection, and need for analgesic treatment for wound pain. 1. Length of Hospital Stay. Unit of Measure: Days 2. Use of Antibiotics for Saphenectomy Wound Infections Measure: Number of participants requiring oral or parenteral antibiotics due to wound infection. Unit of Measure: Participants 3. Need for Wound Dressings Due to Necrosis and/or Infection Measure: Number of participants requiring wound dressings due to necrosis and/or wound infection. Unit of Measure: Participants 4. Use of Analgesics for Wound Pain Measure: Number of participants requiring analgesic treatment for saphenectomy wound pain
次要结局
- Freedom from combined cardiac events(1 year)
研究者
María Belén Solís Chávez
Cardiac Surgery Resident
Hospital San Carlos, Madrid