Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting: A Prospective, Single-Center, Single-Blind, Randomized, Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Wound Healing Disturbance
研究概览
简要总结
The aim of this trial is to apply shockwaves to the leg wound after saphenous vein harvesting and closure in order to reduce the occurrence of postoperative wound healing complications following coronary artery bypass grafting using venous grafts.
详细描述
Selection of suitable grafts for coronary artery bypass grafting (CABG) is one of the most critical decisions cardiac surgeons must make. There are two main techniques for harvesting graft vessels. The first is the skeletonized harvesting technique (ST), in which only the vessel itself is dissected and isolated before removal. The second method is the "no-touch" technique (NT), where the vessel is harvested along with surrounding tissue to minimize direct manipulation and potential microtrauma to the graft.
Saphenous vein grafts (SVG) are the most commonly used conduits in CABG and can be harvested using either technique. While the NT technique has demonstrated superior long-term patency and reduced atherosclerotic changes, it is associated with a significantly higher rate of wound healing complications, which are often more severe and can have a considerable impact on patient quality of life.
Shockwave therapy (SWT) has been shown to accelerate wound healing. The SHIELDS-CABG trial employs a double-blinded, sham-controlled design to evaluate the efficacy of prophylactic SWT in reducing wound healing complications after NT saphenous vein harvesting in CABG patients. In this study, the intervention group receives SWT immediately after wound closure to enhance healing and prevent complications.
This is a prospective, single-center, single-blinded, randomized, sham-controlled trial conducted at the Department of Cardiac Surgery, Medical University of Innsbruck. Blinding is maintained intraoperatively and only applied after wound closure to avoid procedural bias. Half of the patients will receive SWT, while in the control group the device will be held over the wound for the same duration without delivering shockwaves. A double-blind design is not feasible, as the operating staff can hear the characteristic sound of the device during SWT application.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Male or female patients > 18 years
- •Isolated CABG procedure in the need of 2 or more venous grafts
- •Elective or urgent cases
- •Median sternotomy approach
- •eGFR ≥ 15 ml/min
- •Willing to participate in trial
- •Able to provide informed consent
排除标准
- •History of venous stripping or ligation
- •Uncontrolled Diabetes mellitus (HbA1c ≥ 9 %)
- •Enrolled in other therapeutic or interventional trial
- •Hemodynamically unstable
- •Cardiogenic shock
- •Any condition that seriously increases the risk of noncompliance or loss of follow-up
- •Emergency case
- •Salvage case
结局指标
主要结局
Wound Healing Disturbance
时间窗: 30 days after surgery
We defined the occurrence of a wound healing complication as followed: Definition of Surgical Site Infection (SSI) The SSI definition is in accordance with the guidelines of the center for disease control and their recommendations for superficial incisional SSI: * Date of event occurs within 30 days following the operative procedure AND involves only skin and subcutaneous tissue of the incision AND * Patient has at least one of the following: * Purulent drainage from the superficial incision * Organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment * Superficial incision that is deliberately opened by a sur
次要结局
- Surgical revision(From randomization to end of study participation at 180 days)
- Laboratory values(From randomization to end of study participation at 180 days)
- Adverse events(From randomization to end of study participation at 180 days)
- Bates-Jensen Wound Assessment Tool(From randomization to the end of participation at 180 days)
- Discharge wound state(From randomization to discharge (Day 8±3))
- Change in EQ-5D-5L Index Score(From randomization to end of study participation at 180 days)
- Unscheduled visits(From randomization to end of study participation at 180 days)
- Antibiotics due to wound healing(From randomization to end of study participation at 180 days)
- Serious Adverse Events(From randomization to end of study participation at 180 days)