Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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