Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting (SHIELDS-CABG)

Medical University Innsbruck

Status: Enrolling

Conditions: Coronary Arterial Disease (CAD)

Treatments: Device: Shockwave treatment; Device: Sham treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07068776

1054/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

Participants in this arm receive intraoperative shockwave therapy (SWT) applied to the leg wound after saphenous vein harvesting and wound closure. Shockwaves are administered during the reperfusion phase while the patient is still on cardiopulmonary bypass. The applicator is moved in circular motion over the wound using a sterile cover and ultrasound gel. The energy settings are 0.1 mJ/mm² at 5 Hz, with 25 impulses per centimeter of wound length. This intervention aims to reduce postoperative wound healing complications.

Treatment:

Device: Shockwave treatment

Sham group

Sham Comparator group

Description:

Participants in this arm receive a sham treatment mimicking the active shockwave therapy. The applicator is moved over the leg wound in the same sterile manner using ultrasound gel and sterile cover, but no shockwaves are emitted. The procedure takes the same amount of time and follows the same protocol.

Treatment:

Device: Sham treatment