Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shockwave treatment, Sham treatment.
- Who it may be relevant to
- Registry conditions: Coronary Arterial Disease (CAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Detailed 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.
Interventions
- Device Shockwave treatment
The shockwave device will be set to an energy flux density of 0.1 mJ/mm² at 5 Hz, with approximately 25 impulses per centimeter of wound length. This means that one centimeter of the wound will be treated for 5 seconds. The shockwave treatment will then be carried out, with each centimeter of the wound area treated for 5 seconds using gentle circular motions. - Device Sham treatment
The applicator will not be connected to the shockwave device. The applicator treatment will then be carried out, with each centimeter of the wound area treated for 5 seconds using gentle circular motions.
Primary outcome measures
- Wound Healing Disturbance [Time frame: 30 days after surgery]
Secondary outcome measures (9)
- Bates-Jensen Wound Assessment Tool [Time frame: From randomization to the end of participation at 180 days]
- Change in EQ-5D-5L Index Score [Time frame: From randomization to end of study participation at 180 days]
- Unscheduled visits [Time frame: From randomization to end of study participation at 180 days]
- Surgical revision [Time frame: From randomization to end of study participation at 180 days]
- Antibiotics due to wound healing [Time frame: From randomization to end of study participation at 180 days]
- Discharge wound state [Time frame: From randomization to discharge (Day 8±3)]
- Laboratory values [Time frame: From randomization to end of study participation at 180 days]
- Adverse events [Time frame: From randomization to end of study participation at 180 days]
- Serious Adverse Events [Time frame: From randomization to end of study participation at 180 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Austria · 1 center
- Department of Cardiac Surgery, Medical University Innsbruck — Innsbruck
Identifiers
NCT: NCT07068776 · 1054/2025