Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting
NCT ID: NCT07068776
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-10-03
2029-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment group
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.
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.
Sham group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Principal Investigators
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Can Gollmann-Tepeköylü, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiac Surgery, Medical Univesity Innsbruck, Innsbruck, Austria
Locations
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Department of Cardiac Surgery, Medical University Innsbruck
Innsbruck, Tyrol, Austria
Countries
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Central Contacts
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Facility Contacts
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Clemens Engler, MD, PhD
Role: primary
Other Identifiers
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1054/2025
Identifier Type: -
Identifier Source: org_study_id