RecruitingNot ApplicableNCT07068776

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

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

Sponsor

Medical University Innsbruck

Enrollment

120 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Arterial Disease (CAD)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria8

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

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Interventions

DEVICEShockwave 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.

DEVICESham 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.