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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

Department of Cardiac Surgery, Medical University Innsbruck
Innsbruck, Tyrol, Austria