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.
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
History of venous stripping or ligation
Uncontrolled Diabetes mellitus (HbA1c ≥ 9 %)
Enrolled in other therapeutic or interventional trial
Hemodynamically unstable
Parallel
Shockwave treatment
DeviceThe 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
DeviceThe 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.
Wound Healing Disturbance
We defined the occurrence of a wound healing complication as followed: Definition of Surgical Site Infection (SSI) The SSI definition is in accordance with the guidelines of the center for disease control and their recommendations for superficial incisional SSI: * Date of event occurs within 30 days following the operative procedure AND involves only skin and subcutaneous tissue of the incision AND * Patient has at least one of the following: * Purulent drainage from the superficial incision * Organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment * Superficial incision that is deliberately opened by a sur
Bates-Jensen Wound Assessment Tool
Difference in the Bates-Jensen Wound Assessment Tool (BWAT) score. The BWAT is a validated instrument used to assess wound healing, consisting of 13 scored items related to wound size, depth, edges, undermining, necrotic tissue, exudate, skin color, peripheral tissue, granulation, and epithelialization. Each item is scored from 1 (best) to 5 (worst). The total score ranges from 13 (completely healed wound) to 65 (most severe wound condition). Higher scores indicate worse wound status.
Change in EQ-5D-5L Index Score
Difference in the EQ-5D-5L index score, a standardized measure of health-related quality of life developed by the EuroQol Group. The EQ-5D-5L index score ranges from -0.594 to 1.000, where higher scores indicate better health status. A score of 1 represents full health, 0 represents a health state equivalent to death, and negative values represent health states considered worse than death.
Unscheduled visits
Number of unscheduled outpatient visits
Surgical revision
Rate of surgical revisions due to wound healing complications, except for bleeding
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