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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Wound Healing Disturbance — 30 days after surgery 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
Trial sites (1)
Facility
City
Region
Status
Department of Cardiac Surgery, Medical University Innsbruck
Innsbruck
Tyrol
Recruiting
More Medical University Innsbruck trials in Austria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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