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

NCT07068776 | Recruiting

• 1 other identifier: 1054/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Arterial Disease (CAD)

Keywords

Coronary artery bypass grafting; Saphenous vein graft (SVG); No-touch vein harvesting; Wound healing complications; Shockwave therapy (SWT); Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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

  30 days after surgery

Secondary Outcomes (9)

• Bates-Jensen Wound Assessment Tool

  From randomization to the end of participation at 180 days

• Change in EQ-5D-5L Index Score

  From randomization to end of study participation at 180 days

• Unscheduled visits

  From randomization to end of study participation at 180 days

• Surgical revision

  From randomization to end of study participation at 180 days

• Antibiotics due to wound healing

  From randomization to end of study participation at 180 days

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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.

Device: Shockwave treatment

Sham group

SHAM COMPARATOR

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.

Device: Sham treatment

Interventions

Sham treatment DEVICE

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.

Sham group

Shockwave treatment DEVICE

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.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Cardiac Surgery, Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Study Officials

• Can Gollmann-Tepeköylü, MD, PhD

  Department of Cardiac Surgery, Medical Univesity Innsbruck, Innsbruck, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clemens Engler, MD

CONTACT

+43 512 504 83659; clemens.engler@i-med.ac.at

Can Gollmann-Tepeköylü, MD, PhD

CONTACT

+43 512 504 80466; can.gt@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 16, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)