Shockwave therapy to improve leg wound healing after no-touch saphenous vein harvesting for coronary bypass
Official title: 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
Run by Medical University Innsbruck · NCT07068776 · Data updated 2026-11-12
This trial will test whether applying shockwave therapy to the leg incision right after no-touch saphenous vein harvesting can reduce wound healing problems in adults having coronary artery bypass grafting.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Status | Recruiting |
| Started | October 3, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | January 2029 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07068776 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) undergoing isolated CABG by median sternotomy who require two or more saphenous vein grafts harvested with the no-touch technique, are elective or urgent cases, have eGFR ≥ 15 ml/min, and can give informed consent.
✕Probably not a fit
Patients with prior venous stripping/ligation, uncontrolled diabetes (HbA1c ≥ 9%), hemodynamic instability or cardiogenic shock, emergency or salvage cases, or those enrolled in other interventional trials are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SHIELDS-CABG is a prospective, randomized, single-center, sham-controlled trial conducted at the Department of Cardiac Surgery, Medical University of Innsbruck. Adults undergoing isolated CABG who need two or more saphenous vein grafts harvested with the no-touch technique are randomized to receive a single session of shockwave therapy or a sham procedure applied to the leg wound immediately after closure. Patients are blinded to treatment allocation and followed for postoperative wound healing complications. The main aim is to compare rates and severity of wound-healing problems between the shockwave and sham groups.
Why it matters
Potential benefit: If successful, this approach could lower the rate and severity of leg wound complications after no-touch vein harvesting, leading to faster healing, fewer infections, and improved recovery.
How similar studies have gone: Shockwave therapy has shown benefit in accelerating wound healing in other settings such as chronic ulcers, but prophylactic use immediately after no-touch saphenous vein harvesting is a novel application with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Cardiac Surgery, Medical University Innsbruck
Innsbruck, Tyrol, Austria Recruiting
Study contacts
- Principal investigator: Can Gollmann-Tepeköylü, MD, PhD — Department of Cardiac Surgery, Medical Univesity Innsbruck, Innsbruck, Austria
- Study coordinator: Clemens Engler, MD
- Email: clemens.engler@i-med.ac.at
- Phone: +43 512 504 83659
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.