Coronary Arterial Disease (CAD)SHIELDS-CABGNCT07068776
Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting
A study testing Shockwave treatment in people with Coronary Arterial Disease (CAD), run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Shockwave treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 3 Oct 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery, Medical University Innsbruck
Innsbruck, Tyrol, 6020
Clemens Engler, MD, PhD, +43 512 504 0, clemens.engler@i-med.ac.at
Clemens Engler, MD, PhD
About this study
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
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.
Read the detailed description
Selection of suitable grafts for coronary artery bypass grafting (CABG) is one of the most critical decisions cardiac surgeons must make. There are two main techniques for harvesting graft vessels. The first is the skeletonized harvesting technique (ST), in which only the vessel itself is dissected and isolated before removal. The second method is the "no-touch" technique (NT), where the vessel is harvested along with surrounding tissue to minimize direct manipulation and potential microtrauma to the graft.
Saphenous vein grafts (SVG) are the most commonly used conduits in CABG and can be harvested using either technique. While the NT technique has demonstrated superior long-term patency and reduced atherosclerotic changes, it is associated with a significantly higher rate of wound healing complications, which are often more severe and can have a considerable impact on patient quality of life.
Shockwave therapy (SWT) has been shown to accelerate wound healing. The SHIELDS-CABG trial employs a double-blinded, sham-controlled design to evaluate the efficacy of prophylactic SWT in reducing wound healing complications after NT saphenous vein harvesting in CABG patients. In this study, the intervention group receives SWT immediately after wound closure to enhance healing and prevent complications.
This is a prospective, single-center, single-blinded, randomized, sham-controlled trial conducted at the Department of Cardiac Surgery, Medical University of Innsbruck. Blinding is maintained intraoperatively and only applied after wound closure to avoid procedural bias. Half of the patients will receive SWT, while in the control group the device will be held over the wound for the same duration without delivering shockwaves. A double-blind design is not feasible, as the operating staff can hear the characteristic sound of the device during SWT application.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Shockwave treatment, Sham treatment
- Keywords
- Coronary artery bypass grafting, Saphenous vein graft (SVG), No-touch vein harvesting, Wound healing complications, Shockwave therapy (SWT), Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave treatmentDevice
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 treatmentDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after surgery
Secondary outcomes (9)
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.
Measured: From randomization to the end of participation at 180 days
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.
Measured: From randomization to end of study participation at 180 days
Unscheduled visits
Number of unscheduled outpatient visits
Measured: From randomization to end of study participation at 180 days
Surgical revision
Rate of surgical revisions due to wound healing complications, except for bleeding
Measured: From randomization to end of study participation at 180 days
Antibiotics due to wound healing
Proportion of patients requiring antibiotics due to wound healing complications
Measured: From randomization to end of study participation at 180 days
Discharge wound state
Wound status at discharge 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.
Measured: From randomization to discharge (Day 8±3)
Laboratory values
Difference in laboratory values:
- HbA1c
- Creatinin
- Total Cholesterol
- LDL-C
- HDL-C
- Lp(a)
- LDH,
- Erythrocytes,
- Haemoglobin
- Haematocrit
- Platelet count
- Leukocytes
- CRP,
- APTT,
- INR
- NT-pro-BNP
- Total CK
- CK-MB
- CK-MB %
- Troponin T
Measured: From randomization to end of study participation at 180 days
Adverse events
Device related adverse events A clinical trial adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in a patient or clinical trial subject C or not related to the investigational medical device. This includes events related or not to a comparator and procedures involved.
Surgical procedures themselves are not AEs; they are therapeutic measures for conditions that require surgery. The condition for which the surgery is required may be an AE. Planned surgical measures permitted by the clinical trial protocol and the condition(s) leading to these measures are not AEs, if the condition leading to the measure was present prior to inclusion into the trial.
Measured: From randomization to end of study participation at 180 days
Serious Adverse Events
Device related Serious Adverse Events
- death (excluding death from progressive disease)
- a life-threatening experience - refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe
- initial hospitalization, or prolongation of existing inpatients hospitalization
- persistent or significant disability or incapacity
- congenital anomaly or birth defect
- occur a malignant tumor
Measured: From randomization to end of study participation at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start3 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Can Gollmann-Tepeköylü, MD, PhD, Principal investigator, Department of Cardiac Surgery, Medical Univesity Innsbruck, Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068776
- Sponsor's protocol ID
- 1054/2025
- Acronym
- SHIELDS-CABG
- Status last verified
- May 2025
- First submitted
- 5 Jun 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared but may be made available upon reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07068776
- Acronym / sponsor ID
- SHIELDS-CABG / 1054/2025
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Selection of suitable grafts for coronary artery bypass grafting (CABG) is one of the most critical decisions cardiac surgeons must make. There are two main techniques for harvesting graft vessels. The first is the skeletonized harvesting technique (ST), in which only the vessel itself is dissected and isolated before removal. The second method is the "no-touch" technique (NT), where the vessel is harvested along with surrounding tissue to minimize direct manipulation and potential microtrauma to the graft.
Saphenous vein grafts (SVG) are the most commonly used conduits in CABG and can be harvested using either technique. While the NT technique has demonstrated superior long-term patency and reduced atherosclerotic changes, it is associated with a significantly higher rate of wound healing complications, which are often more severe and can have a considerable impact on patient quality of life.
Shockwave therapy (SWT) has been shown to accelerate wound healing. The SHIELDS-CABG trial employs a double-blinded, sham-controlled design to evaluate the efficacy of prophylactic SWT in reducing wound healing complications after NT saphenous vein harvesting in CABG patients. In this study, the intervention group receives SWT immediately after wound closure to enhance healing and prevent complications.
This is a prospective, single-center, single-blinded, randomized, sham-controlled trial conducted at the Department of Cardiac Surgery, Medical University of Innsbruck. Blinding is maintained intraoperatively and only applied after wound closure to avoid procedural bias. Half of the patients will receive SWT, while in the control group the device will be held over the wound for the same duration without delivering shockwaves. A double-blind design is not feasible, as the operating staff can hear the characteristic sound of the device during SWT application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: Shockwave treatmentParticipants 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. |
| Sham group | Sham comparator | Device: Sham treatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- History of venous stripping or ligation
- Uncontrolled Diabetes mellitus (HbA1c ≥ 9 %)
- Enrolled in other therapeutic or interventional trial
- Hemodynamically unstable
- Cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave treatmentThe 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 | Treatment group |
| Sham treatmentThe 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. | Device | Sham group |
Primary outcome
Wound Healing Disturbance
Time frame: 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
9 secondary outcomes
Bates-Jensen Wound Assessment Tool
Time frame: From randomization to the end of participation at 180 days
Change in EQ-5D-5L Index Score
Time frame: From randomization to end of study participation at 180 days
Unscheduled visits
Time frame: From randomization to end of study participation at 180 days
Surgical revision
Time frame: From randomization to end of study participation at 180 days
Antibiotics due to wound healing
Time frame: From randomization to end of study participation at 180 days
Discharge wound state
Time frame: From randomization to discharge (Day 8±3)
Laboratory values
Time frame: From randomization to end of study participation at 180 days
Adverse events
Time frame: From randomization to end of study participation at 180 days
Serious Adverse Events
Time frame: From randomization to end of study participation at 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared but may be made available upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Can Gollmann-Tepeköylü, MD, PhD principal investigator
Department of Cardiac Surgery, Medical Univesity Innsbruck, Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave treatment in people with Coronary Arterial Disease (CAD), run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clemens Engler, MD (+43 512 504 83659, clemens.engler@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Disturbance (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.