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Coronary Artery DiseasePHOTONNCT07699679

Photobiomodulation in Coronary Artery Bypass Grafting With No-Touch vs Conventional Saphenous Vein Harvesting.

A study testing Photobiomodulation Therapy, Conventional Saphenous Vein Harvesting and No-Touch Saphenous Vein Harvesting in people with Coronary Artery Disease and Coronary Artery Bypass Graft (CABG), run by Federal University of São Paulo at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This randomized, double-blind clinical trial aims to evaluate the impact of photobiomodulation therapy on postoperative outcomes in patients undergoing coronary artery bypass grafting (CABG). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Photobiomodulation Therapy, Conventional Saphenous Vein Harvesting and No-Touch Saphenous Vein Harvesting
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
292 participants
Where
1 siteBrazil
Study dates
Jan 2027to Mar 2028
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with coronary artery disease scheduled to undergo elective coronary artery bypass grafting (CABG)
  • Use of the saphenous vein as a graft for myocardial revascularization
  • Ability to understand the study procedures and provide written informed consent

Who cannot join

  • Emergency coronary artery bypass surgery
  • Previous surgery in the lower limb that prevents saphenous vein harvesting
  • Active infection at the surgical site or lower limb
  • Severe peripheral arterial disease in the lower limbs
  • Hemodynamic instability preventing study protocol procedures
  • Participation in another interventional clinical trial that may interfere with the outcomes of this study
  • Patients unable to perform postoperative functional capacity assessments
  • Individuals with highly pigmented skin or sensibility that may alter light absorption and penetration of the photobiomodulation therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Solange Guizilini, PhD contact

+55 11 982887753

sguizilini@unifesp.br

Brazil1 site
  • Hospital São Paulo, Federal University of São Paulo

    São Paulo, São Paulo, 04021001

Other trials in Brazil

About this study

Official title: Impact of Photobiomodulation in Coronary Artery Bypass Surgery: Comparison Between No-Touch and Conventional Saphenous Vein Harvesting Techniques on Clinical Outcomes, Functional Capacity, and Wound Healing: A Randomized Clinical Trial

This randomized, double-blind clinical trial aims to evaluate the impact of photobiomodulation therapy on postoperative outcomes in patients undergoing coronary artery bypass grafting (CABG). The study will compare two techniques for saphenous vein graft harvesting: the conventional technique and the no-touch technique. Participants will be randomly allocated into four groups: conventional harvesting with sham laser, conventional harvesting with photobiomodulation, no-touch harvesting with sham laser, and no-touch harvesting with photobiomodulation. The primary objective is to evaluate the effects of photobiomodulation on wound healing and postoperative complications related to the saphenous vein harvesting site. Secondary outcomes include clinical outcomes and functional capacity after surgery. The results may contribute to improving postoperative recovery and optimizing surgical strategies in patients undergoing myocardial revascularization.

Read the detailed description

Cardiovascular diseases remain one of the leading causes of morbidity and mortality worldwide. Coronary artery bypass grafting (CABG) is a widely performed surgical procedure for the treatment of advanced coronary artery disease. The saphenous vein is frequently used as a graft in CABG; however, complications related to vein harvesting, including wound infection, delayed healing, and postoperative pain, remain relevant clinical concerns.

The no-touch technique for saphenous vein harvesting has been proposed as a strategy to preserve the structural integrity of the vein and potentially improve graft patency and reduce local tissue trauma. In addition, photobiomodulation therapy (low-level laser therapy) has demonstrated beneficial effects on tissue repair, inflammation modulation, and wound healing.

This study, named PHOTON Study, is a randomized, double-blind, controlled clinical trial designed to investigate the effects of photobiomodulation therapy in patients undergoing CABG. Participants will be randomized into four groups according to the harvesting technique and the use of photobiomodulation therapy. This study protocol was developed in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines.

Photobiomodulation will be applied using a cluster laser device (E-light, DMC Equipamentos Ltda., Brazil) with a wavelength of 660 nm and output power of 100 mW. The laser will be applied locally along the surgical incision of the saphenous vein harvesting site using a point technique with standardized spacing between application points. The intervention will be performed intraoperatively and during the early postoperative period.

The primary outcomes include wound healing and postoperative complications related to the saphenous vein harvesting site. Secondary outcomes include clinical outcomes and functional capacity following surgery.

This trial may contribute to improving postoperative care and recovery in patients undergoing coronary artery bypass grafting.

Being tested
Photobiomodulation Therapy, Sham Laser irradiation, Conventional Saphenous Vein Harvesting, No-Touch Saphenous Vein Harvesting
Keywords
Photobiomodulation, Low-Level Laser Therapy, Coronary Artery Bypass Grafting, Saphenous Vein Harvesting, No-Touch Technique, Wound Healing
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photobiomodulation TherapyDevice

    Photobiomodulation will be applied using a cluster laser device (E-light, DMC Equipamentos Ltda., Brazil) with wavelength of 660 nm and output power of 100 mW. The therapy will be applied along the surgical incision of the saphenous vein harvesting site using a point technique with standardized spacing between application points. The intervention will be performed intraoperatively and during the early postoperative period.

  • Sham Laser irradiationDevice

    Simulated photobiomodulation therapy applied using the same laser device without emission of therapeutic laser energy. This sham procedure is used to maintain blinding of participants and outcome assessors.

  • Conventional Saphenous Vein HarvestingProcedure or surgery

    Conventional Saphenous Vein Harvesting refers to the traditional open surgical technique used to obtain the great saphenous vein for grafting procedures, most commonly in coronary artery bypass grafting (CABG). The procedure involves a continuous longitudinal incision along the course of the vein in the lower limb, allowing direct visualization and careful dissection of the vessel from surrounding tissues. Side branches are ligated or clipped, and the harvested vein is subsequently prepared for use as a vascular graft. The technique is performed under sterile surgical conditions by qualified surgeons.

  • No-Touch Saphenous Vein HarvestingProcedure or surgery

    No-Touch Saphenous Vein Harvesting refers to a surgical technique for harvesting the great saphenous vein in which the vein is removed together with a pedicle of surrounding perivascular tissue, avoiding direct manual manipulation and excessive distension of the vessel. The procedure is performed through an open incision under sterile conditions, preserving the vein's adventitia, vasa vasorum, and surrounding connective tissue in order to minimize endothelial injury and maintain vascular integrity. Side branches are carefully ligated or clipped, and the harvested graft is prepared according to institutional surgical protocols for subsequent use in vascular or coronary artery bypass procedures.

Study groups in NCT07699679
Study groupRoleWhat they receive
Conventional Harvesting + Sham laserSham comparatorPatients undergoing conventional saphenous vein harvesting with simulated laser application (sham).
Receives: Device: Sham Laser irradiation; Procedure: Conventional Saphenous Vein Harvesting
Conventional Harvesting + PhotobiomodulationExperimentalPatients undergoing conventional saphenous vein harvesting with active photobiomodulation therapy applied to the surgical incision.
Receives: Device: Photobiomodulation Therapy; Procedure: Conventional Saphenous Vein Harvesting
No-touch Harvesting + Sham laserSham comparatorPatients undergoing saphenous vein harvesting using the no-touch technique with simulated laser application.
Receives: Device: Sham Laser irradiation; Procedure: No-Touch Saphenous Vein Harvesting
No-touch Harvesting + PhotobiomodulationExperimentalPatients undergoing saphenous vein harvesting using the no-touch technique with active photobiomodulation therapy applied to the surgical incision.
Receives: Device: Photobiomodulation Therapy; Procedure: No-Touch Saphenous Vein Harvesting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of surgical wound complications at the saphenous vein harvesting site

    Occurance of one or more surgical wound complications at the saphenous vein harvesting site, including wound infection, necrosis, wound dehiscence, wound drainage or fluid accumulation.

    Measured: From postoperative hospitalization to 30 days and 3 months after surgery.

Secondary outcomes (14)
  1. Frequency and severity of adverse responses to photobiomodulation therapy

    Assessment of the frequency and severity of adverse reactions associated with photobiomodulation therapy during the hospital stay.

    Measured: From the first photobiomodulation therapy session until hospital discharge (Postoperative day 5 or earlier, if discharged).

  2. All-cause mortality

    Incidence of death from any cause following coronary artery bypass grafting.

    Measured: Hospital discharge, 30 days after discharge and 3 months after discharge

  3. Hospital readmission

    Incidence of hospital readmission following coronary artery bypass grafting.

    Measured: 30 days and 3 months after discharge

  4. Myocardial infarction

    Incidence of myocardial infarction following coronary artery bypass grafting.

    Measured: Perioperative, 30 days after discharge and 3 months after discharge.

  5. Length of stay in the intensive care unit (ICU)

    Duration of stay in the intensive care unit measured in days after surgery.

    Measured: From date of surgery until ICU discharge (assessed up to 30 days).

  6. Length of hospital stay

    Total duration of hospital stay measured in days.

    Measured: From hospital admission until hospital discharge (assessed up to 60 days)

  7. Plasma interleukin-1 (IL-1) levels

    Assessment of plasma IL-1 concentrations measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.

  8. Plasma interleukin-6 (IL-6) levels

    Assessment of plasma IL-6 concentrations measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.

  9. Plasma interleukin-8 (IL-8) levels

    Assessment of plasma IL-8 concentrations measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.

  10. Plasma interleukin-10 (IL-10) levels

    Assessment of plasma IL-10 concentrations measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.

  11. Plasma tumor necrosis factor-alpha (TNF-α) levels

    Assessment of plasma TNF-α concentrations measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.

  12. Thiobarbituric acid reactive substances (TBARS) levels

    Assessment of lipid peroxidation by measuring TBARS levels in EDTA plasma samples.

    Measured: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.

  13. Protein carbonylation (CPr) levels

    Assessment of oxidative stress through protein carbonylation analysis.

    Measured: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.

  14. Functional capacity assessed by the Six-Minute Walk Test

    Functional capacity will be evaluated using Six-Minute Walk Test to assess exercise tolerance and postoperative recovery in patients undergoing coronary artery bypass grafting.

    Measured: One day before surgery, five days after surgery, 30 days after hospital discharge and 3 months after discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to four parallel groups according to the saphenous vein harvesting technique and the use of photobiomodulation therapy: conventional harvesting with sham laser, conventional harvesting with photobiomodulation, no-touch harvesting with sham laser, and no-touch harvesting with photobiomodulation.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
292 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699679
Sponsor's protocol ID
90777725.0.0000.5505
Acronym
PHOTON
Status last verified
Oct 2026
First submitted
20 Mar 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Photobiomodulation Therapy, Conventional Saphenous Vein Harvesting and No-Touch Saphenous Vein Harvesting in people with Coronary Artery Disease and Coronary Artery Bypass Graft (CABG), run by Federal University of São Paulo at 1 site in Brazil.

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 3 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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 Brazil. 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 Solange Guizilini, PhD (+55 11 982887753, sguizilini@unifesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of surgical wound complications at the saphenous vein harvesting site (time frame: From postoperative hospitalization to 30 days and 3 months 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 7 Oct 2026.

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PHOTON Clinical Trial NCT07699679 | AzTrials