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NCT Number: NCT07699679

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

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 placebo, conventional harvesting with photobiomodulation, no-touch harvesting with placebo, 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Bypass Graft (CABG) Coronary Disease Heart Diseases Myocardial Ischemia Surgical Wound Healing Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital São Paulo, Federal University of São Paulo

São Paulo, 04021001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

photobiomodulation therapy

Device

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.

Placebo Laser

Device

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

Conventional Saphenous Vein Harvesting

Procedure

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 Harvesting

Procedure

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.

Primary outcomes

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

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

    Occurance of wound infection at the surgical incision of the saphenous vein harvesting site.

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

    Time frame: From preoperatory assessment to postoperative day 5 or at hospital discharge, 30 days and 3 months follow-up.

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

Secondary outcomes

  1. Frequency and severity of adverse responses to photobiomodulation therapy

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

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

  2. All-cause mortality

    Time frame: Hospital discharge, 30 days after discharge and 3 months after discharge

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

  3. Hospital readmission

    Time frame: 30 days and 3 months after discharge

    Incidence of hospital readmission following coronary artery bypass grafting.

  4. Myocardial infarction

    Time frame: Perioperative, 30 days after discharge and 3 months after discharge.

    Incidence of myocardial infarction following coronary artery bypass grafting.

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

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

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

  6. Length of hospital stay

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

    Total duration of hospital stay measured in days.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  12. Thiobarbituric acid reactive substances (TBARS) levels

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

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

  13. Protein carbonylation (CPr) levels

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

    Assessment of oxidative stress through protein carbonylation analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Solange Guizilini, PhD

CONTACT

[email protected]

+55 11 982887753

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study 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

Acronym: PHOTON

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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