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

NCT07699679 | Not Yet Recruiting DMC

• 1 other identifier: 90777725.0.0000.5505
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Graft (CABG); Surgical Wound Healing

Keywords

Photobiomodulation; Low-Level Laser Therapy; Coronary Artery Bypass Grafting; Saphenous Vein Harvesting; No-Touch Technique; Wound Healing

Outcome Measures

Primary Outcomes (2)

• Incidence of surgical wound complications at the saphenous vein harvesting site

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

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

• 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.

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

Secondary Outcomes (13)

• Frequency and severity of adverse responses to photobiomodulation therapy

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

• All-cause mortality

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

• Hospital readmission

  30 days and 3 months after discharge

• Myocardial infarction

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

• Length of stay in the intensive care unit (ICU)

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

Study Arms (4)

Conventional Harvesting + Placebo

PLACEBO COMPARATOR

Patients undergoing conventional saphenous vein harvesting with simulated laser application (placebo).

Device: Placebo Laser; Procedure: Conventional Saphenous Vein Harvesting

Conventional Harvesting + Photobiomodulation

EXPERIMENTAL

Patients undergoing conventional saphenous vein harvesting with active photobiomodulation therapy applied to the surgical incision.

Device: Photobiomodulation Therapy; Procedure: Conventional Saphenous Vein Harvesting

No-touch Harvesting + Placebo

PLACEBO COMPARATOR

Patients undergoing saphenous vein harvesting using the no-touch technique with simulated laser application.

Device: Placebo Laser; Procedure: No-Touch Saphenous Vein Harvesting

No-touch Harvesting + Photobiomodulation

EXPERIMENTAL

Patients undergoing saphenous vein harvesting using the no-touch technique with active photobiomodulation therapy applied to the surgical incision.

Device: Photobiomodulation Therapy; Procedure: No-Touch Saphenous Vein Harvesting

Interventions

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.

Conventional Harvesting + Photobiomodulation; No-touch Harvesting + Photobiomodulation

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 Harvesting + Placebo; No-touch Harvesting + Placebo

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.

Conventional Harvesting + Photobiomodulation; Conventional Harvesting + Placebo

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.

No-touch Harvesting + Photobiomodulation; No-touch Harvesting + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital São Paulo, Federal University of São Paulo

São Paulo, São Paulo, 04021001, Brazil

Location

Related Links

• No-touch technique for saphenous vein graft harvesting in coronary artery bypass surgery safely improves graft patency: a meta-analysis of randomized controlled trials.
• Oxygen uptake on-kinetics during six-minute walk test predicts short-term outcomes after off-pump coronary artery bypass surgery.
• Effectiveness of low-intensity laser therapy on tissue repair following saphenectomy in patients who underwent coronary artery bypass graft: A randomized, double-blind study.
• SUPERIOR SVG: no touch saphenous harvesting to improve patency following coronary bypass grafting (a multi-Centre randomized control trial, NCT01047449).
• Pedicled no-touch saphenous vein graft harvest limits vascular smooth muscle cell activation: the PATENT saphenous vein graft study.
• Detection and quantification of cytokines and other biomarkers.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Solange Guizilini, PhD

CONTACT

+55 11 982887753; sguizilini@unifesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. Photobiomodulation therapy and placebo procedures will be performed using the same device to ensure that participants cannot distinguish between active and simulated treatment. The laser device will be handled by a trained researcher not involved in outcome assessment. Surgeons responsible for the vein harvesting technique will not participate in postoperative evaluations to maintain blinding of the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 placebo, conventional harvesting with photobiomodulation, no-touch harvesting with placebo, and no-touch harvesting with photobiomodulation.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

BR (1)