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.
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
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
Parallel
Photobiomodulation Therapy
DevicePhotobiomodulation 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 irradiation
DeviceSimulated 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 Harvesting
Procedure/SurgeryConventional 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/SurgeryNo-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.
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.
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.
All-cause mortality
Incidence of death from any cause following coronary artery bypass grafting.
Hospital readmission
Incidence of hospital readmission following coronary artery bypass grafting.
Myocardial infarction
Incidence of myocardial infarction following coronary artery bypass grafting.
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