Last updated 23 days ago

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

292 patients around the world
Available in Brazil
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.
Federal University of São Paulo
1Research sites
292Patients around the world

This study is for people with

Coronary disease
Coronary Artery Disease

Requirements for the patient

To 75 Years
All Gender

Medical requirements

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.
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.

Sites

Hospital São Lucas - SP
Av. Anna Costa, 168 - Vila Mathias, Santos - SP, 11060-905, Brazil
LinkedinInstagramFacebook
Terms and ConditionsPrivacy Policy