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NOT YET RECRUITING
NCT07699679
NA

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

Sponsor: Federal University of São Paulo

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

292

Start Date

2027-01

Completion Date

2028-03

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DEVICE

Photobiomodulation Therapy

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.

DEVICE

Sham Laser irradiation

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.

PROCEDURE

Conventional Saphenous Vein Harvesting

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.

PROCEDURE

No-Touch Saphenous Vein Harvesting

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.

Locations (1)

Hospital São Paulo, Federal University of São Paulo

São Paulo, São Paulo, Brazil