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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство Placebo Laser
  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.
• Процедура 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
• Процедура 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 integri

Первичные конечные точки

• Incidence of surgical wound complications at the saphenous vein harvesting site [Срок оценки: From postoperative hospitalization to 30 days and 3 months after surgery.]
• Functional capacity assessed by the Six-Minute Walk Test [Срок оценки: From preoperatory assessment to postoperative day 5 or at hospital discharge, 30 days and 3 months follow-up.]

Вторичные конечные точки (12)

• Frequency and severity of adverse responses to photobiomodulation therapy [Срок оценки: From the first photobiomodulation therapy session until hospital discharge (Postoperative day 5 or earlier, if discharged).]
• All-cause mortality [Срок оценки: Hospital discharge, 30 days after discharge and 3 months after discharge]
• Hospital readmission [Срок оценки: 30 days and 3 months after discharge]
• Myocardial infarction [Срок оценки: Perioperative, 30 days after discharge and 3 months after discharge.]
• Length of stay in the intensive care unit (ICU) [Срок оценки: From date of surgery until ICU discharge (assessed up to 30 days).]
• Length of hospital stay [Срок оценки: From hospital admission until hospital discharge (assessed up to 60 days)]
• Plasma interleukin-1 (IL-1) levels [Срок оценки: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.]
• Plasma interleukin-6 (IL-6) levels [Срок оценки: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.]
• Plasma interleukin-8 (IL-8) levels [Срок оценки: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.]
• Plasma interleukin-10 (IL-10) levels [Срок оценки: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.]
• Plasma tumor necrosis factor-alpha (TNF-α) levels [Срок оценки: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.]
• Thiobarbituric acid reactive substances (TBARS) levels [Срок оценки: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital São Paulo, Federal University of São Paulo — São Paulo

Идентификаторы

NCT: NCT07699679 · 90777725.0.0000.5505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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