Photobiomodulation in Coronary Artery Bypass Grafting With No-Touch vs Conventional Saphenous Vein Harvesting. (PHOTON)
2026年7月8日 更新者：Solange Guizilini、Federal University of São Paulo
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
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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
292
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Solange Guizilini, PhD
- 电话号码：+55 11 982887753
- 邮箱：sguizilini@unifesp.br
学习地点
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São Paulo
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São Paulo、São Paulo、巴西、04021001
- Hospital São Paulo, Federal University of São Paulo
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Conventional Harvesting + Placebo
Patients undergoing conventional saphenous vein harvesting with simulated laser application (placebo).
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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 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.
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实验性的：Conventional Harvesting + Photobiomodulation
Patients undergoing conventional saphenous vein harvesting with active photobiomodulation therapy applied to the surgical incision.
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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.
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.
|
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安慰剂比较：No-touch Harvesting + Placebo
Patients undergoing saphenous vein harvesting using the no-touch technique with simulated laser application.
|
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.
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.
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实验性的：No-touch Harvesting + Photobiomodulation
Patients undergoing saphenous vein harvesting using the no-touch technique with active photobiomodulation therapy applied to the surgical incision.
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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.
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of surgical wound complications at the saphenous vein harvesting site
大体时间：From postoperative hospitalization to 30 days and 3 months after surgery.
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Occurance of wound infection at the surgical incision of the saphenous vein harvesting site.
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From postoperative hospitalization to 30 days and 3 months after surgery.
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Functional capacity assessed by the Six-Minute Walk Test
大体时间：From preoperatory assessment to postoperative day 5 or at hospital discharge, 30 days and 3 months follow-up.
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Functional capacity will be evaluated using Six-Minute Walk Test to assess exercise tolerance and postoperative recovery in patients undergoing coronary artery bypass grafting.
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From preoperatory assessment to postoperative day 5 or at hospital discharge, 30 days and 3 months follow-up.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency and severity of adverse responses to photobiomodulation therapy
大体时间：From the first photobiomodulation therapy session until hospital discharge (Postoperative day 5 or earlier, if discharged).
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Assessment of the frequency and severity of adverse reactions associated with photobiomodulation therapy during the hospital stay.
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From the first photobiomodulation therapy session until hospital discharge (Postoperative day 5 or earlier, if discharged).
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All-cause mortality
大体时间：Hospital discharge, 30 days after discharge and 3 months after discharge
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Incidence of death from any cause following coronary artery bypass grafting.
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Hospital discharge, 30 days after discharge and 3 months after discharge
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Hospital readmission
大体时间：30 days and 3 months after discharge
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Incidence of hospital readmission following coronary artery bypass grafting.
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30 days and 3 months after discharge
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Myocardial infarction
大体时间：Perioperative, 30 days after discharge and 3 months after discharge.
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Incidence of myocardial infarction following coronary artery bypass grafting.
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Perioperative, 30 days after discharge and 3 months after discharge.
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Length of stay in the intensive care unit (ICU)
大体时间：From date of surgery until ICU discharge (assessed up to 30 days).
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Duration of stay in the intensive care unit measured in days after surgery.
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From date of surgery until ICU discharge (assessed up to 30 days).
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Length of hospital stay
大体时间：From hospital admission until hospital discharge (assessed up to 60 days)
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Total duration of hospital stay measured in days.
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From hospital admission until hospital discharge (assessed up to 60 days)
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Plasma interleukin-1 (IL-1) levels
大体时间：Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Assessment of plasma IL-1 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Plasma interleukin-6 (IL-6) levels
大体时间：Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Assessment of plasma IL-6 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Plasma interleukin-8 (IL-8) levels
大体时间：Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Assessment of plasma IL-8 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Plasma interleukin-10 (IL-10) levels
大体时间：Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Assessment of plasma IL-10 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Plasma tumor necrosis factor-alpha (TNF-α) levels
大体时间：Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Assessment of plasma TNF-α concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Thiobarbituric acid reactive substances (TBARS) levels
大体时间：Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Assessment of lipid peroxidation by measuring TBARS levels in EDTA plasma samples.
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Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Protein carbonylation (CPr) levels
大体时间：Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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Assessment of oxidative stress through protein carbonylation analysis.
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Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年8月1日
研究完成 (估计的)
2028年3月1日
研究注册日期
首次提交
2026年3月20日
首先提交符合 QC 标准的
2026年7月8日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月8日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.