Photobiomodulation in Coronary Artery Bypass Grafting With No-Touch vs Conventional Saphenous Vein Harvesting. (PHOTON)
8. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
292
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Solange Guizilini, PhD
- Telefonní číslo: +55 11 982887753
- E-mail: sguizilini@unifesp.br
Studijní místa
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São Paulo
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São Paulo, São Paulo, Brazílie, 04021001
- Hospital São Paulo, Federal University of São Paulo
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: 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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Experimentální: Conventional Harvesting + Photobiomodulation
Patients undergoing conventional saphenous vein harvesting with active photobiomodulation therapy applied to the surgical incision.
|
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.
|
|
Komparátor placeba: 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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Experimentální: No-touch Harvesting + Photobiomodulation
Patients undergoing saphenous vein harvesting using the no-touch technique with active photobiomodulation therapy applied to the surgical incision.
|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of surgical wound complications at the saphenous vein harvesting site
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Frequency and severity of adverse responses to photobiomodulation therapy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. srpna 2027
Dokončení studie (Odhadovaný)
1. března 2028
Termíny zápisu do studia
První předloženo
20. března 2026
První předloženo, které splnilo kritéria kontroly kvality
8. července 2026
První zveřejněno (Aktuální)
13. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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