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

8 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

292

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Brazylia
    • São Paulo
      • São Paulo, São Paulo, Brazylia, 04021001
        • Hospital São Paulo, Federal University of São Paulo

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Conventional Harvesting + Placebo
Patients undergoing conventional saphenous vein harvesting with simulated laser application (placebo).
Urządzenie: 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.
Procedura: 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.
Eksperymentalny: Conventional Harvesting + Photobiomodulation
Patients undergoing conventional saphenous vein harvesting with active photobiomodulation therapy applied to the surgical incision.
Procedura: 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.
Urządzenie: 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.
Komparator placebo: No-touch Harvesting + Placebo
Patients undergoing saphenous vein harvesting using the no-touch technique with simulated laser application.
Urządzenie: 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.
Procedura: 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.
Eksperymentalny: No-touch Harvesting + Photobiomodulation
Patients undergoing saphenous vein harvesting using the no-touch technique with active photobiomodulation therapy applied to the surgical incision.
Urządzenie: 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.
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of surgical wound complications at the saphenous vein harvesting site
Ramy czasowe: From postoperative hospitalization to 30 days and 3 months after surgery.
Occurance of wound infection at the surgical incision of the saphenous vein harvesting site.
From postoperative hospitalization to 30 days and 3 months after surgery.
Functional capacity assessed by the Six-Minute Walk Test
Ramy czasowe: From preoperatory assessment to postoperative day 5 or at hospital discharge, 30 days and 3 months follow-up.
Functional capacity will be evaluated using Six-Minute Walk Test to assess exercise tolerance and postoperative recovery in patients undergoing coronary artery bypass grafting.
From preoperatory assessment to postoperative day 5 or at hospital discharge, 30 days and 3 months follow-up.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Frequency and severity of adverse responses to photobiomodulation therapy
Ramy czasowe: From the first photobiomodulation therapy session until hospital discharge (Postoperative day 5 or earlier, if discharged).
Assessment of the frequency and severity of adverse reactions associated with photobiomodulation therapy during the hospital stay.
From the first photobiomodulation therapy session until hospital discharge (Postoperative day 5 or earlier, if discharged).
All-cause mortality
Ramy czasowe: Hospital discharge, 30 days after discharge and 3 months after discharge
Incidence of death from any cause following coronary artery bypass grafting.
Hospital discharge, 30 days after discharge and 3 months after discharge
Hospital readmission
Ramy czasowe: 30 days and 3 months after discharge
Incidence of hospital readmission following coronary artery bypass grafting.
30 days and 3 months after discharge
Myocardial infarction
Ramy czasowe: Perioperative, 30 days after discharge and 3 months after discharge.
Incidence of myocardial infarction following coronary artery bypass grafting.
Perioperative, 30 days after discharge and 3 months after discharge.
Length of stay in the intensive care unit (ICU)
Ramy czasowe: From date of surgery until ICU discharge (assessed up to 30 days).
Duration of stay in the intensive care unit measured in days after surgery.
From date of surgery until ICU discharge (assessed up to 30 days).
Length of hospital stay
Ramy czasowe: From hospital admission until hospital discharge (assessed up to 60 days)
Total duration of hospital stay measured in days.
From hospital admission until hospital discharge (assessed up to 60 days)
Plasma interleukin-1 (IL-1) levels
Ramy czasowe: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Assessment of plasma IL-1 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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
Ramy czasowe: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Assessment of plasma IL-6 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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
Ramy czasowe: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Assessment of plasma IL-8 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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
Ramy czasowe: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Assessment of plasma IL-10 concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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
Ramy czasowe: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Assessment of plasma TNF-α concentrations measured by enzyme-linked immunosorbent assay (ELISA).
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
Ramy czasowe: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Assessment of lipid peroxidation by measuring TBARS levels in EDTA plasma samples.
Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Protein carbonylation (CPr) levels
Ramy czasowe: Preoperative period, immediately after surgery before photobiomodulation application, 20 minutes after ICU admission, and on postoperative days 2 to 5 or until hospital discharge.
Assessment of oxidative stress through protein carbonylation analysis.
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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Sponsor

Federal University of São Paulo

Publikacje i pomocne linki

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Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

20 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 lipca 2026

Pierwszy wysłany (Rzeczywisty)

13 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 90777725.0.0000.5505

Plan dla danych uczestnika indywidualnego (IPD)

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Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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