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

8 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

292

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Conventional Harvesting + Placebo
Patients undergoing conventional saphenous vein harvesting with simulated laser application (placebo).
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.
Comparatore placebo: No-touch Harvesting + Placebo
Patients undergoing saphenous vein harvesting using the no-touch technique with simulated laser application.
Dispositivo: 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.
Sperimentale: No-touch Harvesting + Photobiomodulation
Patients undergoing saphenous vein harvesting using the no-touch technique with active photobiomodulation therapy applied to the surgical incision.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of surgical wound complications at the saphenous vein harvesting site
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frequency and severity of adverse responses to photobiomodulation therapy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Federal University of São Paulo

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 marzo 2028

Date di iscrizione allo studio

Primo inviato

20 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 90777725.0.0000.5505

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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