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

2026년 7월 8일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

292

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Conventional Harvesting + Placebo
Patients undergoing conventional saphenous vein harvesting with simulated laser application (placebo).
장치: 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.
절차: 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.
실험적: Conventional Harvesting + Photobiomodulation
Patients undergoing conventional saphenous vein harvesting with active photobiomodulation therapy applied to the surgical incision.
절차: 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.
장치: 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.
위약 비교기: No-touch Harvesting + Placebo
Patients undergoing saphenous vein harvesting using the no-touch technique with simulated laser application.
장치: 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.
절차: 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.
실험적: No-touch Harvesting + Photobiomodulation
Patients undergoing saphenous vein harvesting using the no-touch technique with active photobiomodulation therapy applied to the surgical incision.
장치: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of surgical wound complications at the saphenous vein harvesting site
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Frequency and severity of adverse responses to photobiomodulation therapy
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Federal University of São Paulo

간행물 및 유용한 링크

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유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2028년 3월 1일

연구 등록 날짜

최초 제출

2026년 3월 20일

QC 기준을 충족하는 최초 제출

2026년 7월 8일

처음 게시됨 (실제)

2026년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 8일

마지막으로 확인됨

2026년 7월 1일

추가 정보

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키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 90777725.0.0000.5505

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위치

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