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NCT Number: NCT07002658

Clinical Impact of Surgical Wound Morbidity According to the Type of Saphenous Vein Harvesting Technique (Endoscopic vs. Open) in Patients Undergoing Myocardial Revascularization Surgery

The goal of this clinical trial is to compare two different techniques: endoscopic saphenous vein harvesting versus conventional open harvesting in patients undergoing coronary artery bypass grafting, either alone or in combination with another cardiac surgical procedure (valve surgery or arrhythmia surgery). The main questions the trial aims to answer are:

Does the endoscopic technique reduce surgical wound morbidity in terms of shorter hospital stays? Does endoscopic saphenous harvesting reduce the use of antibiotics for saphenectomy wound infections? Does the endoscopic technique reduce need for wound dressings due to necrosis and/or wound infection, and reduce need for analgesic treatment for wound pain? This prospective, randomized study will be conducted in the Cardiovascular Surgery Service at Hospital Clínico San Carlos.

Participants will be randomly assigned to a different saphenectomy technique. All patients will be assessed for saphenectomy wound complications upon discharge, and by phone call at 7 days, 1 month, and 3 months following the intervention.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • Pain in the leg incisions will be assessed using a standarized pain scale.
  • Antibiotic and analgesic requirements for infection or pain in the saphenous vein surgical wound will be documeted.
  • The need for outpatient treatment or hospitalization due to surgical wounds will be evaluated.
  • A surgical wound cosmetic satisfaction survey will be administered to participants.
  • Images of the saphenectomy surgical wound will be collected at 1 month postoperatively.
  • Major cardiovascular events will be monitored during follow-up visits or hospital admissions and recorded in the RECC database (local service database)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing coronary artery bypass grafting (CABG), alone or in combination with other surgery (valve or arrhythmia surgery), with or without cardiopulmonary bypass (CPB), in which preoperative evaluation includes the plan to use a short saphenous vein segment (alone or in addition to arterial conduits).
  • Availability of a surgeon or cardiac surgery resident trained in endoscopic harvesting in the operating room.
  • Patients undergoing myocardial revascularization surgeries with or without extracorporeal circulation.
  • Patients undergoing concomitant cardiac valve replacement surgery, atrial fibrillation surgery, and others, in addition to CABG

Exclusion criteria

  • Emergent surgery or procedures performed during cardiorespiratory arrest
  • Myocardial revascularization with arterial grafts only
  • Presence of varicose veins
  • History of infrainguinal vascular surgery
  • Presence of ulcers and/or active infection in the lower limbs
  • Previous stroke with neurological sequelae in the legs
  • History of deep vein thrombosis in the legs
  • Pregnancy
  • Age under 18 years
  • Lack of signed informed consent

Treatment and study plan

Harvesting of the saphenous vein graft

Procedure

Most existing studies on endoscopic saphenectomy have been conducted in CABG with cardiopulmonary bypass (CBP), whereas most CABG surgeries at the study center are performed without CBP.

The following outcomes will be identified:

  • Days of admission or need for hospitalization
  • Use of antibiotic therapy for saphenectomy wound infections
  • Need for wound dressings due to necrosis and/or wound infection
  • Need for analgesic treatment for wound pain

Primary outcomes

  1. Wound morbidity

    Time frame: From enrollment to the three-month follow-up visit

    Days of hospital stay, use of antibiotics for saphenectomy wound infections, need for wound dressings due to necrosis and/or wound infection, and need for analgesic treatment for wound pain.

    • Length of Hospital Stay. Unit of Measure: Days
    • Use of Antibiotics for Saphenectomy Wound Infections Measure: Number of participants requiring oral or parenteral antibiotics due to wound infection. Unit of Measure: Participants
    • Need for Wound Dressings Due to Necrosis and/or Infection Measure: Number of participants requiring wound dressings due to necrosis and/or wound infection. Unit of Measure: Participants
    • Use of Analgesics for Wound Pain Measure: Number of participants requiring analgesic treatment for saphenectomy wound pain

Secondary outcomes

  1. Freedom from combined cardiac events

    Time frame: 1 year

    Freedom from death, myocardial infarction, and recurrent angina

Study contacts

Contact information is provided by the study sponsor or research team.

María B Solís Chávez, MD

CONTACT

[email protected]

+34613888798

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

Endoscopic Saphenous Vein Harvesting Versus Conventional Open Harvesting in Patients Undergoing Coronary Artery Bypass Grafting, Either Alone or in Combination With Another Cardiac Surgical Procedure, in Terms of the Clinical Impact of Surgical Wound Morbidity

Acronym: EndOSiC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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