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

San Carlos Clinical Hospital

Status: Not yet enrolling

Conditions: Cardiac Surgery; CABG-patients; Wound Complications; Saphenectomy; Off Pump Coronary Artery Bypass Graft; Antibiotic Use; Coronary Artery Bypass Graft With or Without ECC; Endoscopic Surgery

Treatments: Procedure: Harvesting of the saphenous vein graft

Study type: Interventional

Funder types: Other

Identifiers

NCT07002658

25/148-E

Details and patient eligibility

About

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.

Full description

• 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)

Enrollment: 356 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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356 participants in 2 patient groups

Endoscopic saphenectomy

Experimental group

Description:

Endoscopic vein harvesting in CABG surgery requiring a vein graft with or without extracorporeal circulation

Treatment:

Procedure: Harvesting of the saphenous vein graft

Conventional and open technique for saphenous vein harvesting

Active Comparator group

Description:

Using the conventional open technique for harvesting the saphenous vein in any type of surgery with or without extracorporeal circulation

Treatment:

Procedure: Harvesting of the saphenous vein graft