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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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)

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Harvesting of the saphenous vein graft	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

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-06-03
• Last updated: 2025-06-06

Locations

1 site across 1 country: Spain