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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-08-01

Brief Summary

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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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Detailed Description

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* 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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group will receive the open technique for saphenous vein harvesting and the other group will receive the endoscopic technique.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Endoscopic saphenectomy

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

Group Type EXPERIMENTAL

Harvesting of the saphenous vein graft

Intervention Type 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

Conventional and open technique for saphenous vein harvesting

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

Group Type ACTIVE_COMPARATOR

Harvesting of the saphenous vein graft

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No