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

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHospital San Carlos, Madrid

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergent surgery or procedures performed during cardiorespiratory arrest

Myocardial revascularization with arterial grafts only

Presence of varicose veins

History of infrainguinal vascular surgery

Trial design

Design model

Parallel

Treatments tested in this trial

Harvesting of the saphenous vein graft
Procedure/Surgery
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

Treatment groups

356 Participants

are divided into 2 treatment groups

Group A: Endoscopic saphenectomyExperimental treatment 1 intervention

Group B: Conventional and open technique for saphenous vein harvestingActive comparator 1 intervention

Trial outcomes

Primary outcomes

Wound morbidity

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. 1. Length of Hospital Stay. Unit of Measure: Days 2. Use of Antibiotics for Saphenectomy Wound Infections Measure: Number of participants requiring oral or parenteral antibiotics due to wound infection. Unit of Measure: Participants 3. 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 4. Use of Analgesics for Wound Pain Measure: Number of participants requiring analgesic treatment for saphenectomy wound pain

Time frame

From enrollment to the three-month follow-up visit

Secondary outcomes

Freedom from combined cardiac events

Freedom from death, myocardial infarction, and recurrent angina

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital San Carlos, Madrid

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: