Clinical Impact of Surgical Wound Morbidity According to the Type of Saphenous Vein Harvesting Technique (Endoscopic vs. Open) in Patients Undergoing Myocardial Revascularization Surgery
Launched by HOSPITAL SAN CARLOS, MADRID · May 25, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to compare two different methods for taking a vein from the leg (called saphenous vein harvesting) that is used in heart surgeries known as coronary artery bypass grafting (CABG). One method is traditional, called open harvesting, while the other is a newer approach called endoscopic harvesting, which is less invasive and uses small incisions. The study aims to find out if the endoscopic method leads to fewer problems with wounds, shorter hospital stays, less need for antibiotics, and less pain after surgery.
To participate in this trial, patients need to be undergoing CABG surgery, either alone or along with other heart procedures, and should be between the ages of 65 to 74. Important conditions for joining include not having any recent serious heart issues or leg infections and being able to give consent for the study. If someone is eligible, they will be randomly assigned to one of the two harvesting methods and will be checked for any wound complications at discharge and through follow-up calls at one week, one month, and three months after surgery. This research will take place at the Cardiovascular Surgery Service at Hospital Clínico San Carlos.
Gender
ALL
Eligibility criteria
- 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
About Hospital San Carlos, Madrid
Hospital San Carlos, located in Madrid, is a leading healthcare institution renowned for its commitment to advancing medical research and improving patient outcomes. As a prominent clinical trial sponsor, the hospital is dedicated to conducting innovative studies that adhere to the highest ethical and scientific standards. With a multidisciplinary team of experienced researchers and clinicians, Hospital San Carlos aims to explore novel therapeutic approaches and contribute to the development of cutting-edge treatments across various medical fields. Its strategic collaborations and robust infrastructure enable the hospital to effectively facilitate clinical trials, ultimately enhancing the quality of care provided to patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported