Comparing two surgical techniques for vein extraction in heart surgery
Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting, a Randomized Non-inferiority Clinical Trial
This study is testing whether a new way of removing a vein for heart surgery causes fewer problems than the traditional method for patients having coronary bypass surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Cirugia Cardiaca, Uruguay Academic / other |
| Locations | 1 site (Montevideo) |
| Trial ID | NCT06496321 on ClinicalTrials.gov |
What this trial studies
This clinical research project aims to compare the morbidity associated with two surgical techniques for extracting the internal saphenous vein used in coronary artery bypass grafting. The study will evaluate the conventional saphenectomy technique against the no-touch saphenectomy technique, which has shown promising results in previous trials. A prospective randomized clinical trial will be conducted to assess various morbidity factors, including local infection and wound complications, in patients undergoing coronary revascularization. The goal is to demonstrate that the no-touch technique is not inferior to the conventional method in terms of wound morbidity.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for coronary revascularization surgery requiring the internal saphenous vein as a conduit.
Not a fit: Patients undergoing emergency surgeries or those with poor metabolic control or chronic venous insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing coronary artery bypass grafting.
How similar studies have performed: Previous studies have indicated positive outcomes for the no-touch saphenectomy technique, suggesting potential for success in this comparative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit. Exclusion Criteria: * Emergency surgeries. * Poor metabolic control (HbA1c \> 6.5%). * Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs. * Type II obesity (BMI\>35).
Where this trial is running
Montevideo
- Instituto Nacional de Cirugia Cardiaca — Montevideo, Uruguay (Recruiting)
Study contacts
- Principal investigator: Juan A Montero, MD — Instituto Nacional de Cirugía Cardíaca
- Study coordinator: Juan A Montero, MD
- Email: juani.montero94@gmail.com
- Phone: +59899428604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.