Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstituto Nacional de Cirugia Cardiaca, Uruguay
About this trial
A clinical research project will be carried out that will consist of a non-inferiority study. The objective is to compare the morbidity of two different surgical techniques for the extraction of the internal saphenous vein, intended to be used as a conduit in coronary bypass.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.
Disqualifiers
Emergency surgeries.
Poor metabolic control (HbA1c > 6.5%).
Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.
Type II obesity (BMI>35).
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Saphenous vein harvest
Procedure/SurgeryThe conventional one involves harvesting only the vein, without perivascular tissue or the nerve.
No touch Saphenous vein harvest
Procedure/SurgeryDuring the extraction of the saphenous vein using the "no touch" technique, it is sectioned with the perivascular adipose tissue and the saphenous nerve of the leg.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: ConventionalExperimental treatment 1 intervention
Group B: No TouchExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity.
Our primary objective will be to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence.
Time frame
1 week, 1 month, 6 monthsSecondary outcomes
1
Incidence of local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times.
Find the incidence of each of the study factors: local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times.
Time frame
1 week, 1 month, 6 monthsOther outcomes
1
Saphenous vein bypass patency
Patients will be offered computed tomography angiography one year after surgery to evaluate graft patency.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov