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Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.

Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting, a Randomized Non-inferiority Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06496321
Acronym
TNT
Enrollment
52
Registered
2024-07-11
Start date
2024-03-15
Completion date
2025-12-31
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Artery Disease, No Touch, Saphenectomy, Wound Complication

Keywords

Saphenectomy, No Touch, Coronary Artery Disease

Brief summary

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.

Detailed description

Current clinical trials have shown that the no-touch saphenectomy technique has had a positive impact on the short- and long-term patency of coronary bypass, compared to the conventional extraction technique. It is important to highlight that the conventional technique is the most used in our country (Uruguay, South America), while the no touch has fallen into disuse. Given this disparity in the application of the techniques, it is considered essential to compare both methods in terms of morbidity. For this purpose, a prospective randomized clinical trial will be carried out. The primary objective is 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. The investigators will seek to achieve as a specific objective the incidence of each of the study factors: local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain, functional impotence and then compare them between both groups at different times. The anatomopathological study of some of the saphenous vein preparations, one no touch and the other conventional, will also be carried out using optical microscopy and ultrastructural comparisons using transmission electron microscopy. Additionally, patients will be offered computed tomography angiography every year to evaluate graft patency. There are not many relevant randomized clinical trials that compare the morbidity of this technique with the conventional one. In this context, we consider it crucial to evaluate whether there are significant differences in terms of wound morbidity in the mid-postoperative period (1 week), late (1 month) and long-term postoperative period (6 months). We will define each variable previously: it will be considered to have a local infection when the wound shows signs of flow and it has been necessary to start antibiotic treatment, hematoma when there is a tumor or abnormal hardening caused by the accumulation of blood, flictenes when a skin blister appears on the wound that contains watery substances and not pus, secretions when the wound secretes a liquid (serous, bloody, purulent), necrosis when there is a necrotic plaque in the wound larger than 10 x 10 mm, dehiscence of the wound when the suture loses continuity, paresthesia when there is a tingling sensation due to an irritative sensitivity disorder, pain when it is located at the level of the wound and functional impotence when it prevents or limits ambulation. Through multivariate analysis, the relationship with independent factors will be analyzed. Null hypothesis: no touch saphenectomy is inferior to the conventional technique. Alternative hypothesis: no touch saphenectomy is not inferior to the conventional technique. Existing studies have focused their attention on evaluating the patency of the ducts; however, there is a lack of solid information on the morbidity associated with this technique in the lower limb of patients. Currently, the most widely used technique remains the conventional one, which involves a continuous incision in the skin of the leg or thigh. In this technique, a dissection of the subcutaneous tissue surrounding the vein is performed, the collaterals are ligated, and the free venous duct is sectioned. The length of the conduit varies depending on the amount of bypass to be performed. During 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, therefore, it is of great interest for us to evaluate the incidence of the postoperative complications, previously mentioned, and compare these results with those obtained through the conventional technique.

Interventions

PROCEDUREConventional Saphenous vein harvest

The conventional one involves harvesting only the vein, without perivascular tissue or the nerve.

PROCEDURENo touch Saphenous vein harvest

During 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.

Sponsors

Instituto Nacional de Cirugia Cardiaca, Uruguay
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

The patient will not know which group he was assigned to, and the researcher who will evaluate the patients postoperatively will not know either, only the surgeon at the time of performing block randomization prior to surgery.

Intervention model description

Corresponds to a single-center, open, non-inferiority, randomized controlled clinical trial. A probability of complication of saphenectomy by conventional or control technique of 10% was assumed, based on studies from our institution, and according to preliminary studies we expect to find 50% more in the no touch technique, therefore 15%. The non-inferiority limit will be 20%. With these values, assuming a 95% confidence interval and a power (1 - beta) of 80%, and taking into account a probable 20% of lost patients, we can calculate the necessary population sample size, which was in total 52 patients; 26 people in the group with conventional technique and 26 in the no touch.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Demonstrate the non-inferiority of the no touch technique over the conventional technique in terms of wound morbidity.1 week, 1 month, 6 monthsOur 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.

Secondary

MeasureTime frameDescription
Incidence of local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times.1 week, 1 month, 6 monthsFind 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.

Other

MeasureTime frameDescription
Saphenous vein bypass patency1 yearPatients will be offered computed tomography angiography one year after surgery to evaluate graft patency.

Countries

Uruguay

Contacts

Primary ContactJuan A Montero, MD
juani.montero94@gmail.com+59899428604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026