Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06496321

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

Led by Instituto Nacional de Cirugia Cardiaca, Uruguay · Updated on 2024-07-11

52

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a randomized clinical trial to compare the morbidity of two surgical techniques used to remove the internal saphenous vein for coronary artery bypass grafting. The study aims to determine whether the "no touch" technique is not inferior to the conventional method regarding wound complications such as infection, hematoma, blisters, secretions, necrosis, wound opening, numbness, pain, and functional limitations. This research is important because the conventional technique is more commonly used locally, while the no touch method has shown potential benefits but is less frequently applied. Participants will be randomly assigned to undergo either the conventional saphenous vein harvest, which removes only the vein, or the no touch technique, where the vein is taken along with surrounding tissue and the saphenous nerve. A total of 52 patients will be divided evenly between these two groups to compare outcomes. The study includes detailed tissue analysis using microscopy and annual computed tomography angiography to assess graft openness. During the study, patients will be monitored for wound-related complications at 1 week, 1 month, and 6 months after surgery. Researchers will assess local infections, hematomas, blisters, secretions, necrosis, wound reopening, numbness, pain, and walking difficulties. Data will be analyzed to identify factors influencing these outcomes. The study aims to provide clear comparisons of morbidity between the two vein harvesting methods over short- and long-term periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing coordinated coronary revascularization surgery requiring the internal saphenous vein as a conduit
  • Age between 18 and 70 years
  • Both male and female patients
Not Eligible

You will not qualify if you...

  • Emergency surgeries
  • Poor metabolic control with HbA1c greater than 6.5%
  • Chronic venous insufficiency or chronic obstructive arterial disease in the lower limbs
  • Type II obesity with BMI greater than 35

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and hospital stay duration

Participants undergo coronary revascularization surgery with either conventional or no-touch saphenous vein harvest techniques and receive immediate post-operative care.

1 surgical procedure and immediate hospital care

Post-operative Follow-up

Duration - 6 months

Participants are monitored for wound morbidity, including local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain, and functional impairment at 1 week, 1 month, and 6 months after surgery.

3 follow-up visits at 1 week, 1 month, and 6 months post-surgery

Long-term Monitoring

Duration - Annual assessments after 6 months

Participants are offered annual computed tomography angiography to evaluate graft patency over the long term.

Annual visits for computed tomography angiography

Trial Site Locations

Total: 1 location

1

Instituto Nacional de Cirugia Cardiaca

Montevideo, Uruguay, 11600

Actively Recruiting

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Research Team

J

Juan A Montero, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

SUPERIOR SVG: no touch saphenous harvesting to improve patency following coronary bypass grafting (a multi-Centre randomized control trial, NCT01047449).

Saswata Deb, Steve K Singh, Domingos de Souza...

https://pubmed.ncbi.nlm.nih.gov/31046806

Endoscopic Versus "No-Touch" Saphenous Vein Harvesting for Coronary Artery Bypass Grafting: A Trade-Off Between Wound Healing and Graft Patency.

Tomislav Kopjar, Michael R Dashwood

https://pubmed.ncbi.nlm.nih.gov/25972395

No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

Sigurdur Ragnarsson, Mikael Janiec, Ivy Susanne Modrau...

https://pubmed.ncbi.nlm.nih.gov/32272256

"No-touch" technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium.

D S Souza, R H Christofferson, V Bomfim...

https://pubmed.ncbi.nlm.nih.gov/10622542

The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: A randomized trial.

Ninos Samano, Håkan Geijer, Mats Liden...

https://pubmed.ncbi.nlm.nih.gov/26282605

Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques.

Domingos S R Souza, Michael R Dashwood, Janice C S Tsui...

https://pubmed.ncbi.nlm.nih.gov/11996262