Impact of saphenous vein harvesting on graft diameter: Supporting the no-touch technique.
Michael R Dashwood, Bruno Botelho Pinheiro, Domingos S R Souza
https://pubmed.ncbi.nlm.nih.gov/36510541Actively Recruiting
Led by Instituto Nacional de Cirugia Cardiaca, Uruguay · Updated on 2024-07-11
52
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Total: 1 location
1
Instituto Nacional de Cirugia Cardiaca
Montevideo, Uruguay, 11600
Actively Recruiting
J
Juan A Montero, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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