The optimum segment of No-Touch veins for bypassing is still undefined. The purpose of this study is to assess the incidence of leg wound complication after No-Touch harvesting of proximal segment of saphenous veins compared to distal segment of veins in the leg. Graft occlusion rates between the two segments of veins for bypassing will also be compared during follow-up.
This is a prospective, single-center, open-label, randomized within-subject-controlled trial. We aim to randomize 100 patients undergoing isolated coronary artery bypass graft (CABG). We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. In each patient, one saphenous vein graft (SVG) will be randomized to be the proximal segment, while another will be the distal segment as control. Healing of leg wounds will be assessed on day 6 post-operatively. Follow-up will be performed via face-to-face interview until at least 1 year after the operation by CT angiography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
two longitudinal incisions are made on the thigh and shank from unilateral lower limb (for harvesting of proximal segment of saphenous vein, incision is started from about 3 or 4cms inferolateral to the pubic tubercle and then extended downward). As previous reported. the adventitia and perivascular tissue are carefully kept intact to avoid damage. Then a margin of about 5 mm from both sides of the vein is created to include the fat pedicle using electrocautery, and all visible side branches are ligated with 4-0 silk or by metal clipping (branches are divided at the pedicle margin rather than the vein trunk). The saphenous vein is then separated from its bed using scissors and electrocautery, together with surrounding tissue.
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China
RECRUITINGMajor leg wound complication at 6 days postoperatively
a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure
Time frame: 6 days postoperatively
Major leg wound complication during 3-month follow-up
a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure
Time frame: 3 month
Graft vessel occlusion at 3 month and 1 year
Graft occlusion is detected by multislice computed tomography angiography (MSCTA). Graft assessment is conducted according to the FitzGibbon criteria. Each graft is graded as A (excellent), B (fair), or O (occluded). Contrast filling of the grafts, anastomoses, and coronary arteries beyond the graft are considered in each assessment. Grade A indicates that the graft is patent with ≤50% stenosis. Grade B indicates that graft stenosis is \>50% but not occluded. When a conduit does not fill with contrast at all, it is considered Grade O and included with string sign found in any segment (including proximal anastomotic site, distal anastomotic site, and main trunk). Both of these latter findings are considered together and referred to as occlusion in the analysis.
Time frame: 3 months and 1 year
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