Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

Leg Wound Complication After No-Touch Harvestingof Veins Clinical Trial

Official title:

Major Leg Wound Complications Between the Proximal and Distal Segments of Saphenous Veins Harvested by No-Touch Technique in Coronary Artery Bypass Graft Surgery: a Single-center Randomized Within-subject Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04284956
• Other study ID #: 2019-F06
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2020
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 or older who undergo primary isolated open-chest CABG with two vein grafts, one to the left coronary territory and the other to the right, with or without cardiopulmonary bypass

Exclusion Criteria:

• Concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)

• Redo CABG

• Emergent CABG (cardiogenic shock, inotropic pressure support, IABP)

• Severe vein varicosity as assessed after vein harvesting and before randomization

• Use of vascular stapler for anastomosis

• Endarterectomy of coronary artery during surgery

• Left ventricular repair due to ventricular aneurysm

• Concomitant life-threatening disease likely to limit life expectancy to less than two years

• Severe renal insufficiency (i.e. creatinine >200 µmol/L)

• Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer

• Participant of other ongoing clinical trials

Related Conditions & MeSH terms

• Leg Wound Complication After No-Touch Harvestingof Veins
• Wounds and Injuries

Intervention

Procedure:
• Proximal and distal segment of saphenous vein harvested by No-Touch technique
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.

Locations

Country	Name	City	State
China	Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major adverse cardiac or cerebrovascular events (MACCE)	including cardiovascular death, non-fatal myocardial infarction (MI), stroke and target vessel revascularization	3 months and 1 year
Other	Individual MACCE	including cardiovascular death, non-fatal myocardial infarction, stroke and target vessel revascularization	3 months and 1 year
Other	Recurrence of angina	Events that fulfill the following definition are to be coded as Angina: i. ischemic chest pain or equivalent (e.g. arm, neck or jaw pain or discomfort thought to be related to cardiac ischemia); and ii. no evidence of MI; and iii. no clear alternative (non-cardiac) explanation (e.g. anemia, arrhythmia)	3 months and 1 year
Primary	Major 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	6 days postoperatively
Secondary	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	3 month
Secondary	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.	3 months and 1 year