Leg Wound Complication After No-Touch Harvestingof VeinsNCT04284956
Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts
A study testing Proximal and distal segment of saphenous vein harvested by No-Touch technique in people with Leg Wound Complication After No-Touch Harvestingof Veins, run by China National Center for Cardiovascular Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Wound Complication After No-Touch Harvestingof Veins
- What is being tested?
- Proximal and distal segment of saphenous vein harvested by No-Touch technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Meice Tian, M.D., +8613718863077, tianmeice@fuwaihospital.org
Shengshou Hu, M.D.
About this study
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
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.
Read the detailed 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.
- Being tested
- Proximal and distal segment of saphenous vein harvested by No-Touch technique
- Keywords
- leg wound complication, No-Touch saphenous vein harvesting technique, coronary artery bypass graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal and distal segment of saphenous vein harvested by No-Touch techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Proximal group | Experimental | Proximal segment of saphenous veins are harvested from the thigh by No-Touch technique and randomized to bypass the left or right territory of coronary system Receives: Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique |
| Distal group | Active comparator | Distal segment of saphenous veins are harvested from the shank of the ipsilateral leg by No-Touch technique and used to bypass the right or left territory of coronary system (depending on the randomizing result of the proximal segments) Receives: Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 days postoperatively
Secondary outcomes (2)
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
Measured: 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.
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Wound Complication After No-Touch Harvestingof VeinsStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284956
- Sponsor's protocol ID
- 2019-F06
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04284956
- Acronym / sponsor ID
- 2019-F06
- Keywords
- leg wound complication, No-Touch saphenous vein harvesting technique, coronary artery bypass graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal group | Experimental | Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch techniqueProximal segment of saphenous veins are harvested from the thigh by No-Touch technique and randomized to bypass the left or right territory of coronary system |
| Distal group | Active comparator | Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch techniqueDistal segment of saphenous veins are harvested from the shank of the ipsilateral leg by No-Touch technique and used to bypass the right or left territory of coronary system (depending on the randomizing result of the proximal segments) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal and distal segment of saphenous vein harvested by No-Touch techniquetwo 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. | Procedure or surgery | Distal group, Proximal group |
Primary outcome
Major leg wound complication at 6 days postoperatively
Time frame: 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
2 secondary outcomes
Major leg wound complication during 3-month follow-up
Time frame: 3 month
Graft vessel occlusion at 3 month and 1 year
Time frame: 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal and distal segment of saphenous vein harvested by No-Touch technique in people with Leg Wound Complication After No-Touch Harvestingof Veins, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major leg wound complication at 6 days postoperatively (time frame: 6 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.