SaphenectomyTNTNCT06496321
Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.
A study testing Conventional Saphenous vein harvest and No touch Saphenous vein harvest in people with Saphenectomy and No Touch, run by Instituto Nacional de Cirugia Cardiaca, Uruguay at 1 site in Uruguay.
Trial summary
A clinical research project will be carried out that will consist of a non-inferiority study. The objective is to compare the morbidity of two different surgical techniques for the extraction of the internal saphenous vein, intended to be used as a conduit in coronary bypass. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Saphenectomy, No Touch, Coronary Artery Disease
- What is being tested?
- Conventional Saphenous vein harvest and No touch Saphenous vein harvest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUruguay
- Study dates
- 15 Mar 2024to 31 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.
Who cannot join
- Emergency surgeries.
- Poor metabolic control (HbA1c > 6.5%).
- Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.
- Type II obesity (BMI>35).
Trial locations and contacts
1 site in 1 country.
Uruguay1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cirugia Cardiaca
Montevideo, 11600
Juan A Montero, MD, +59824810209, juani.montero94@gmail.com
Victor Dayan, MD, PhD
About this study
Official title: Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting, a Randomized Non-inferiority Clinical Trial
A clinical research project will be carried out that will consist of a non-inferiority study. The objective is to compare the morbidity of two different surgical techniques for the extraction of the internal saphenous vein, intended to be used as a conduit in coronary bypass.
Read the detailed description
Current clinical trials have shown that the no-touch saphenectomy technique has had a positive impact on the short- and long-term patency of coronary bypass, compared to the conventional extraction technique. It is important to highlight that the conventional technique is the most used in our country (Uruguay, South America), while the "no touch" has fallen into disuse.
Given this disparity in the application of the techniques, it is considered essential to compare both methods in terms of morbidity. For this purpose, a prospective randomized clinical trial will be carried out.
The primary objective is to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence.
The investigators will seek to achieve as a specific objective the incidence of each of the study factors: local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain, functional impotence and then compare them between both groups at different times.
The anatomopathological study of some of the saphenous vein preparations, one "no touch" and the other conventional, will also be carried out using optical microscopy and ultrastructural comparisons using transmission electron microscopy.
Additionally, patients will be offered computed tomography angiography every year to evaluate graft patency.
There are not many relevant randomized clinical trials that compare the morbidity of this technique with the conventional one. In this context, we consider it crucial to evaluate whether there are significant differences in terms of wound morbidity in the mid-postoperative period (1 week), late (1 month) and long-term postoperative period (6 months).
We will define each variable previously: it will be considered to have a local infection when the wound shows signs of flow and it has been necessary to start antibiotic treatment, hematoma when there is a tumor or abnormal hardening caused by the accumulation of blood, flictenes when a skin blister appears on the wound that contains watery substances and not pus, secretions when the wound secretes a liquid (serous, bloody, purulent), necrosis when there is a necrotic plaque in the wound larger than 10 x 10 mm, dehiscence of the wound when the suture loses continuity, paresthesia when there is a tingling sensation due to an irritative sensitivity disorder, pain when it is located at the level of the wound and functional impotence when it prevents or limits ambulation.
Through multivariate analysis, the relationship with independent factors will be analyzed.
Null hypothesis: "no touch" saphenectomy is inferior to the conventional technique.
Alternative hypothesis: "no touch" saphenectomy is not inferior to the conventional technique.
Existing studies have focused their attention on evaluating the patency of the ducts; however, there is a lack of solid information on the morbidity associated with this technique in the lower limb of patients. Currently, the most widely used technique remains the conventional one, which involves a continuous incision in the skin of the leg or thigh. In this technique, a dissection of the subcutaneous tissue surrounding the vein is performed, the collaterals are ligated, and the free venous duct is sectioned. The length of the conduit varies depending on the amount of bypass to be performed. During the extraction of the saphenous vein using the "no touch" technique, it is sectioned with the perivascular adipose tissue and the saphenous nerve of the leg, therefore, it is of great interest for us to evaluate the incidence of the postoperative complications, previously mentioned, and compare these results with those obtained through the conventional technique.
- Conditions
- Saphenectomy, No Touch, Coronary Artery Disease, Cardiovascular Diseases, Wound Complication
- Being tested
- Conventional Saphenous vein harvest, No touch Saphenous vein harvest
- Keywords
- Saphenectomy, No Touch, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Saphenous vein harvestProcedure or surgery
Also called Conventional Saphenectomy
The conventional one involves harvesting only the vein, without perivascular tissue or the nerve.
No touch Saphenous vein harvestProcedure or surgery
Also called No touch Saphenectomy
During the extraction of the saphenous vein using the "no touch" technique, it is sectioned with the perivascular adipose tissue and the saphenous nerve of the leg.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Experimental | 26 patients will be randomized to this group. The vein harvest technique will be the conventional one. Receives: Procedure: Conventional Saphenous vein harvest |
| No Touch | Experimental | 26 patients will be randomized to this group. The vein harvest technique will be the "no touch". Receives: Procedure: No touch Saphenous vein harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity.
Our primary objective will be to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence.
Measured: 1 week, 1 month, 6 months
Secondary outcomes (1)
Incidence of local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times.
Find the incidence of each of the study factors: local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times.
Measured: 1 week, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start15 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SaphenectomyStudies of the same condition, open and under way.
- 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
- Model description
- Corresponds to a single-center, open, non-inferiority, randomized controlled clinical trial. A probability of complication of saphenectomy by conventional or "control" technique of 10% was assumed, based on studies from our institution, and according to preliminary studies we expect to find 50% more in the "no touch" technique, therefore 15%. The non-inferiority limit will be 20%. With these values, assuming a 95% confidence interval and a power (1 - beta) of 80%, and taking into account a probable 20% of lost patients, we can calculate the necessary population sample size, which was in total 52 patients; 26 people in the group with conventional technique and 26 in the "no touch".
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cirugia Cardiaca, Uruguay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan A Montero, MD, Principal investigator, Instituto Nacional de Cirugía Cardíaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496321
- Sponsor's protocol ID
- TNT
- Acronym
- TNT
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dashwood MR, Pinheiro BB, Souza DSR. Impact of saphenous vein harvesting on graft diameter: Supporting the no-touch technique. JTCVS Tech. 2022 Aug 18;16:105-106. doi: 10.1016/j.xjtc.2022.08.011. eCollection 2022 Dec. No abstract available.
PubMed 36510541Deb S, Singh SK, de Souza D, Chu MWA, Whitlock R, Meyer SR, Verma S, Jeppsson A, Al-Saleh A, Brady K, Rao-Melacini P, Belley-Cote EP, Tam DY, Devereaux PJ, Novick RJ, Fremes SE; SUPERIOR SVG Study Investigators. SUPERIOR SVG: no touch saphenous harvesting to improve patency following coronary bypass grafting (a multi-Centre randomized control trial, NCT01047449). J Cardiothorac Surg. 2019 May 2;14(1):85. doi: 10.1186/s13019-019-0887-x.
PubMed 31046806Gaudino M, Antoniades C, Benedetto U, Deb S, Di Franco A, Di Giammarco G, Fremes S, Glineur D, Grau J, He GW, Marinelli D, Ohmes LB, Patrono C, Puskas J, Tranbaugh R, Girardi LN, Taggart DP; ATLANTIC (Arterial Grafting International Consortium) Alliance. Mechanisms, Consequences, and Prevention of Coronary Graft Failure. Circulation. 2017 Oct 31;136(18):1749-1764. doi: 10.1161/CIRCULATIONAHA.117.027597.
PubMed 29084780Inaba Y, Yamazaki M, Ohono M, Yamashita K, Izumida H, Hayashi K, Takahashi T, Kimura N, Ito T, Shimizu H. No-touch saphenous vein graft harvesting technique for coronary artery bypass grafting. Gen Thorac Cardiovasc Surg. 2020 Mar;68(3):248-253. doi: 10.1007/s11748-019-01186-4. Epub 2019 Aug 2.
PubMed 31376117Kopjar T, Dashwood MR. Endoscopic Versus "No-Touch" Saphenous Vein Harvesting for Coronary Artery Bypass Grafting: A Trade-Off Between Wound Healing and Graft Patency. Angiology. 2016 Feb;67(2):121-32. doi: 10.1177/0003319715584126. Epub 2015 May 13.
PubMed 25972395Pettersen O, Haram PM, Winnerkvist A, Karevold A, Wahba A, Stenvik M, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery: Perioperative Data From a Randomized Trial. Ann Thorac Surg. 2017 Oct;104(4):1313-1317. doi: 10.1016/j.athoracsur.2017.03.076. Epub 2017 Jun 23.
PubMed 28648540Ragnarsson S, Janiec M, Modrau IS, Dreifaldt M, Ericsson A, Holmgren A, Hultkvist H, Jeppsson A, Sartipy U, Ternstrom L, Per Vikholm MD, de Souza D, James S, Thelin S. No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2020 Jun;224:17-24. doi: 10.1016/j.ahj.2020.03.009. Epub 2020 Mar 13.
PubMed 32272256Souza DS, Christofferson RH, Bomfim V, Filbey D. "No-touch" technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium. Scand Cardiovasc J. 1999;33(6):323-9. doi: 10.1080/14017439950141362.
PubMed 10622542Samano N, Geijer H, Liden M, Fremes S, Bodin L, Souza D. 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. J Thorac Cardiovasc Surg. 2015 Oct;150(4):880-8. doi: 10.1016/j.jtcvs.2015.07.027. Epub 2015 Jul 15.
PubMed 26282605Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95. doi: 10.1016/s0003-4975(02)03425-2.
PubMed 11996262Souza DS, Arbeus M, Botelho Pinheiro B, Filbey D. The no-touch technique of harvesting the saphenous vein for coronary artery bypass grafting surgery. Multimed Man Cardiothorac Surg. 2009 Jan 1;2009(731):mmcts.2008.003624. doi: 10.1510/mmcts.2008.003624.
PubMed 24413611Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.
PubMed 34510911Tsuneyoshi H, Setozaki S, Katayama H, Wada T, Shimomura S, Takeuchi A, Sugaya A, Komiya T. Early and Midterm Outcomes of "No-Touch" Saphenous Vein Grafts in Japanese Institutions. Braz J Cardiovasc Surg. 2022 Sep 2;37(Spec 1):42-48. doi: 10.21470/1678-9741-2022-0121.
PubMed 36054001Verma S, Lovren F, Pan Y, Yanagawa B, Deb S, Karkhanis R, Quan A, Teoh H, Feder-Elituv R, Moussa F, Souza DS, Fremes SE. Pedicled no-touch saphenous vein graft harvest limits vascular smooth muscle cell activation: the PATENT saphenous vein graft study. Eur J Cardiothorac Surg. 2014 Apr;45(4):717-25. doi: 10.1093/ejcts/ezt560. Epub 2013 Dec 9.
PubMed 24327455Weiss MG, Nielsen PH, James S, Thelin S, Modrau IS. Clinical Outcomes After Surgical Revascularization Using No-Touch Versus Conventional Saphenous Vein Grafts: Mid-Term Follow-Up of Propensity Score Matched Cohorts. Semin Thorac Cardiovasc Surg. 2023 Summer;35(2):228-236. doi: 10.1053/j.semtcvs.2021.12.002. Epub 2021 Dec 5.
PubMed 34879223
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting, a Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06496321
- Acronym / sponsor ID
- TNT / TNT
- Conditions
- Saphenectomy, No Touch, Coronary Artery Disease, Cardiovascular Diseases, Wound Complication
- Keywords
- Saphenectomy, No Touch, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cirugia Cardiaca, UruguayUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 2024 (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.
A clinical research project will be carried out that will consist of a non-inferiority study. The objective is to compare the morbidity of two different surgical techniques for the extraction of the internal saphenous vein, intended to be used as a conduit in coronary bypass.
Detailed description
Current clinical trials have shown that the no-touch saphenectomy technique has had a positive impact on the short- and long-term patency of coronary bypass, compared to the conventional extraction technique. It is important to highlight that the conventional technique is the most used in our country (Uruguay, South America), while the "no touch" has fallen into disuse.
Given this disparity in the application of the techniques, it is considered essential to compare both methods in terms of morbidity. For this purpose, a prospective randomized clinical trial will be carried out.
The primary objective is to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence.
The investigators will seek to achieve as a specific objective the incidence of each of the study factors: local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain, functional impotence and then compare them between both groups at different times.
The anatomopathological study of some of the saphenous vein preparations, one "no touch" and the other conventional, will also be carried out using optical microscopy and ultrastructural comparisons using transmission electron microscopy.
Additionally, patients will be offered computed tomography angiography every year to evaluate graft patency.
There are not many relevant randomized clinical trials that compare the morbidity of this technique with the conventional one. In this context, we consider it crucial to evaluate whether there are significant differences in terms of wound morbidity in the mid-postoperative period (1 week), late (1 month) and long-term postoperative period (6 months).
We will define each variable previously: it will be considered to have a local infection when the wound shows signs of flow and it has been necessary to start antibiotic treatment, hematoma when there is a tumor or abnormal hardening caused by the accumulation of blood, flictenes when a skin blister appears on the wound that contains watery substances and not pus, secretions when the wound secretes a liquid (serous, bloody, purulent), necrosis when there is a necrotic plaque in the wound larger than 10 x 10 mm, dehiscence of the wound when the suture loses continuity, paresthesia when there is a tingling sensation due to an irritative sensitivity disorder, pain when it is located at the level of the wound and functional impotence when it prevents or limits ambulation.
Through multivariate analysis, the relationship with independent factors will be analyzed.
Null hypothesis: "no touch" saphenectomy is inferior to the conventional technique.
Alternative hypothesis: "no touch" saphenectomy is not inferior to the conventional technique.
Existing studies have focused their attention on evaluating the patency of the ducts; however, there is a lack of solid information on the morbidity associated with this technique in the lower limb of patients. Currently, the most widely used technique remains the conventional one, which involves a continuous incision in the skin of the leg or thigh. In this technique, a dissection of the subcutaneous tissue surrounding the vein is performed, the collaterals are ligated, and the free venous duct is sectioned. The length of the conduit varies depending on the amount of bypass to be performed. During the extraction of the saphenous vein using the "no touch" technique, it is sectioned with the perivascular adipose tissue and the saphenous nerve of the leg, therefore, it is of great interest for us to evaluate the incidence of the postoperative complications, previously mentioned, and compare these results with those obtained through the conventional technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Corresponds to a single-center, open, non-inferiority, randomized controlled clinical trial. A probability of complication of saphenectomy by conventional or "control" technique of 10% was assumed, based on studies from our institution, and according to preliminary studies we expect to find 50% more in the "no touch" technique, therefore 15%. The non-inferiority limit will be 20%. With these values, assuming a 95% confidence interval and a power (1 - beta) of 80%, and taking into account a probable 20% of lost patients, we can calculate the necessary population sample size, which was in total 52 patients; 26 people in the group with conventional technique and 26 in the "no touch".
| Arm | Type | Receives |
|---|---|---|
| Conventional | Experimental | Procedure: Conventional Saphenous vein harvest26 patients will be randomized to this group. The vein harvest technique will be the conventional one. |
| No Touch | Experimental | Procedure: No touch Saphenous vein harvest26 patients will be randomized to this group. The vein harvest technique will be the "no touch". |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.
Key exclusion criteria (4 listed)
- Emergency surgeries.
- Poor metabolic control (HbA1c > 6.5%).
- Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.
- Type II obesity (BMI>35).
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 |
|---|---|---|
| Conventional Saphenous vein harvestAlso: Conventional SaphenectomyThe conventional one involves harvesting only the vein, without perivascular tissue or the nerve. | Procedure or surgery | Conventional |
| No touch Saphenous vein harvestAlso: No touch SaphenectomyDuring the extraction of the saphenous vein using the "no touch" technique, it is sectioned with the perivascular adipose tissue and the saphenous nerve of the leg. | Procedure or surgery | No Touch |
Primary outcome
Demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity.
Time frame: 1 week, 1 month, 6 months
Our primary objective will be to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence.
1 secondary outcome
Incidence of local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times.
Time frame: 1 week, 1 month, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 36510541Dashwood MR, Pinheiro BB, Souza DSR. Impact of saphenous vein harvesting on graft diameter: Supporting the no-touch technique. JTCVS Tech. 2022 Aug 18;16:105-106. doi: 10.1016/j.xjtc.2022.08.011. eCollection 2022 Dec. No abstract available.
- Results publication: PubMed 31046806Deb S, Singh SK, de Souza D, Chu MWA, Whitlock R, Meyer SR, Verma S, Jeppsson A, Al-Saleh A, Brady K, Rao-Melacini P, Belley-Cote EP, Tam DY, Devereaux PJ, Novick RJ, Fremes SE; SUPERIOR SVG Study Investigators. SUPERIOR SVG: no touch saphenous harvesting to improve patency following coronary bypass grafting (a multi-Centre randomized control trial, NCT01047449). J Cardiothorac Surg. 2019 May 2;14(1):85. doi: 10.1186/s13019-019-0887-x.
- Results publication: PubMed 29084780Gaudino M, Antoniades C, Benedetto U, Deb S, Di Franco A, Di Giammarco G, Fremes S, Glineur D, Grau J, He GW, Marinelli D, Ohmes LB, Patrono C, Puskas J, Tranbaugh R, Girardi LN, Taggart DP; ATLANTIC (Arterial Grafting International Consortium) Alliance. Mechanisms, Consequences, and Prevention of Coronary Graft Failure. Circulation. 2017 Oct 31;136(18):1749-1764. doi: 10.1161/CIRCULATIONAHA.117.027597.
- Results publication: PubMed 31376117Inaba Y, Yamazaki M, Ohono M, Yamashita K, Izumida H, Hayashi K, Takahashi T, Kimura N, Ito T, Shimizu H. No-touch saphenous vein graft harvesting technique for coronary artery bypass grafting. Gen Thorac Cardiovasc Surg. 2020 Mar;68(3):248-253. doi: 10.1007/s11748-019-01186-4. Epub 2019 Aug 2.
- Results publication: PubMed 25972395Kopjar T, Dashwood MR. Endoscopic Versus "No-Touch" Saphenous Vein Harvesting for Coronary Artery Bypass Grafting: A Trade-Off Between Wound Healing and Graft Patency. Angiology. 2016 Feb;67(2):121-32. doi: 10.1177/0003319715584126. Epub 2015 May 13.
- Results publication: PubMed 28648540Pettersen O, Haram PM, Winnerkvist A, Karevold A, Wahba A, Stenvik M, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery: Perioperative Data From a Randomized Trial. Ann Thorac Surg. 2017 Oct;104(4):1313-1317. doi: 10.1016/j.athoracsur.2017.03.076. Epub 2017 Jun 23.
- Results publication: PubMed 32272256Ragnarsson S, Janiec M, Modrau IS, Dreifaldt M, Ericsson A, Holmgren A, Hultkvist H, Jeppsson A, Sartipy U, Ternstrom L, Per Vikholm MD, de Souza D, James S, Thelin S. No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2020 Jun;224:17-24. doi: 10.1016/j.ahj.2020.03.009. Epub 2020 Mar 13.
- Results publication: PubMed 10622542Souza DS, Christofferson RH, Bomfim V, Filbey D. "No-touch" technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium. Scand Cardiovasc J. 1999;33(6):323-9. doi: 10.1080/14017439950141362.
- Results publication: PubMed 26282605Samano N, Geijer H, Liden M, Fremes S, Bodin L, Souza D. 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. J Thorac Cardiovasc Surg. 2015 Oct;150(4):880-8. doi: 10.1016/j.jtcvs.2015.07.027. Epub 2015 Jul 15.
- Results publication: PubMed 11996262Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95. doi: 10.1016/s0003-4975(02)03425-2.
- Results publication: PubMed 24413611Souza DS, Arbeus M, Botelho Pinheiro B, Filbey D. The no-touch technique of harvesting the saphenous vein for coronary artery bypass grafting surgery. Multimed Man Cardiothorac Surg. 2009 Jan 1;2009(731):mmcts.2008.003624. doi: 10.1510/mmcts.2008.003624.
- Results publication: PubMed 34510911Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.
- Individual participant dataSharing planned: No
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Limb Edema, Surgical Site Infections
Not yet recruiting
Clinical Impact of Surgical Wound Morbidity According to the Type of Saphenous Vein Harvesting Technique (Endoscopic vs. Open) in Patients Undergoing Myocardial Revascularization Surgery
CABG-patients, Saphenectomy
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.
Juan A Montero, MD principal investigator
Instituto Nacional de Cirugía Cardíaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Saphenous vein harvest and No touch Saphenous vein harvest in people with Saphenectomy and No Touch, run by Instituto Nacional de Cirugia Cardiaca, Uruguay at 1 site in Uruguay.
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 4 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 11 Jul 2024. 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 Uruguay. 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?
Contact Juan A Montero, MD (+59899428604, juani.montero94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity. (time frame: 1 week, 1 month, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496321, which also lists 15 linked publications.
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 11 Jul 2024.