Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.

NCT06496321 | Recruiting DMC

• 1 other identifier: TNT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Saphenectomy; No Touch; Coronary Artery Disease; Cardiovascular Diseases; Wound Complication

Keywords

Saphenectomy; No Touch; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 week, 1 month, 6 months

Other Outcomes (1)

• Saphenous vein bypass patency

  1 year

Study Arms (2)

Conventional

EXPERIMENTAL

26 patients will be randomized to this group. The vein harvest technique will be the conventional one.

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".

Procedure: No touch Saphenous vein harvest

Interventions

Conventional Saphenous vein harvest PROCEDURE

The conventional one involves harvesting only the vein, without perivascular tissue or the nerve.

Also known as: Conventional Saphenectomy

Conventional

No touch Saphenous vein harvest PROCEDURE

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.

Also known as: No touch Saphenectomy

No Touch

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.

You may not qualify if:

• Emergency surgeries.
• Poor metabolic control (HbA1c \> 6.5%).
• Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.
• Type II obesity (BMI\>35).

Sponsors & Collaborators

• Instituto Nacional de Cirugia Cardiaca, Uruguay: lead

Study Sites (1)

Instituto Nacional de Cirugia Cardiaca

Montevideo, 11600, Uruguay

RECRUITING

Related Publications (15)

• 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.

  PMID: 36510541 RESULT

• Deb 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.

  PMID: 31046806 RESULT

• Gaudino 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.

  PMID: 29084780 RESULT

• Inaba 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.

  PMID: 31376117 RESULT

• Kopjar 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.

  PMID: 25972395 RESULT

• Pettersen 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.

  PMID: 28648540 RESULT

• Ragnarsson 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.

  PMID: 32272256 RESULT

• Souza 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.

  PMID: 10622542 RESULT

• Samano 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.

  PMID: 26282605 RESULT

• Souza 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.

  PMID: 11996262 RESULT

• Souza 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.

  PMID: 24413611 RESULT

• Tian 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.

  PMID: 34510911 RESULT

• Tsuneyoshi 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.

  PMID: 36054001 RESULT

• Verma 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.

  PMID: 24327455 RESULT

• Weiss 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.

  PMID: 34879223 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Juan A Montero, MD

  Instituto Nacional de Cirugía Cardíaca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan A Montero, MD

CONTACT

+59899428604; juani.montero94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient will not know which group he was assigned to, and the researcher who will evaluate the patients postoperatively will not know either, only the surgeon at the time of performing block randomization prior to surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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".

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 11, 2024
• Study Start: March 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1)