CABG-patientsEndOSiCNCT07002658
Clinical Impact of Surgical Wound Morbidity According to the Type of Saphenous Vein Harvesting Technique (Endoscopic vs. Open) in Patients Undergoing Myocardial Revascularization Surgery
A study testing Harvesting of the saphenous vein graft in people with CABG-patients and Saphenectomy, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
The goal of this clinical trial is to compare two different techniques: endoscopic saphenous vein harvesting versus conventional open harvesting in patients undergoing coronary artery bypass grafting, either alone or in combination with another cardiac surgical procedure (valve surgery or arrhythmia surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG-patients, Saphenectomy, Endoscopic Surgery
- What is being tested?
- Harvesting of the saphenous vein graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2025to 1 Aug 2026
- Phase
- Interventional
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 undergoing coronary artery bypass grafting (CABG), alone or in combination with other surgery (valve or arrhythmia surgery), with or without cardiopulmonary bypass (CPB), in which preoperative evaluation includes the plan to use a short saphenous vein segment (alone or in addition to arterial conduits).
- Availability of a surgeon or cardiac surgery resident trained in endoscopic harvesting in the operating room.
- Patients undergoing myocardial revascularization surgeries with or without extracorporeal circulation.
- Patients undergoing concomitant cardiac valve replacement surgery, atrial fibrillation surgery, and others, in addition to CABG
Who cannot join
- Emergent surgery or procedures performed during cardiorespiratory arrest
- Myocardial revascularization with arterial grafts only
- Presence of varicose veins
- History of infrainguinal vascular surgery
- Presence of ulcers and/or active infection in the lower limbs
- Previous stroke with neurological sequelae in the legs
Show all 10Show fewer
- History of deep vein thrombosis in the legs
- Pregnancy
- Age under 18 years
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Clínico San Carlos
Madrid, Madrid, 28040
Maria B Solis, MD, +34613888798, mabesolis95@gmail.com
mabesolis95@gmail.com
About this study
Official title: Endoscopic Saphenous Vein Harvesting Versus Conventional Open Harvesting in Patients Undergoing Coronary Artery Bypass Grafting, Either Alone or in Combination With Another Cardiac Surgical Procedure, in Terms of the Clinical Impact of Surgical Wound Morbidity
The goal of this clinical trial is to compare two different techniques: endoscopic saphenous vein harvesting versus conventional open harvesting in patients undergoing coronary artery bypass grafting, either alone or in combination with another cardiac surgical procedure (valve surgery or arrhythmia surgery). The main questions the trial aims to answer are:
Does the endoscopic technique reduce surgical wound morbidity in terms of shorter hospital stays? Does endoscopic saphenous harvesting reduce the use of antibiotics for saphenectomy wound infections? Does the endoscopic technique reduce need for wound dressings due to necrosis and/or wound infection, and reduce need for analgesic treatment for wound pain? This prospective, randomized study will be conducted in the Cardiovascular Surgery Service at Hospital Clínico San Carlos.
Participants will be randomly assigned to a different saphenectomy technique. All patients will be assessed for saphenectomy wound complications upon discharge, and by phone call at 7 days, 1 month, and 3 months following the intervention.
Read the detailed description
- Pain in the leg incisions will be assessed using a standarized pain scale.
- Antibiotic and analgesic requirements for infection or pain in the saphenous vein surgical wound will be documeted.
- The need for outpatient treatment or hospitalization due to surgical wounds will be evaluated.
- A surgical wound cosmetic satisfaction survey will be administered to participants.
- Images of the saphenectomy surgical wound will be collected at 1 month postoperatively.
- Major cardiovascular events will be monitored during follow-up visits or hospital admissions and recorded in the RECC database (local service database)
- Conditions
- CABG-patients, Saphenectomy, Endoscopic Surgery, Wound Complications, Antibiotic Use, Cardiac Surgery
- Being tested
- Harvesting of the saphenous vein graft
- Keywords
- endoscopic vein harvesting, CABG surgery, open vein harvesting, wound morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting of the saphenous vein graftProcedure or surgery
Most existing studies on endoscopic saphenectomy have been conducted in CABG with cardiopulmonary bypass (CBP), whereas most CABG surgeries at the study center are performed without CBP.
The following outcomes will be identified:
- Days of admission or need for hospitalization
- Use of antibiotic therapy for saphenectomy wound infections
- Need for wound dressings due to necrosis and/or wound infection
- Need for analgesic treatment for wound pain
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic saphenectomy | Experimental | Endoscopic vein harvesting in CABG surgery requiring a vein graft with or without extracorporeal circulation Receives: Procedure: Harvesting of the saphenous vein graft |
| Conventional and open technique for saphenous vein harvesting | Active comparator | Using the conventional open technique for harvesting the saphenous vein in any type of surgery with or without extracorporeal circulation Receives: Procedure: Harvesting of the saphenous vein graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound morbidity
Days of hospital stay, use of antibiotics for saphenectomy wound infections, need for wound dressings due to necrosis and/or wound infection, and need for analgesic treatment for wound pain.
- Length of Hospital Stay. Unit of Measure: Days
- Use of Antibiotics for Saphenectomy Wound Infections Measure: Number of participants requiring oral or parenteral antibiotics due to wound infection. Unit of Measure: Participants
- Need for Wound Dressings Due to Necrosis and/or Infection Measure: Number of participants requiring wound dressings due to necrosis and/or wound infection. Unit of Measure: Participants
- Use of Analgesics for Wound Pain Measure: Number of participants requiring analgesic treatment for saphenectomy wound pain
Measured: From enrollment to the three-month follow-up visit
Secondary outcomes (1)
Freedom from combined cardiac events
Freedom from death, myocardial infarction, and recurrent angina
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CABG-patientsStudies 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
- One group will receive the open technique for saphenous vein harvesting and the other group will receive the endoscopic technique.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Belén Solís Chávez, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002658
- Sponsor's protocol ID
- 25/148-E
- Acronym
- EndOSiC
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the IPD data will be share at the end of the study
Publications
Zenati MA, Bhatt DL, Bakaeen FG, Stock EM, Biswas K, Gaziano JM, Kelly RF, Tseng EE, Bitondo J, Quin JA, Almassi GH, Haime M, Hattler B, DeMatt E, Scrymgeour A, Huang GD; REGROUP Trial Investigators. Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass. N Engl J Med. 2019 Jan 10;380(2):132-141. doi: 10.1056/NEJMoa1812390. Epub 2018 Nov 11.
PubMed 30417737Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available.
PubMed 30165632Sampath HK, Lee TJH, Cher CE, Liang S, Cheong OO, Kofidis T, Vitaly S, Sazzad F. A Comprehensive Clinical Outcome Analysis of Endoscopic Vessel Harvesting for Coronary Artery Bypass Surgery. J Clin Med. 2024 Jun 11;13(12):3405. doi: 10.3390/jcm13123405.
PubMed 38929933Li G, Zhang Y, Wu Z, Liu Z, Zheng J. Mid-term and long-term outcomes of endoscopic versus open vein harvesting for coronary artery bypass: A systematic review and meta-analysis. Int J Surg. 2019 Dec;72:167-173. doi: 10.1016/j.ijsu.2019.11.003. Epub 2019 Nov 9.
PubMed 31707009Kopjar T, Dashwood MR. Towards Endoscopic No-Touch Saphenous Vein Graft Harvesting in Coronary Bypass Surgery. Braz J Cardiovasc Surg. 2022 Sep 2;37(Spec 1):57-65. doi: 10.21470/1678-9741-2022-0144.
PubMed 36054003Kodia K, Patel S, Weber MP, Luc JGY, Choi JH, Maynes EJ, Rizvi SA, Horan DP, Massey HT, Entwistle JW, Morris RJ, Tchantchaleishvili V. Graft patency after open versus endoscopic saphenous vein harvest in coronary artery bypass grafting surgery: a systematic review and meta-analysis. Ann Cardiothorac Surg. 2018 Sep;7(5):586-597. doi: 10.21037/acs.2018.07.05.
PubMed 30505742Fudulu D, Angelini GD. Saphenous vein graft longevity: open or endoscopic, with VEST or without? Eur J Cardiothorac Surg. 2022 Jun 15;62(1):ezac144. doi: 10.1093/ejcts/ezac144. No abstract available.
PubMed 35323908Allen KB, Heimansohn DA, Robison RJ, Schier JJ, Griffith GL, Fitzgerald EB. Influence of endoscopic versus traditional saphenectomy on event-free survival: five-year follow-up of a prospective randomized trial. Heart Surg Forum. 2003;6(6):E143-5.
PubMed 14722001