Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 1:20 AM
Study NCT ID:
NCT07002658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-06
First Post:
2025-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Impact of Surgical Wound Morbidity According to the Type of Saphenous Vein Harvesting Technique (Endoscopic vs. Open) in Patients Undergoing Myocardial Revascularization Surgery
Sponsor:
Hospital San Carlos, Madrid
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EndOSiC
Brief 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). 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.
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.
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)
* 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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: