Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496321
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-26
Brief Title:
Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting
Sponsor:
Instituto Nacional de Cirugia Cardiaca Uruguay
Organization:
Instituto Nacional de Cirugia Cardiaca Uruguay
Study Overview
Official Title:
Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting a Randomized Non-inferiority Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
TNT
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
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
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 Oversight
Has Oversight DMC:
None
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?:
None