[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554225":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":47,"overallOfficials":61,"centralContacts":66,"locations":71,"responsibleParty":92,"collaborators":27,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":27,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":74,"whyStopped":27,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Instituto Nacional de Cirugia Cardiaca, Uruguay","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14],{"measure":15,"description":16,"timeFrame":12},"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.",[18],{"measure":19,"description":20,"timeFrame":21},"Saphenous vein bypass patency","Patients will be offered computed tomography angiography one year after surgery to evaluate graft patency.","1 year",{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":27,"timePerspective":27,"maskingInfo":28},"RANDOMIZED","PARALLEL","Corresponds to a single-center, open, non-inferiority, randomized controlled clinical trial.\n\nA 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\".","TREATMENT",null,{"masking":29,"maskingDescription":30,"whoMasked":31},"DOUBLE","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.",[32,33],"PARTICIPANT","INVESTIGATOR","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.\n\nGiven 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nAdditionally, patients will be offered computed tomography angiography every year to evaluate graft patency.\n\nThere 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).\n\nWe 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.\n\nThrough multivariate analysis, the relationship with independent factors will be analyzed.\n\nNull hypothesis: \"no touch\" saphenectomy is inferior to the conventional technique.\n\nAlternative hypothesis: \"no touch\" saphenectomy is not inferior to the conventional technique.\n\nExisting 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.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Conventional","EXPERIMENTAL","26 patients will be randomized to this group. The vein harvest technique will be the conventional one.",[41],"Procedure: Conventional Saphenous vein harvest",{"label":43,"type":38,"description":44,"interventionNames":45},"No Touch","26 patients will be randomized to this group. The vein harvest technique will be the \"no touch\".",[46],"Procedure: No touch Saphenous vein harvest",[48,55],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"PROCEDURE","Conventional Saphenous vein harvest","The conventional one involves harvesting only the vein, without perivascular tissue or the nerve.",[37],[54],"Conventional Saphenectomy",{"type":49,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"No touch Saphenous vein harvest","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.",[43],[60],"No touch Saphenectomy",[62],{"name":63,"affiliation":64,"role":65},"Juan A Montero, MD","Instituto Nacional de Cirugía Cardíaca","PRINCIPAL_INVESTIGATOR",[67],{"name":63,"role":68,"phone":69,"phoneExt":27,"email":70},"CONTACT","+59899428604","juani.montero94@gmail.com",[72],{"facility":73,"status":74,"city":75,"state":27,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Instituto Nacional de Cirugia Cardiaca","RECRUITING","Montevideo","11600","Uruguay","UY",{"type":80,"coordinates":81},"Point",[82,83],-56.18816,-34.90328,{"lat":83,"lon":82},[86,88,91],{"name":63,"role":68,"phone":87,"phoneExt":27,"email":70},"+59824810209",{"name":89,"role":90,"phone":27,"phoneExt":27,"email":27},"Victor Dayan, MD, PhD","SUB_INVESTIGATOR",{"name":63,"role":65,"phone":27,"phoneExt":27,"email":27},{"type":93,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100554225","morbidity-of-conventional-and-no-touch-saphenectomy-in-coronary-artery-bypass-grafting-100554225",false,"NCT06496321","Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.","Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting, a Randomized Non-inferiority Clinical Trial","TNT","Inclusion Criteria:\n\n* Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.\n\nExclusion Criteria:\n\n* Emergency surgeries.\n* Poor metabolic control (HbA1c \\> 6.5%).\n* Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.\n* Type II obesity (BMI\\>35).","ALL","18 Years","70 Years",{"count":106,"type":107},52,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.",[113,43,114,115,116],"Saphenectomy","Coronary Artery Disease","Cardiovascular Diseases","Wound Complication",[113,43,114],"2024-07-08",{"date":120,"type":121},"2024-07-11","ACTUAL",{"date":123,"type":121},"2024-03-15",{"date":125,"type":107},"2025-12-31",{"name":5,"class":6},1]