[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558132":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":97,"collaborators":99,"id":102,"slug":10,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":10,"enrollmentInfo":111,"targetDuration":10,"studyType":114,"phases":10,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":121,"whyStopped":10,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Aesculap AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Optilene® Silver Mesh Elastic",null,"Prophylactic mesh in high-risk patients",[13],"Device: Prophylactic 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Dr.",{"name":48,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":51,"status":10,"city":37,"state":10,"zip":10,"country":39,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Hospital Municipal Badalona",{"type":41,"coordinates":53},[43,44],{"lat":44,"lon":43},[56,58],{"name":57,"role":28,"phone":10,"phoneExt":10,"email":10},"Jorge Marroquin, Dr.",{"name":57,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":60,"status":10,"city":61,"state":10,"zip":62,"country":39,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Hospital Comarcal Sant Jaume de Calella","Calella","08370",{"type":41,"coordinates":64},[65,66],2.65423,41.61381,{"lat":66,"lon":65},[69,71],{"name":70,"role":28,"phone":10,"phoneExt":10,"email":10},"Paqui Vasco, Dr.",{"name":70,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":73,"status":10,"city":74,"state":10,"zip":75,"country":39,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Hospital de Mataró","Mataró","08304",{"type":41,"coordinates":77},[78,79],2.4445,41.54211,{"lat":79,"lon":78},[82,84],{"name":83,"role":28,"phone":10,"phoneExt":10,"email":10},"Berhanu Chimdi, Dr.",{"name":83,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":86,"status":10,"city":87,"state":10,"zip":88,"country":39,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hospital Fundació Esperit Sant","Santa Coloma de Gramenet","08923",{"type":41,"coordinates":90},[91,92],2.2081,41.45152,{"lat":92,"lon":91},[95,96],{"name":22,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":98,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[100],{"name":101,"class":6},"B.Braun Surgical SA","100558132",false,"NCT06547138","Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)","Prospective Descriptive Multicentre Pilot Study On The Effectiveness and Safety Of Optilene® Silver Mesh Elastic In Prevention Of Surgical Site Infection (SSI) And Incisional Hernia (IH)","SSIHLVER","Inclusion Criteria:\n\n* Adult patients (18 years or older)\n* Surgical procedure requiring urgent, primary median laparotomy, which are classified as \"Class III\u002FContaminated\" or \"Class IV\u002FDirty-Infected\" regarding the CDC classification.\n\nThese include but are not limited to:\n\n* Vascular surgery\n* Colon and rectum\n* Hepatobiliary\n* Gastrointestinal\n* Gynecology\n* Urology\n* Abdominal Aortic Aneurysm (AAA) repair\n* Right hemicolectomy\n* Left hemicolectomy\n* Sigmoidectomy\n* Anterior resection\n* Abdominoperineal amputation\n* Exploratory laparotomy\n* Cholecystectomy\n* Cholecystectomy and choledocotomy\n\n  * Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast feeding\n* Patients \\\u003C 18 years old or patients who are still in the growth phase\n* Contaminated and infected areas\n* Hypersensitivity to silver\n* Direct contact with the viscera\n* Previous allergic reactions to components of the device\n* Patient with previous laparotomy\n* Transverse laparotomy\n* Patients with previous hernia repair\n* Simultaneous participation in another investigational clinical trial (drug or medical studies)\n* Patients with active oncologic treatment (chemo and radiotherapy)\n* Underlying autoimmune disease\n* Recent cardiovascular complication\n* Gynecology surgery\n* Urology surgery\n* Vascular surgery","ALL","18 Years",{"count":112,"type":113},110,"ESTIMATED","OBSERVATIONAL","The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.",[117,118],"Abdominal Aortic Aneurysm","Morbid Obesity",[120],"urgent, primary median laparotomy","NOT_YET_RECRUITING","2026-06-01",{"date":124,"type":125},"2026-06-02","ACTUAL",{"date":127,"type":113},"2026-09",{"date":129,"type":113},"2028-09",{"name":5,"class":6},5]