[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617428":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":93,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":23,"enrollmentInfo":110,"targetDuration":23,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Standard (non-antiseptic coated) suture will be used.","You will undergo your primary surgery per standard practice at the discretion of your surgeon. Standard Sutures will be used during your operation.",[12],"Device: Standard (non-antiseptic coated) suture will be used.",{"label":14,"type":6,"description":15,"interventionNames":16},"Triclosan\u002Fantiseptic -coated suture","You will undergo your primary surgery per standard practice at the discretion of your surgeon. Triclosan\u002Fantiseptic -coated suture will be used. Ethicon PDSTM Plus Antibacterial Suture will be used at the layer of the pancreatojejunostomy and for the duration of the case.",[17],"Device: Triclosan\u002Fantiseptic -coated suture",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","This is an operation to treat tumors and other conditions in the pancreas, small intestine, and bile ducts. It involves removing the head of the pancreas, the first part of the small intestine, the gallbladder, and the bile duct. Part of the procedure involves sutures. A suture(s) is a stitch or row of stitches holding together the edges of a wound or surgical incision",[9],null,{"type":20,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"Triclosan\u002Fantiseptic -coated suture will be used. Ethicon PDSTM Plus Antibacterial Suture will be used at the layer of the pancreatojejunostomy and for the duration of the case.",[14],[28],{"name":29,"affiliation":5,"role":30},"Toms Augustin, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":23,"email":36},"Christine Moegling, BS","CONTACT","216 399-4706","Drabekc@ccf.org",[38,57,75],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Cleveland Clinic Akron","RECRUITING","Akron","Ohio","44307","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.51901,41.08144,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":23,"email":56},"Tom Callihan","330 344-6993","CALLIHT3@ccf.org",{"facility":58,"status":40,"city":59,"state":42,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Cleveland Clinic","Cleveland","44195",{"type":47,"coordinates":62},[63,64],-81.69541,41.4995,{"lat":64,"lon":63},[67,71],{"name":68,"role":34,"phone":69,"phoneExt":23,"email":70},"Divya Deverakonda, MD","216 379-3486","deverad3@ccf.org",{"name":72,"role":34,"phone":73,"phoneExt":23,"email":74},"Noah Tocci, MD","216 346-1447","toccin@ccf.org",{"facility":76,"status":40,"city":77,"state":42,"zip":78,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Cleveland Clinic Fairview Hospital","Fairview","44111",{"type":47,"coordinates":80},[81,82],-81.23289,40.05701,{"lat":82,"lon":81},[85,89],{"name":86,"role":34,"phone":87,"phoneExt":23,"email":88},"Erica Linna, RN BSN","216 633-5073","LINNAE@ccf.org",{"name":90,"role":34,"phone":91,"phoneExt":23,"email":92},"Shweta Josh","216 312-6601","JOSHS@ccf.org",{"type":30,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Toms Augustin","Medical Director (Main Campus) - Safety, Quality and Patient Experience",[97],{"name":98,"class":99},"Ethicon, Inc.","INDUSTRY","100617428","antiseptic-coated-sutures-and-pancreatic-fistula-risk-after-pancreatoduodenectomy-100617428",false,"NCT07318493","Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy","Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial","Triclosan","Inclusion Criteria:\n\n* Subjects must be undergoing a scheduled pancreatoduodenectomy.\n* Age ≥18 years.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years old\n* Patients who are pregnant\n* Patients with history of previous pancreatic surgery\n* Patients who are unable to provide informed consent","ALL","18 Years",{"count":111,"type":112},436,"ESTIMATED","INTERVENTIONAL",[115],"NA","The purpose of this study is to determine if the use of antiseptic-coated sutures is better than the use of the standard sutures in preventing postoperative fistulas within 90 days after pancreatoduodenectomy.",[118,119],"Pancreatoduodenectomy","Whipple Procedure",[121,122,123],"pancreatoduodenectomy","whipple procedure","sutures","2026-01-19",{"date":126,"type":127},"2026-01-21","ACTUAL",{"date":129,"type":127},"2026-01-13",{"date":131,"type":112},"2031-02",{"name":5,"class":6},3]