[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519428":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":71,"collaborators":50,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":50,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":50,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":104,"whyStopped":50,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of Southern California","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Triclosan-coated barbed suture group","ACTIVE_COMPARATOR","The active arm of the study will including patients randomized to abdominal fascial closure with using triclosan-coated barbed (STRATAFIX™ Symmetric PDS™, Johnson \\& Johnson) suture after emergency exploratory laparotomy.",[13],"Device: triclosan-coated barbed suture",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-barbed suture group","PLACEBO_COMPARATOR","The control arm of the study will including patients randomized to abdominal fascial closure with using non-barbed triclosan-coated suture(PDS™ Plus, Johnson \\& Johnson) or non-coated polydioxanone (PDS™ II,Johnson \\& Johnson) suture after emergency exploratory laparotomy.",[19,20],"Device: triclosan-coated non-barbed suture","Device: Non-coated non-barbed suture",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","triclosan-coated barbed suture","STRATAFIX™ Symmetric PDS™ (Johnson \\& Johnson) triclosan-coated polydioxanone barbed suture caliber 0 or 1 will be the standardized suture used for abdominal fascial closure in patients randomized to the treatment group. STRATAFIX™ Symmetric PDS™ is an FDA approved sterile, synthetic, absorbable, barbed triclosan-coated polydioxanone suture. Its indications for use include soft tissue approximation where absorbable suture is appropriate.",[9],[28],"STRATAFIX™ Symmetric PDS™",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"triclosan-coated non-barbed suture","PDS™ Plus (Johnson \\& Johnson) non-barbed triclosan-coated polydioxanone suture in either 0 or 1 caliber will be used for abdominal fascial closure in patients randomized to the control group. PDS™ Plus is an FDA approved sterile, synthetic, absorbable, triclosan-coated surgical monofilament suture prepared from the polyester, poly(p-dioxanone). Its indications for use include soft tissue approximation where absorbable suture is appropriate.",[15],[34],"PDS™ Plus",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Non-coated non-barbed suture","PDS™ II (Johnson \\& Johnson) non-barbed non-coated polydioxanone suture in either 0 or 1 caliber will be used for abdominal fascial closure in patients randomized to the control group. PDS™ II is a FDA approved sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, polyester, poly(p-dioxanone) indicated for use in soft tissue approximation where absorbable suture is appropriate.",[15],[40],"PDS™ II",[42],{"name":43,"affiliation":44,"role":45},"Matthew Martin, MD","Los Angeles General Medical Center","PRINCIPAL_INVESTIGATOR",[47,52],{"name":43,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","323-409-8597",null,"matthew.martin@med.usc.edu",{"name":53,"role":48,"phone":49,"phoneExt":50,"email":54},"Patrick K McGillen, MD","patrick.mcgillen@med.usc.edu",[56],{"facility":44,"status":50,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Los Angeles","California","90033","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-118.24368,34.05223,{"lat":66,"lon":65},[69,70],{"name":43,"role":48,"phone":50,"phoneExt":50,"email":51},{"name":53,"role":48,"phone":50,"phoneExt":50,"email":54},{"type":45,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Matthew Martin","Professor of Surgery, Director of Acute Care Surgery Research","100519428","barbed-suture-vs-non-barbed-closure-for-emergency-exploratory-laparotomy-rct-100519428",false,"NCT06043414","Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT","Incisional Surgical Site Infection and Fascial Dehiscence After Abdominal Fascial Closure With Triclosan-Coated Barbed Suture vs Polydioxanone Suture After Emergency Exploratory Laparotomy: A Randomized Control Trial","Inclusion Criteria:\n\n* All adult individuals aged 18 years or older who undergo emergent laparotomy via a midline approach for trauma or non-trauma emergency general surgery who undergo complete fascial closure at the time of the index laparotomy operation.\n* Individuals with CDC Class I, II, III and IV type surgical wounds\n\nExclusion Criteria:\n\n* Individuals under 18 years of age\n* Individuals with known immune deficiencies\n* Individuals taking chronic immunosuppressive medications\n* Individuals presenting with nosocomial infections\n* Individuals presenting with pre-existing abdominal wall hernia\n* Individuals requiring multiple operations for sequential fascial closure\n* Individuals incarcerated at time of operation\n* Individuals with known preexisting connective tissue disease\n* Individuals with known preexisting ventral abdominal wall hernia\n* Individuals who are pregnant time of operation\n* Individuals who are deceased prior to conclusion of exploratory laparotomy\n* Individuals lost to follow-up or deceased during the first 30 days after laparotomy.","ALL","18 Years","100 Years",{"count":85,"type":86},250,"ESTIMATED","INTERVENTIONAL",[89],"NA","This randomized control trial aims to compare the efficacy of triclosan-coated barbed suture (TCB) versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abdominal fascia after emergency exploratory laparotomy. The study addresses the common complications of incisional surgical site infections (SSI) and fascial dehiscence (FD) following emergency exploratory laparotomy. The primary objective is to assess the effectiveness of triclosan-coated barbed suture and conventional non-barbed suture in reducing the rates of incisional SSI and FD within 30 days postoperatively. The study population comprises adult patients undergoing emergent laparotomy for traumatic injuries or acute intraabdominal pathology. This prospective, single-blinded randomized control trial will be conducted at Los Angeles General Medical Center. Patients will be randomized to receive either triclosan-coated barbed suture or conventional non-barbed suture for abdominal fascial closure, with a standard closure technique employed. Patients will be followed up for 30 days postoperatively to monitor surgical site infections, fascial dehiscence, and other outcomes. Statistical analysis will be conducted to compare outcomes between the study arms, assessing the efficacy of triclosan-coated barbed suture in reducing the incidence of SSI and FD, along with secondary outcomes.",[92,93,94,95,96],"Laparotomy","Dehiscence Wound","Surgical Site Infections","Trauma Abdomen","Emergency General Surgery",[98,99,100,101,102,103,24],"fascial dehiscence","surgical site infection","laparotomy","ex-lap","STRATAFIX","PDS","NOT_YET_RECRUITING","2023-11-27",{"date":107,"type":108},"2023-11-28","ACTUAL",{"date":110,"type":86},"2024-01-01",{"date":112,"type":86},"2027-01-31",{"name":5,"class":6},1]