[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586804":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":11,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":11,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ertapenem only","EXPERIMENTAL",null,[13],"Drug: Ertapenem",{"label":15,"type":10,"description":11,"interventionNames":16},"Combination of cefazolin and metronidazole.",[17],"Drug: Cefazolin and Metronidazole.",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Ertapenem","Participants will receive a single dose of IV ertapenem (1g) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Cefazolin and Metronidazole.","Participants will receive a single dose of a combination of IV cefazolin (re-dosed during the case every 4 hours and\u002For after every 1,500 mL of blood loss) and IV metronidazole (single dose 500 mg) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status",[15],[29],{"name":30,"affiliation":5,"role":31},"Lillian S Kao, MD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","(713) 500-6280","Lillian.S.Kao@uth.tmc.edu",{"name":38,"role":34,"phone":39,"phoneExt":11,"email":40},"Erin E Fox, PhD","713 500 7965","erin.e.fox@uth.tmc.edu",[42],{"facility":43,"status":11,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-95.36327,29.76328,{"lat":53,"lon":52},[56,58],{"name":30,"role":34,"phone":57,"phoneExt":11,"email":36},"713-500-6280",{"name":38,"role":34,"phone":39,"phoneExt":11,"email":40},{"type":31,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Lillian Kao","Professor",[63],{"name":64,"class":65},"Surgical Infection Society","UNKNOWN","100586804","phase-4-prevention-of-trauma-related-infections-through-an-embedded-clinical-trials-network-100586804",false,"NCT06920147","PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network","PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) Network","PROTECT","Inclusion Criteria:\n\n* Trauma laparotomy within 90 minutes of arrival\n\nExclusion Criteria:\n\n* Patients with a known allergy to cephalosporins or β-lactamase inhibitors\n* Prisoners\n* Pregnant and lactating women","ALL","18 Years",{"count":77,"type":78},300,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The purpose of this study is to compare the effectiveness of 2 prophylactic antibiotic regimens, ertapenem and cefazolin with metronidazole, in preventing organ space surgical site infections (OS-SSI) after emergency trauma laparotomy embedded into routine clinical care and to validate a Bayesian OS-SSI risk calculator using Trauma Quality Improvement Program (TQIP) standardized variables",[84],"Surgical Site Infection","NOT_YET_RECRUITING","2025-04-08",{"date":88,"type":89},"2025-04-11","ACTUAL",{"date":91,"type":78},"2025-05-01",{"date":93,"type":78},"2027-03-31",{"name":5,"class":6},1]