[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544053":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":63,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Loma Linda University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation","EXPERIMENTAL","Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.",[13],"Drug: Povidone-Iodine",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation","ACTIVE_COMPARATOR","Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution.",[19],"Drug: Normal Saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Povidone-Iodine","Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of dilute aqueous povidone-iodine solution allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the povidone-iodine solution then wash-out with 2L of normal saline followed by suctioning of the normal saline.\n\nWound Irrigation: With the fascia closed, the wound will be irrigated with 500mL povidone-iodine solution, suctioned, then washed-out with 500 mL normal saline.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal Saline","Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of normal saline allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the solution, wash-out with 2L of normal saline, followed by suctioning of the normal saline.\n\nWound Irrigation: With the fascia closed, the wound will be irrigated with 500mL normal saline solution, suctioned, then washed-out with 500 mL normal saline.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Martin G Rosenthal, MD","CONTACT","909-558-4000","mrosenthal@ll.edu",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Mohamed H El-Farra, MD","melfarra@llu.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Loma Linda University Health","RECRUITING","Loma Linda","California","92354","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-117.26115,34.04835,{"lat":53,"lon":52},[56,58,61],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":57},"mrosenthal@llu.edu",{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Martin Rosenthal, MD","PRINCIPAL_INVESTIGATOR",{"name":38,"role":62,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100544053","phase-3-diluted-aqueous-povidone-iodine-compared-to-saline-to-decrease-surgical-site-infections-100544053",false,"NCT06363877","Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections","Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections","Inclusion Criteria:\n\n* 18 to 80 years of age\n* undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds\n\nExclusion Criteria:\n\n* Pregnancy\n* Preoperative abdominal wall skin\u002Fsoft tissue infection\n* Iodine allergy\n* Patients unlikely to survive beyond 30 days\n* Patients with mesh placement or placement of a foreign body except for drains","ALL","18 Years","80 Years",{"count":76,"type":77},1100,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds.",[83],"Surgical Site Infection",[85,86,23,28,87,88,89],"Intraoperative Wound Irrigation","Intraoperative Peritoneal Lavage","Exploratory Laparotomy","Clean Contaminated Wounds","Contaminated Wounds","2025-11-17",{"date":92,"type":93},"2025-11-19","ACTUAL",{"date":95,"type":93},"2024-06-03",{"date":97,"type":77},"2026-11",{"name":5,"class":6},1]