[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570330":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PVI","ACTIVE_COMPARATOR",null,[13],"Drug: PVI",{"label":15,"type":10,"description":11,"interventionNames":16},"Usual Care",[17],"Drug: Usual Care",[19,23],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","After removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL\u002Fkg of 1% PVI (up to a maximum of 1,000 mL) will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned out",[9],{"type":20,"name":15,"description":24,"armGroupLabels":25,"otherNames":11},"Surgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (\\\u003C100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation.",[15],[27],{"name":28,"affiliation":5,"role":29},"Dalya Ferguson, MD, MS","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Dalya M Ferguson, MD, MS","CONTACT","(713) 566-5098","Dalya.M.Ferguson@uth.tmc.edu",{"name":37,"role":33,"phone":34,"phoneExt":11,"email":38},"Debbie Nguyen","Debbie.F.Lew@uth.tmc.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-95.36327,29.76328,{"lat":52,"lon":51},[55,57],{"name":28,"role":33,"phone":56,"phoneExt":11,"email":35},"(713) 500-7640",{"name":37,"role":33,"phone":34,"phoneExt":11,"email":38},{"type":29,"investigatorFullName":32,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Assistant Professor",[61],{"name":62,"class":63},"National Center for Advancing Translational Sciences (NCATS)","NIH","100570330","phase-4-appi-cost-trial-for-perforated-appendicitis-100570330",false,"NCT06705842","APPI-Cost Trial for Perforated Appendicitis","The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis","Eligibility for Enrollment\n\nInclusion Criteria:\n\n* Plan to undergo appendectomy for acute appendicitis\n\nExclusion Criteria:\n\n* Preoperative hemodynamic instability requiring ongoing infusion of vasopressors\n* Allergy to iodine\n* Uncontrolled hyper- or hypothyroidism\n* Renal dysfunction\n* Pregnant or breastfeeding\n* Primary language neither English nor Spanish\n* Lack of functioning telephone or email account\n* Incarcerated or in police custody\n\nEligibility for Randomization\n\nInclusion Criteria:\n\n* Enrolled in study preoperatively\n* Intraoperative diagnosis of perforated appendicitis\n\nExclusion Criteria:\n\n* Non-perforated appendicitis","ALL","18 Years",{"count":74,"type":75},346,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.",[81],"Perforated Appendicitis",[81,83,84,85,86,87],"Povidone Iodine","Cost effectiveness","Intra-abdominal abscess","Appendectomy","Implementation science","2025-12-04",{"date":90,"type":91},"2025-12-11","ACTUAL",{"date":93,"type":91},"2025-04-07",{"date":95,"type":75},"2027-03-31",{"name":5,"class":6},1]