[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546855":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":35,"id":39,"slug":26,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":26,"enrollmentInfo":48,"targetDuration":26,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":26},{"fullName":5,"class":6},"Universiti Sains Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR","Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml",[13],"Device: Normal Saline",{"label":15,"type":16,"description":17,"interventionNames":18},"Study group","EXPERIMENTAL","Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml",[19],"Device: Hydrocyn Aqua®",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Hydrocyn Aqua®","The study solution comes in a liquid form containing hypochlorous acid (HOCl) in a concentration of 0.003%. It is used as a topical agent for wound and peritoneal lavage before wound closure",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal Saline","aqueous solution of electrolytes and other hydrophilic molecules",[9],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dinesh Alagoo","Dr",[36],{"name":37,"class":38},"Hospital Queen Elizabeth, Malaysia","OTHER_GOV","100546855",false,"NCT06400394","Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution","Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution: A Randomised Double-Blind, Placebo-controlled Trial","Plasso 2","Inclusion Criteria:\n\n1. Patients age 13yrs and above\n2. Diagnosed with perforated viscus intraoperatively\n3. Undergo Midline Laparotomy\n4. ASA 3 and below\n\nExclusion Criteria:\n\n1. Surgical technique: Laparoscopic washouts\n2. Patients on steroid treatment and immunosuppressant therapy.\n3. More than ASA 3\n4. Inability to give\u002Funderstand informed consent\n5. Revision-surgery (previous abdominal surgery within the last 30 days)\n6. Planned re-laparotomy within 30 days\n7. Terminal kidney failure requiring dialysis\n8. Concurrent abdominal wall infections","ALL","13 Years",{"count":49,"type":50},116,"ESTIMATED","INTERVENTIONAL",[53],"NA","This is randomised double blinded placebo-controlled parallel-group study. Patients in Hospital Queen Elizabeth, Sabah and Hospital Universiti Sains Malaysia, Kelantan who undergo laparotomy for peritonitis will be equally randomised into two groups : intervention group receiving super-oxidised solution and the control group receiving normal saline during peritoneal and wound lavage.\n\nThis is a superiority study assessing the effectiveness of the intervention. The patient and doctors directly involved in the partient care will be blinded in this study",[56],"Surgical Site Infection",[58],"\"Peritonitis\" \"Peritoneal lavage\" \"surgical site infection\" \"super-oxidised solution\"","NOT_YET_RECRUITING","2024-08-01",{"date":62,"type":63},"2024-08-06","ACTUAL",{"date":65,"type":50},"2024-09-01",{"date":67,"type":50},"2026-05-01",{"name":5,"class":6}]