[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ventriculoperitoneal-shunt-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ventriculoperitoneal-shunt-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100635064","phase-4-efficacy-and-cost-effectiveness-of-topical-vancomycin-powder-in-preventing-pediatric-ventriculoperitoneal-shunt-infections-across-different-etiologies-100635064",false,"NCT07547826","Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies","Inclusion Criteria:\n\nPatients will be enrolled in the study if they meet all the following criteria:\n\n* Age Range: Paediatric patients from birth (neonates) up to 18 years of age.\n* Indication: Patients undergoing primary (first-time) Ventriculoperitoneal (VP) shunt insertion.\n* Aetiology: Hydrocephalus due to congenital causes, post-haemorrhagic, or post-inflammatory origins.\n* Consent: Written informed consent provided by the parents or legal guardians.\n\nExclusion Criteria:\n\nTo ensure that the infection rate is strictly related to the surgical procedure and not to external chronic factors, patients with the following will be excluded:\n\n* Tumor-related Hydrocephalus: Due to the impact of malignancy, chemotherapy-induced immunosuppression, or potential radiotherapy on wound integrity.\n* Co-morbidities: Patients with Diabetes Mellitus, chronic renal failure, or known immunodeficiency disorders (to isolate paediatric physiological response).\n* Active Infection: Clinical or laboratory evidence of systemic sepsis or meningitis at the time of surgery.\n* Hypersensitivity: Known history of allergy to Vancomycin.\n* Revision Surgery: Patients undergoing shunt revision or replacement due to previous infection within the last 3 months.\n* Local Skin Issues: Active dermatitis or infection at any of the planned incision sites.\n* Complex Hydrocephalus: Patients requiring additional concurrent neurosurgical procedures (e.g., tumor biopsy, Chiari decompression, or cyst fenestration) to avoid prolonged operative time as a confounding risk factor for infection.\"","ALL","1 Day","18 Years",{"count":19,"type":20},164,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Objectives\n\n* Primary:\n* To measure the reduction in VP shunt infection rates using topical vancomycin powder.\n* Secondary:\n* To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory).\n* To analyze the microbiological profile of failed cases.\n* To compare the \"Time-to-Infection\" and shunt survival rates between the study and control groups using Kaplan-Meier analysis.\n* To evaluate the cost-effectiveness of TVP compared to the standard management and historical AIC data",[26,27,28,29,30,31,32,33,34,35],"Hydrocephalus","Ventriculoperitoneal Shunt Infection","Surgical Site Infection (SSI)","Cerebrospinal Fluid Shunt Infection","Pediatric Hydrocephalus","Hydrocephalus in Children","Hydrocephalus in Infants","Postoperative Complications","Prosthesis-Related Infections","Bacterial Infections and Mycoses",[37,38,39,27,40,41,42,43,44,45,46,47,48,49,50,51,52],"Topical Vancomycin Powder","Vancomycin Crystalline Powder","Biofilm Prevention","Congenital Hydrocephalus","Post-Hemorrhagic Hydrocephalus","Post-Meningitic Hydrocephalus","Cost-Effectiveness","Resource-Limited Settings","Pediatric Neurosurgery","Antibiotic Stewardship","Surgical Site Infection","Antibiotic-Impregnated Catheters","Cerebrospinal Fluid Shunt","Surgical Wound Infection","VP Shunt Infection","AIC","NOT_YET_RECRUITING","2026-04-17",{"date":56,"type":57},"2026-04-23","ACTUAL",{"date":59,"type":20},"2026-05",{"date":61,"type":20},"2027-12",{"name":63,"class":64},"Assiut University","OTHER"]