[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635064":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":43,"locations":51,"responsibleParty":73,"collaborators":34,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":34,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":34,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":103,"overallStatus":119,"whyStopped":34,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Assiut University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Topical Vancomycin Powder (TVP) Group","EXPERIMENTAL","Patients in this arm will undergo the standard surgical procedure for ventriculoperitoneal (VP) shunt insertion. In addition to standard perioperative intravenous (IV) antibiotic prophylaxis, sterile crystalline Vancomycin powder will be applied directly into Cranial Site (1\u002F3): Around the reservoir and burr hole Tunnel Path (1\u002F3): Dispersed along the subcutaneous track. Abdominal Site (1\u002F3): At the peritoneal entry before closure.",[13,14],"Drug: Topical Vancomycin Powder","Procedure: Standard Perioperative Care",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Patients in this arm will undergo the standard surgical procedure for ventriculoperitoneal (VP) shunt insertion with routine perioperative intravenous (IV) antibiotic prophylaxis only. No topical antibiotics will be applied during the procedure.",[14],[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Topical Vancomycin Powder","Intraoperative Topical Vancomycin Application\n\n1. Preparation and Material Pure vancomycin hydrochloride powder, sourced from conventional vials intended for intravenous reconstitution, will be utilized. The vials shall be opened under strictly sterile conditions within the operative field immediately prior to wound closure to ensure maximum potency and sterility.\n2. Dosage Stratification\n\n   To ensure therapeutic efficacy while maintaining a high safety profile, the dosage is stratified based on the patient's age and anatomical considerations:\n   * Older Children (1 to 18 years): A standardized dose of 1 gram (1000 mg) will be applied.\n   * Infants and Neonates (under 1 year): A weight-adjusted or reduced dose of 500 mg (0.5 grams) will be administered to accommodate the limited subgaleal and subcutaneous volume and to prevent potential local tissue irritation.\n3. Application Technique (The \"Dusting\" Method) The application will follow a systematic \"dusting\" protocol to achieve a high",[9],[27,28],"Vancomycin Hydrochloride","TVP",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Standard Perioperative Care","\"Patients receive the standard institutional protocol for VP shunt insertion, which includes preoperative and postoperative intravenous antibiotic prophylaxis and standard surgical technique without the application of topical antibiotic powder.\"",[16,9],null,[36,40],{"name":37,"affiliation":38,"role":39},"Romany Naguib Said, MBBCh","Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":38,"role":42},"Mahmoud H Ragab, MD","STUDY_CHAIR",[44,48],{"name":37,"role":45,"phone":46,"phoneExt":34,"email":47},"CONTACT","+201202700744","romany.17289966@med.aun.edu.eg",{"name":41,"role":45,"phone":49,"phoneExt":34,"email":50},"+201004001789","ragabm@aun.edu.eg",[52],{"facility":38,"status":34,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Asyut","Asyut Governorate","71515","Egypt","EG",{"type":59,"coordinates":60},"Point",[61,62],31.18368,27.18096,{"lat":62,"lon":61},[65,66,68,69,71],{"name":37,"role":45,"phone":46,"phoneExt":34,"email":47},{"name":67,"role":45,"phone":49,"phoneExt":34,"email":50},"Mahmoud Hassan Ragab, MD",{"name":37,"role":39,"phone":34,"phoneExt":34,"email":34},{"name":41,"role":70,"phone":34,"phoneExt":34,"email":34},"SUB_INVESTIGATOR",{"name":72,"role":70,"phone":34,"phoneExt":34,"email":34},"Abdelhakeem Essa, MD",{"type":39,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Romany Naguib Said Boulos","Resident Doctor of Neurosurgery Department , Faculty of Medicine ,Assiut University","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":86,"type":87},164,"ESTIMATED","INTERVENTIONAL",[90],"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",[93,94,95,96,97,98,99,100,101,102],"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",[23,104,105,94,106,107,108,109,110,111,112,113,114,115,116,117,118],"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":122,"type":123},"2026-04-23","ACTUAL",{"date":125,"type":87},"2026-05",{"date":127,"type":87},"2027-12",{"name":5,"class":6},1]