Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies

NCT07547826 | Not Yet Recruiting Phase 4

• 1 other identifier: AUN-NS-2026-RN
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives

• Primary:
• To measure the reduction in VP shunt infection rates using topical vancomycin powder.
• Secondary:
• To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory).
• To analyze the microbiological profile of failed cases.
• To compare the "Time-to-Infection" and shunt survival rates between the study and control groups using Kaplan-Meier analysis.
• To evaluate the cost-effectiveness of TVP compared to the standard management and historical AIC data

Conditions

Hydrocephalus; Ventriculoperitoneal Shunt Infection; Cerebrospinal Fluid Shunt Infection; Pediatric Hydrocephalus; Hydrocephalus in Children; Hydrocephalus in Infants; Postoperative Complications; Prosthesis-Related Infections; Bacterial Infections and Mycoses; Surgical Site Infection (SSI)

Keywords

Topical Vancomycin Powder; Vancomycin Crystalline Powder; Biofilm Prevention; Ventriculoperitoneal Shunt Infection; 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

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections

  Evaluation of the efficacy of intraoperative topical Vancomycin powder in reducing the overall rate of shunt-related infections. Shunt infection will be defined based on: 1. Clinical signs (wound discharge, erythema, or peritonitis). 2. Laboratory findings (Positive CSF culture or abnormal CSF biochemistry). 3. radiological evidence of shunt failure 4. Surgical evidence (purulence during revision).

  Within 6 months postoperatively.

Secondary Outcomes (4)

• Efficacy Analysis Stratified by Hydrocephalus Etiology

  Up to 6 months postoperatively

• Time-to-Infection (Shunt Survival Rate).

  Up to 6 months postoperatively.

• Microbiological Profile of Infected Shunts.

  At the time of infection diagnosis (within 6 months postoperatively).

• Cost-Effectiveness Analysis of Topical Vancomycin Powder.

  Up to 6 months postoperatively.

Study Arms (2)

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 (1/3): Around the reservoir and burr hole Tunnel Path (1/3): Dispersed along the subcutaneous track. Abdominal Site (1/3): At the peritoneal entry before closure.

Drug: Topical Vancomycin Powder; Procedure: Standard Perioperative Care

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.

Procedure: Standard Perioperative Care

Interventions

Topical Vancomycin Powder DRUG

Intraoperative Topical Vancomycin Application 1. 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. 2. Dosage Stratification To ensure therapeutic efficacy while maintaining a high safety profile, the dosage is stratified based on the patient's age and anatomical considerations: * Older Children (1 to 18 years): A standardized dose of 1 gram (1000 mg) will be applied. * 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. 3. Application Technique (The "Dusting" Method) The application will follow a systematic "dusting" protocol to achieve a high

Also known as: Vancomycin Hydrochloride, TVP

Topical Vancomycin Powder (TVP) Group

Standard Perioperative Care PROCEDURE

"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."

Control Group; Topical Vancomycin Powder (TVP) Group

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients will be enrolled in the study if they meet all the following criteria:
• Age Range: Paediatric patients from birth (neonates) up to 18 years of age.
• Indication: Patients undergoing primary (first-time) Ventriculoperitoneal (VP) shunt insertion.
• Aetiology: Hydrocephalus due to congenital causes, post-haemorrhagic, or post-inflammatory origins.
• Consent: Written informed consent provided by the parents or legal guardians.

You may not qualify if:

• To 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:
• Tumor-related Hydrocephalus: Due to the impact of malignancy, chemotherapy-induced immunosuppression, or potential radiotherapy on wound integrity.
• Co-morbidities: Patients with Diabetes Mellitus, chronic renal failure, or known immunodeficiency disorders (to isolate paediatric physiological response).
• Active Infection: Clinical or laboratory evidence of systemic sepsis or meningitis at the time of surgery.
• Hypersensitivity: Known history of allergy to Vancomycin.
• Revision Surgery: Patients undergoing shunt revision or replacement due to previous infection within the last 3 months.
• Local Skin Issues: Active dermatitis or infection at any of the planned incision sites.
• 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."

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (18)

• Xu SJ, Liu XL, Shi JP, Shi JX. The Effect of Topical Vancomycin Powder Application on the Rate of Intervertebral Fusion Following Lumbar Fusion: A Retrospective Study. World Neurosurg. 2024 May;185:e1216-e1223. doi: 10.1016/j.wneu.2024.03.059. Epub 2024 Mar 20.

  PMID: 38514028 BACKGROUND

• Khunchamnan S, Sopchokchai I, Sawanyawisuth K, Kitkhuandee A. An Antibiotic Prophylaxis for Prevention of Ventriculoperitoneal Shunt Infection Using Intraventricular Injection and Shunt Soaking with Vancomycin and Gentamicin. Antibiotics (Basel). 2026 Jan 5;15(1):60. doi: 10.3390/antibiotics15010060.

  PMID: 41594097 BACKGROUND

• Abdullah KG, Chen HI, Lucas TH. Safety of topical vancomycin powder in neurosurgery. Surg Neurol Int. 2016 Dec 5;7(Suppl 39):S919-S926. doi: 10.4103/2152-7806.195227. eCollection 2016.

  PMID: 28031984 BACKGROUND

• Ho AL, Cannon JGD, Mohole J, Pendharkar AV, Sussman ES, Li G, Edwards MSB, Cheshier SH, Grant GA. Topical vancomycin surgical prophylaxis in pediatric open craniotomies: an institutional experience. J Neurosurg Pediatr. 2018 Dec 1;22(6):710-715. doi: 10.3171/2018.5.PEDS17719. Epub 2018 Aug 24.

  PMID: 30141749 BACKGROUND

• Youn SB, Hwang G, Kim HG, Kang JS, Kim HC, Oh SH, Kim MK, Chung BS, Rhim JK, Sheen SH. Intrawound Vancomycin Powder Application for Preventing Surgical Site Infection Following Cranioplasty. J Korean Neurosurg Soc. 2023 Sep;66(5):536-542. doi: 10.3340/jkns.2023.0024. Epub 2023 Apr 10.

  PMID: 37032483 BACKGROUND

• Krause M, Mahr CV, Schob S, Nestler U, Wachowiak R. Topical instillation of vancomycin lowers the rate of CSF shunt infections in children. Childs Nerv Syst. 2019 Jul;35(7):1155-1157. doi: 10.1007/s00381-019-04185-1. Epub 2019 May 20.

  PMID: 31111179 BACKGROUND

• Peng Z, Lin X, Kuang X, Teng Z, Lu S. The application of topical vancomycin powder for the prevention of surgical site infections in primary total hip and knee arthroplasty: A meta-analysis. Orthop Traumatol Surg Res. 2021 Jun;107(4):102741. doi: 10.1016/j.otsr.2020.09.006. Epub 2020 Nov 27.

  PMID: 33257290 BACKGROUND

• Strom RG, Pacione D, Kalhorn SP, Frempong-Boadu AK. Lumbar laminectomy and fusion with routine local application of vancomycin powder: decreased infection rate in instrumented and non-instrumented cases. Clin Neurol Neurosurg. 2013 Sep;115(9):1766-9. doi: 10.1016/j.clineuro.2013.04.005. Epub 2013 Apr 23.

  PMID: 23622935 BACKGROUND

• Kahle KT, Kulkarni AV, Limbrick DD Jr, Warf BC. Hydrocephalus in children. Lancet. 2016 Feb 20;387(10020):788-99. doi: 10.1016/S0140-6736(15)60694-8. Epub 2015 Aug 6.

  PMID: 26256071 BACKGROUND

• Javeed F, Mohan A, Wara UU, Rehman L, Khan M. Ventriculoperitoneal Shunt Surgery for Hydrocephalus: One of the Common Neurosurgical Procedures and Its Related Problems. Cureus. 2023 Feb 15;15(2):e35002. doi: 10.7759/cureus.35002. eCollection 2023 Feb.

  PMID: 36938269 BACKGROUND

• Grosfeld JL, Cooney DR. Inguinal hernia after ventriculoperitoneal shunt for hydrocephalus. J Pediatr Surg. 1974 Jun;9(3):311-5. doi: 10.1016/s0022-3468(74)80286-1. No abstract available.

  PMID: 4843985 BACKGROUND

• Kuruoglu T, Altun G, Kuruoglu E, Turan DB, Onger ME. Actions of N-acetylcysteine, daptomycin, vancomycin, and linezolid on methicillin-resistant Staphylococcus aureus biofilms in the ventriculoperitoneal shunt infections: an experimental study. Chin Neurosurg J. 2022 Jul 5;8(1):15. doi: 10.1186/s41016-022-00284-2.

  PMID: 35791005 BACKGROUND

• Bayston R, Ashraf W, Bhundia C. Mode of action of an antimicrobial biomaterial for use in hydrocephalus shunts. J Antimicrob Chemother. 2004 May;53(5):778-82. doi: 10.1093/jac/dkh183. Epub 2004 Mar 31.

  PMID: 15056650 BACKGROUND

• Darouiche RO. Treatment of infections associated with surgical implants. N Engl J Med. 2004 Apr 1;350(14):1422-9. doi: 10.1056/NEJMra035415. No abstract available.

  PMID: 15070792 BACKGROUND

• Hasanpour M, Rezaee H, Samini F, Keykhosravi E. Effects of Intraventricular Vancomycin Administration on the Prevention of Ventricular Shunt Infection. J Neurol Surg A Cent Eur Neurosurg. 2023 Jun 1. doi: 10.1055/a-2104-1461. Online ahead of print.

  PMID: 37263286 BACKGROUND

• Uysal E, Cine HS, Cakaloglu HC. Effectiveness of subgaleal topical vancomycin powder in reducing infection rates and shunt revisions in pediatric ventriculoperitoneal shunt surgery: a promising prophylactic approach. Childs Nerv Syst. 2024 Nov 26;41(1):3. doi: 10.1007/s00381-024-06672-6.

  PMID: 39589542 BACKGROUND

• Lee JK, Seok JY, Lee JH, Choi EH, Phi JH, Kim SK, Wang KC, Lee HJ. Incidence and risk factors of ventriculoperitoneal shunt infections in children: a study of 333 consecutive shunts in 6 years. J Korean Med Sci. 2012 Dec;27(12):1563-8. doi: 10.3346/jkms.2012.27.12.1563. Epub 2012 Dec 7.

  PMID: 23255859 BACKGROUND

• McGirt MJ, Zaas A, Fuchs HE, George TM, Kaye K, Sexton DJ. Risk factors for pediatric ventriculoperitoneal shunt infection and predictors of infectious pathogens. Clin Infect Dis. 2003 Apr 1;36(7):858-62. doi: 10.1086/368191. Epub 2003 Mar 18.

  PMID: 12652386 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus; Surgical Wound Infection; Postoperative Complications; Prosthesis-Related Infections; Bacterial Infections and Mycoses

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Romany Naguib Said, MBBCh

  Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Mahmoud H Ragab, MD

  Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery

  STUDY CHAIR

Central Study Contacts

Romany Naguib Said, MBBCh

CONTACT

+201202700744; romany.17289966@med.aun.edu.eg

Mahmoud H Ragab, MD

CONTACT

+201004001789; ragabm@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: "To minimize bias, this study employs a double-masking protocol. The Outcome Assessors, responsible for clinical and microbiological diagnosis of shunt infections, are blinded to the treatment allocation. Additionally, the Data Analysts/Statisticians will perform the comparative analysis using coded datasets without knowledge of group assignments. The surgical team (Investigators) cannot be blinded due to the nature of the intervention (topical application of powder). Randomization codes will be secured by a third party and only unblinded after the final statistical analysis is completed."
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor of Neurosurgery Department , Faculty of Medicine ,Assiut University

Model Details: \- Stratification \& Block Randomization To ensure a balanced baseline risk, patients will be stratified into three etiologic strata: 1. Stratum 1: Congenital Hydrocephalus. 2. Stratum 2: Post-haemorrhagic Hydrocephalus. 3. Stratum 3: Post-inflammatory (Post-meningitic) Hydrocephalus. Randomization Process: \> Within each stratum, patients will be randomly assigned to either the Control or Vancomycin group in a 1:1 ratio using Permuted Block Randomization. This ensures that at any point during the study, both treatment arms remain balanced across all three aetiologies. . Randomized Interventions * Control Group (50%): Standard perioperative IV antibiotics. * Vancomycin Group (50%): Standard IV antibiotics + Topical Vancomycin Powder. The same type of shunt hardware will be used for all patients in both groups to eliminate manufacturing variability as a confounder.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

EG (1)