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

April 17, 2026 updated by: Romany Naguib Said Boulos, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ventriculoperitoneal (VP) shunt infection remains one of the most formidable challenges in paediatric neurosurgery, with reported incidence rates reaching as high as 11% to 18% in high-volume referral centers (1-5)

These infections lead to catastrophic consequences, including multiple revision surgeries, prolonged hospitalizations, and significant neurodevelopmental morbidity (2,6,7)

Currently, Antibiotic-Impregnated Catheters (AIC) are considered a standard preventive measure in many international guidelines (6,8,9). However, the prohibitive cost and limited accessibility of AICs-especially in resource-limited settings and public healthcare systems-preclude their routine use for every paediatric patient

This economic barrier has necessitated the search for a cost-effective, readily available alternative that provides comparable antimicrobial protection (10-12) Topical Vancomycin Powder (TVP) has emerged as a promising solution.(5,13-16) Unlike systemic prophylaxis, TVP provides an ultra-high local concentration of antibiotics directly at the surgical site, effectively inhibiting biofilm formation-the hallmark of shunt infections (3,17)

Recent high-level evidence has confirmed that TVP is safe for paediatric use, with no reported systemic toxicity or adverse effects on wound healing(18)(19)

While the efficacy of TVP has been observed in various neurosurgical procedures (13-15), there is a lack of prospective, stratified evidence regarding its performance across different hydrocephalus aetiologies when compared to standard non-impregnated shunts.

Most existing literature evaluates vancomycin powder in a generalized cohort. However, post-inflammatory (post-meningitic) and post-hemorrhagic hydrocephalus cases often have a higher baseline risk of infection due to existing CSF changes.

This study uniquely addresses whether the efficacy of topical vancomycin varies across these different etiological strata (congenital - post-inflammatory - post-haemorrhagic hydrocephalus).

Furthermore, clinical outcomes are often confounded by mechanical factors such as distal catheter migration, this study aims to isolate the antimicrobial effect of vancomycin from mechanical shunt failures.

Unlike systemic antibiotics which contribute to global resistance, Topical Vancomycin provides maximal local efficacy with minimal systemic exposure, aligning with modern Antibiotic Stewardship goals to preserve systemic antibiotic potency while protecting surgical hardware (13)(18).

A critical distinction in this study is the use of Vancomycin in its crystalline powder form rather than aqueous irrigation. Comparative studies have demonstrated that while antibiotic irrigation provides a transient clearing of bacteria, it is rapidly absorbed or washed away, failing to maintain the necessary Minimum Inhibitory Concentration (MIC) during the crucial first 24-48 hours of wound healing.

In contrast, Topical Vancomycin Powder (TVP) acts as a sustained-release reservoir, dissolving slowly and maintaining ultra-high local concentrations exactly where the shunt hardware is most vulnerable to biofilm colonization. This 'depot effect' is what gives the powder a superior prophylactic profile over traditional irrigation method.(3)

Therefore, this study aims to evaluate to what extent topical vancomycin powder can effectively reduce infection rates and serve as a financially viable alternative to AICs in the paediatric population.

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71515
        • Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Romany Naguib Said, MBBCh
        • Sub-Investigator:
          • Mahmoud H Ragab, MD
        • Sub-Investigator:
          • Abdelhakeem Essa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Vancomycin Powder (TVP) Group
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

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
Other Names:
  • Vancomycin Hydrochloride
  • TVP
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."
Active Comparator: Control Group
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
"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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections
Time Frame: Within 6 months postoperatively.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Analysis Stratified by Hydrocephalus Etiology
Time Frame: Up to 6 months postoperatively
To evaluate and compare the prophylactic efficacy of topical vancomycin powder across distinct etiological subgroups, specifically congenital, post-inflammatory, and post-hemorrhagic hydrocephalus. This analysis aims to determine if the "depot effect" of the powder varies based on the underlying cause of hydrocephalus.
Up to 6 months postoperatively
Time-to-Infection (Shunt Survival Rate).
Time Frame: Up to 6 months postoperatively.

Shunt 'infection-free survival' will be compared between the intervention and control groups using Kaplan-Meier survival curves.

The statistical significance of differences in survival distribution between the two arms will be assessed using the Log-rank (Mantel-Cox) test.

Time-to-infection will be calculated from the date of the index surgery to the date of confirmed diagnosis of infection."
Up to 6 months postoperatively.
Microbiological Profile of Infected Shunts.
Time Frame: At the time of infection diagnosis (within 6 months postoperatively).
Identification of the causative bacterial species (e.g., Coagulase-negative Staphylococci, S. aureus, Gram-negative bacilli) in failed cases through culture and sensitivity testing of CSF and wound swabs.
At the time of infection diagnosis (within 6 months postoperatively).
Cost-Effectiveness Analysis of Topical Vancomycin Powder.
Time Frame: Up to 6 months postoperatively.

The cost-effectiveness of using topical Vancomycin powder will be calculated using the Incremental Cost-Effectiveness Ratio (ICER) according to the following formula:

ICER = (Cost_Vancomycin - Cost_Control) / (Effect_Vancomycin - Effect_Control)

*Where "Cost" represents the total direct medical costs (shunt hardware, drug cost, and management of complications), and "Effect" represents the infection-free rate in each group. *
Up to 6 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Romany Naguib Said, MBBCh, Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery
  • Study Chair: Mahmoud H Ragab, MD, Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUN-NS-2026-RN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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