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Could a sprinkle of antibiotic powder stop brain shunt infections in kids?

NCT ID NCT07547826

Prevention Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether applying vancomycin powder directly into the surgical wound during shunt placement can prevent infections in children with hydrocephalus. About 164 children will be randomly assigned to receive either standard care or standard care plus the powder. The goal is to see if this simple step reduces infection rates and is cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vancomycin powder
What this could lead to
If it works, this could provide a simple, cheap way to prevent serious infections after shunt surgery in children.
What could go wrong
This is a single-center trial with 164 children, so results may not apply everywhere. Vancomycin powder might not reduce infections significantly, and there is a risk of antibiotic resistance or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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."

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Conditions

The condition(s) this trial relates to.

Bacterial Infections and Mycoses hydrocephalus Postoperative Complications prosthesis-related infectious disease Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacterial infections and mycoses Cerebrospinal fluid shunt infection Hydrocephalus Hydrocephalus in children Hydrocephalus in infants Pediatric hydrocephalus Postoperative complications Prosthesis related infections Surgical site infection (SSI) Ventriculoperitoneal shunt infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Asyut, Asyut Governorate, 71515, Egypt

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