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Custom 3D-Printed cap may protect the brain after skull surgery

NCT ID NCT07122752

Symptom relief Sponsor: Tan Tock Seng Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 08, 2026 · Last updated Oct 09, 2026 · Updated 1 time

Summary

After surgery to remove part of the skull, patients need protection for the brain while the skull heals. This study compares two versions of a custom 3D-printed cap: an older model that carers put on and take off under therapist supervision, and a newer one designed to be put on and taken off with one hand while a carer monitors. Researchers will track safety, skin reactions, how many hours a day people wear the cap, and how they rate its appearance.

What this could mean

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

Active substance
a 3D-printed externally applied cranial orthosis (a custom-fit cap worn over the head after skull surgery)
What this could lead to
If the cap proves safe and easy to wear, it could offer a simpler way to protect the brain after decompression surgery, with less reliance on constant carer supervision.
What could go wrong
This is a small retrospective study of 32 people at one hospital, so the findings may not apply broadly. The cap can cause skin redness, pain, or itching, and some patients may not tolerate wearing it.

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.

Participants

32 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Aug 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.

Who is studied

NA as no patient is recruited for this study as the outcomes involve retrospective data as part of a clinical service audit.

Ages

21 years and older

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: * Unilateral decompressive craniectomy (DC) * Acute Stroke or traumatic brain injury * \>30 days post DC * Healed surgical wounds, non-bulging flaps * Presence of caregiver supervision Exclusion Criteria: * Vegetative or minimally responsive state * Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy * Life expectancy \< 6 months * Unhealed or infected post-DC neurosurgical wounds * Known allergy to investigational products

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Conditions

The condition(s) this trial relates to.

brain cancer Brain Injuries, Traumatic brain injury brain neoplasm stroke disorder traumatic brain injury

As listed by the trial registrant

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

Acquired brain injury Brain tumor Stroke Traumatic brain injury

Contacts and locations

Locations

  • Tan Tock Seng Hospital

    Singapore, Singapore

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