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Earlier skull patch may boost brain healing

NCT ID NCT07183540

Disease control Sponsor: The Affiliated Hospital Of Guizhou Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compares repairing a skull defect within 6 weeks versus waiting 3-6 months after the initial surgery. Researchers will track 582 adults to see if earlier repair leads to better neurological recovery and fewer complications. The goal is to find the best timing for this common procedure.

What this could mean

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

Active substance
autologous skull repair surgery
What this could lead to
If it works, this could show that earlier skull repair helps patients recover better and have fewer complications.
What could go wrong
This is an early-stage study with no phase, so results are uncertain. The procedure itself carries risks like infection or poor healing.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 582 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Sep 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

18 to 80 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: 1. Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage. 2. Age 18 - 80 years. 3. The first time for cranial repair. 4. unilateral skull defect. 5. Compliant with recommended decompressive bone flap surgery and autogenous decompressive bone flap after bone flap collection 6. signed the informed consent. Exclusion Criteria: 1. Poor healing of skin flap (active infection, non-healing, necrosis, sinus, thin or poor blood supply, etc.). 2. Fracture of bone flap ≥2 pieces, partial open fracture 3. Intracranial infection before operation. 4. Severe bone metabolic diseases. 5. Long-term use of immunosuppressants. 6. Pregnant or lactating women. 7. Coagulation disorders. 8. Severe cardiopulmonary insufficiency. 9. It is estimated that the CP process cannot be completed within 6 weeks after the bone plate decompression surgery. 10. Skull defect size less than 25cm². 11. Life expectancy less than 1 year. 12. mRS greater than 1 before primary disease. 13. Diabetic patients. 14. Patients who are unable to cooperate with follow-up assessment (e.g. mental illness).

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As listed by the trial registrant

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

Cranial defect

How to take part

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

  1. The places running it

    7 sites. 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

  • Anshun People's Hospital (Ward One)

    Anshun, Guizhou, 561000, China

  • Anshun People's Hospital (Ward Two)

    Anshun, Guizhou, 561000, China

  • Guizhou Provincial Workers' Hospital

    Guiyang, Guizhou, China

  • Neijiang First People's Hospital

    Neijiang, Sichuan, China

  • Qianfengdong Prefecture People's Hospital

    Kaili, Guizhou, China

  • The First People's Hospital of Bijie City

    Bijie, Guizhou, China

  • Zunyi Medical University Affiliated Hospital

    Zunyi, Guizhou, China

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