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Cow collagen patch under scrutiny in brain surgery safety trial

NCT ID NCT07118020

Disease control Sponsor: RTI Surgical 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is checking how safe a patch called Tutopatch is when used in skull surgery. The patch is made from cow collagen and helps cover the brain after the skull is opened. Researchers will track problems like fluid leaks or the need for another surgery in 75 patients. The goal is to see if the patch is safe enough for regular use.

What this could mean

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

Active substance
Tutopatch (a patch made from cow collagen used to cover the brain after skull surgery)
What this could lead to
If successful, this study could confirm that Tutopatch is a safe option for covering the brain after skull surgery, potentially reducing complications.
What could go wrong
This is a small, early-stage safety study with no comparison group, so it cannot prove the patch works better than other methods. Risks include allergic reaction to cow collagen or infection.

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

About 75 people

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

Started

Sep 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants in this study will be candidates for craniotomy due to tumor, aneurysm, trauma or other medical conditions recruited from the participating investigator's population

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Males and females of any age undergoing craniotomy * Able to return for scheduled study visits * Informed consent is able to be obtained Exclusion Criteria: * Life expectancy \< 12 months * Local cerebral infection * Previous surgery at same anatomical site * Currently enrolled in another study that would affect validity of study * Known hypersensitivity to bovine collagen

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As listed by the trial registrant

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

Craniotomy

How to take part

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

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Hospital Universitari Vali d'Hebron

    Barcelona, Spain

  • Universitatsklinik fur Neurochirurgie der PMU

    Salzburg, Austria

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