What side effects are associated with this type of intervention?

Common side effects of dural sealants used to prevent cerebrospinal fluid (CSF) leakage include local inflammation, infection, and allergic reactions. There may also be risks of adhesion formation and potential interference with normal healing processes. In some cases, patients might experience headaches or neurological symptoms if the sealant does not effectively prevent CSF leakage.

What prior FDA approvals exist?

FDA-approved treatments for cerebrospinal fluid (CSF) leaks include various dural sealants and patches designed to prevent leakage following cranial surgery. Products like fibrin glue, which contains plasma-derived clotting proteins, and other synthetic sealants such as polyethylene glycol hydrogel (PEGH) have been used to effectively seal dural defects. These treatments work by creating a barrier that prevents CSF from leaking through surgical sites. The LIQOSEAL® dural sealant, currently under study, aims to provide a similar function by reducing intra- and post-operative CSF leakage, showing promise in clinical trials for its safety and efficacy.

What other types of research exist?

Promising alternatives to LIQOSEAL® for preventing CSF leakage include DuraSeal® and TachoSil®. DuraSeal® is a hydrogel-based sealant that has been widely used and shown to be effective in reducing CSF leaks. TachoSil® is a fibrin sealant patch that has demonstrated efficacy in various surgical settings, including neurosurgery, for sealing dural defects and preventing CSF leakage.

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Sealant Patch

Sealant Patch for Cerebrospinal Fluid Leak (ENCASE-II Trial)

N/A

Waitlist Available

Research Sponsored by Polyganics BV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing LIQOSEAL®, a product that helps seal brain surgery sites to prevent fluid leaks, in patients having elective brain surgery. It works like a patch to stop brain fluid from escaping through the surgical wound.

Who is the study for?

This trial is for adults over 18 who can consent and follow the study plan. Women must use birth control if they can have children. Participants need a clean surgical wound and at least 5mm of dural space around the opening. Excluded are those with certain dural diseases, MRI issues, high infection risk, recent other trials participation, large dural openings, LIQOSEAL® history or allergies to it.

What is being tested?

The trial tests LIQOSEAL®'s ability to prevent cerebrospinal fluid (CSF) leaks after brain surgery compared to DuraSeal and Adherus. It aims to show that LIQOSEAL® is not worse than the controls in stopping CSF leaks post-operation.

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include allergic reactions to patch components, complications from improper sealing leading to CSF leakage which could result in headaches or infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational armExperimental Treatment1 Intervention

Application of LIQOSEAL after closure of dura mater

Group II: Control armActive Control1 Intervention

Application of Adherus or DurSeal after closure of dura mater

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LIQOSEAL

2021

N/A

~230

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for cerebrospinal fluid (CSF) leaks involve the use of dural sealants, such as LIQOSEAL®, which work by creating a watertight seal over the dural closure to prevent CSF leakage. These sealants typically contain biocompatible materials that adhere to the tissue and promote healing. The mechanism of action is crucial for CSF leak patients as it directly addresses the primary issue of preventing fluid escape, thereby reducing the risk of complications such as infections and promoting faster recovery. Effective sealing of the dura mater ensures that the integrity of the central nervous system is maintained, which is essential for patient outcomes.

The Antiedematous Effect of Exogenous Lactate Therapy in Traumatic Brain Injury: A Physiological and Mechanistic Approach.Comparison of equivolume, equiosmolar solutions of mannitol and hypertonic saline with or without furosemide on brain water content in normal rats.Causes of arachnoid cyst development and expansion.