Sealant Patch for Cerebrospinal Fluid Leak

(ENCASE-II Trial)

Recruiting at 18 trial locations

Overseen By Andrew Carlson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Polyganics BV

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Hydrocephalus, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

228 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have impaired blood clotting due to medication, you may not be eligible to participate.

What data supports the effectiveness of the treatment Sealant Patch for Cerebrospinal Fluid Leak?

Research shows that the Liqoseal patch, part of the treatment, creates a strong watertight seal in models simulating cranial and spinal conditions, with higher burst pressure compared to other sealants like Adherus and Duraseal. Additionally, Adherus has been found to be a safe alternative to Duraseal in skull base surgeries, with no cerebrospinal fluid leaks observed in studies. ^{1 2 3 4 5}

How is the treatment for cerebrospinal fluid leak using Adherus, DuraSeal, and LIQOSEAL different from other treatments?

LIQOSEAL is unique because it combines a watertight polyesterurethane layer with an adhesive layer, providing a stronger seal compared to other treatments like Adherus and DuraSeal, especially in cranial and spinal models. It maintains a watertight seal for longer periods under physiological conditions, which may reduce complications like cerebrospinal fluid leakage after surgery. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Subjects who are able to provide written informed consent prior to participating in the clinical investigation

Subjects who are able to comply with the follow-up or other study requirements

Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery

Exclusion Criteria

You have any kind of disease in the area where the dura will be closed.

You cannot have an MRI for medical reasons.

You are at risk of being harmed by an increase in PEEP (positive end-expiratory pressure).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo elective cranial intradural surgery with application of either LIQOSEAL or control sealant to reduce CSF leakage

1 week

Post-operative Monitoring

Participants are monitored for intra- and post-operative CSF leakage to assess safety and effectiveness

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Adherus
• DuraSeal
• LIQOSEAL

Trial Overview 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.

Participant Groups

Group I: Investigational arm Experimental Treatment 1 Intervention

Application of LIQOSEAL after closure of dura mater

Group II: Control arm Active Control 1 Intervention

Application of Adherus or DurSeal after closure of dura mater

Who Is Running the Clinical Trial?

Polyganics BV

Lead Sponsor

Trials

6

Recruited

450+

Findings from Research

Liqoseal, a new dural sealant patch, demonstrated significantly higher acute burst pressure compared to other sealants like Adherus, Duraseal, and Tachosil, indicating its superior ability to prevent cerebrospinal fluid leakage after surgery.

In both cranial and spinal models, Liqoseal maintained dural attachment under physiological conditions for up to 72 hours, showcasing its potential effectiveness in sealing dural defects during surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ex vivo evaluation of a multilayered sealant patch for watertight dural closure: cranial and spinal models. Kinaci, A., van Thoor, S., Redegeld, S., et al.[2022]

In a retrospective review of five cases of cerebrospinal fluid (CSF) leaks repaired with the DuraSeal Sealant System, four repairs were successful, indicating its efficacy in enhancing graft strength and forming a watertight seal during endoscopic skull-base surgery.

There were no complications associated with the use of DuraSeal, and its failure rate was comparable to that of Tisseel Fibrin Sealant, suggesting that DuraSeal is a safe and effective option for CSF leak repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of duraseal in repair of cerebrospinal fluid leaks. Chin, CJ., Kus, L., Rotenberg, BW.[2014]

Adherus dural sealant demonstrated a strong safety profile in endoscopic skull base surgery, with no reported postoperative cerebrospinal fluid leaks or other serious complications in a study of 26 patients, similar to a control group using DuraSeal.

Adherus was more easily identifiable on immediate postoperative MRI compared to DuraSeal (50% vs. 20.8%), while both sealants showed comparable quality of life outcomes as measured by SNOT-22 scores, suggesting Adherus is a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherus Dural Sealant in Endoscopic Skull Base Surgery: Safety, Imaging Characteristics, and Sinonasal Quality of Life. Soneru, CP., Riley, CA., Minkowitz, S., et al.[2021]

DuraSeal® is a synthetic product used to help prevent cerebrospinal fluid (CSF) leakage after cranial and spinal surgeries, which can lead to complications like delayed healing and infections.

However, there is a risk associated with its use, as demonstrated by a case where a patient experienced cord compression due to the expansion of DuraSeal® following cervical spine surgery, highlighting the need for careful consideration in its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Cervical Cord Compression Induced by Hydrogel Dural Sealant (DuraSeal®). Lee, SH., Park, CW., Lee, SG., et al.[2022]

DuraSeal, a dural sealant used to repair tiny durotomies during surgery, can expand significantly and potentially cause complications, such as nerve root compression, if not used cautiously.

In a case involving a 77-year-old woman, the use of DuraSeal after an intraoperative durotomy led to serious postoperative neurological issues, highlighting the need for careful monitoring of patients for signs of cauda equina syndrome following its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cauda equina syndrome caused by the application of DuraSealTM in a microlaminectomy surgery: A case report. Yeh, KL., Wu, SH., Fuh, CS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ex vivo evaluation of a multilayered sealant patch for watertight dural closure: cranial and spinal models. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Use of duraseal in repair of cerebrospinal fluid leaks. [2014]

4. Germany pubmed.ncbi.nlm.nih.gov

Adherus Dural Sealant in Endoscopic Skull Base Surgery: Safety, Imaging Characteristics, and Sinonasal Quality of Life. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

First impressions about Adherus, a new dural sealant. [2018]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Postoperative Cervical Cord Compression Induced by Hydrogel Dural Sealant (DuraSeal®). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cauda equina syndrome caused by the application of DuraSealTM in a microlaminectomy surgery: A case report. [2022]