CraniSeal vs DuraSeal for Cerebrospinal Fluid Leak

Recruiting at 2 trial locations

Overseen By M Pace

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Pramand LLC

Disqualifiers: Renal, Hepatic, Immune, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

224 Participants Needed

Trial Summary

What is the purpose of this trial?

To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CraniSeal and DuraSeal for cerebrospinal fluid leak?

DuraSeal is a synthetic product used to help create a watertight seal after surgery to prevent cerebrospinal fluid leaks, which can lead to complications like infections. However, while it is commonly used, there are reports of complications such as tissue compression due to its expansion properties. ^{1 2 3 4 5}

Is DuraSeal safe for use in humans?

DuraSeal has been shown to be generally safe for use in humans, but there have been reports of complications such as cord compression in some cases. It is approved by the U.S. Food and Drug Administration for achieving watertight closure in cranial surgeries, and studies have found it to be safe when used with various duraplasty materials. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for adults over 18 who need elective brain surgery involving a dural incision and are able to follow the study's requirements. They must sign an informed consent form and be scheduled for a procedure classified as clean. It's not specified who can't join.

Inclusion Criteria

Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures

Patients who are able to comply with study requirements

I am scheduled for brain surgery that involves cutting the dura.

Exclusion Criteria

I am not pregnant or breastfeeding.

I need a surgery that involves going through the ear, nose, or mouth.

Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT>37 seconds or INR >1.5 units)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CraniSeal or DuraSeal as an adjunct to sutured dural closure following elective cranial surgery

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness, including absence of CSF leaks and treatment emergent adverse events

90 days

Treatment Details

Interventions

• CraniSeal
• DuraSeal

Trial Overview The study compares CraniSeal Dural Sealant with DuraSeal in preventing cerebrospinal fluid (CSF) leaks after elective cranial surgery. The goal is to see if CraniSeal is at least as good as DuraSeal without causing more infections or adverse events.

Participant Groups

Group I: CraniSeal Experimental Treatment 1 Intervention

CraniSeal

Group II: DuraSeal Active Control 1 Intervention

DuraSeal

Who Is Running the Clinical Trial?

Pramand LLC

Lead Sponsor

Trials

1

Recruited

220+

Findings from Research

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]

Current dural sealants are intended to prevent cerebrospinal fluid (CSF) leakage after intradural surgery, but systematic reviews indicate that no significantly effective sealant is currently available.

Future developments in dural sealants may focus on creating products that not only prevent CSF leakage but also possess antimicrobial and analgesic properties, enhancing patient safety and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dural sealants for the management of cerebrospinal fluid leakage after intradural surgery: current status and future perspectives. Kinaci, A., Van Doormaal, TPC.[2019]

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]

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]

Cerebrospinal fluid (CSF) leaks are a common issue after spinal and cranial surgeries, particularly in patients with spinal tumors, highlighting the need for effective closure techniques.

The case reported demonstrates a complication where the DuraSeal® Dural Sealant, used to repair a CSF leak, caused thecal sac compression, indicating that while such sealants are helpful, they can also lead to significant complications if not monitored closely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Thecal Sac Compression Induced by Hydrogel Dural Sealant after Spinal Schwannoma Removal. Han, HJ., Jeong, JH., Kim, JW., et al.[2020]

The DuraSeal dural sealant system is safe and effective for preventing cerebrospinal fluid (CSF) leaks when used with nonautologous duraplasty materials, showing a 7.6% incidence of CSF leakage in a study of 66 patients.

No serious adverse events were reported, and the incidence of meningitis was 0% in the study group, indicating a favorable safety profile compared to a previous trial with autologous materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials. Weinstein, JS., Liu, KC., Delashaw, JB., et al.[2019]

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]

The PEG hydrogel dural sealant demonstrated a safety profile comparable to standard dural sealing techniques, with similar rates of neurosurgical complications, surgical site infections, and cerebrospinal fluid leaks in a study of 237 patients.

This sealant was also significantly faster to prepare and apply, with 96.6% of cases taking less than 5 minutes for preparation and 85.7% taking under 1 minute for application, making it a more efficient option for surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. Osbun, JW., Ellenbogen, RG., Chesnut, RM., et al.[2022]

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]

References

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

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

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

Dural sealants for the management of cerebrospinal fluid leakage after intradural surgery: current status and future perspectives. [2019]

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

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

Postoperative Thecal Sac Compression Induced by Hydrogel Dural Sealant after Spinal Schwannoma Removal. [2020]

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

The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

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

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

A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. [2022]

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

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