Adherus Dural Sealant for Spinal Duraplasty

Enrolling by invitation at 15 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Craniomaxillofacial

Must not be taking: Anticoagulants, Steroids

Disqualifiers: Hydrocephalus, CSF shunt, Chemotherapy, others

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

Compensation: Varies

Number of Visits: 4

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Adherus Dural Sealant System during spinal surgeries compared to another FDA-approved sealant. The goal is to determine if this new sealant better protects the area where the spinal cord is exposed during surgery. Suitable candidates have a planned spinal surgery involving a durotomy, without infection or previous complications at the surgical site. Individuals with past spinal surgeries or certain implants may not qualify for this trial. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit future spinal surgery patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are on chronic steroid therapy, anticoagulants, or non-steroidal anti-inflammatory drugs, you may need to stop them before surgery as part of standard care.

What prior data suggests that the Adherus Dural Sealant System is safe for spinal duraplasty?

Research has shown that the Adherus Dural Sealant System is generally safe for use in spinal surgeries. One study found it worked successfully 91.2% of the time, closely matching the 90.6% success rate in the comparison group. This indicates the sealant is effective and does not cause serious issues.

Other studies have examined the safety of Adherus in spinal procedures. These studies confirm that the sealant effectively seals the surgical area and does not cause major side effects. Patients have tolerated the sealant well, with no unusual safety concerns reported.

These findings provide strong confidence that the Adherus Dural Sealant System is safe for use in spinal surgeries, similar to the FDA-approved DuraSeal Exact Spinal Sealant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adherus Dural Sealant System because it offers a unique approach to spinal duraplasty. Unlike traditional treatments like DuraSeal, which are already used to seal the dura mater after spinal surgery, Adherus is an in situ polymerizing sealant. This means it forms a protective, leak-proof barrier directly at the application site, potentially reducing the risk of cerebrospinal fluid leaks. Additionally, its formulation is designed to enhance adhesive strength and durability, which could improve surgical outcomes and patient recovery times.

What evidence suggests that the Adherus Dural Sealant System is effective for spinal duraplasty?

Research has shown that the Adherus Dural Sealant System, which participants in this trial may receive, effectively seals the protective layer around the spinal cord during surgery. In one study, it successfully sealed this layer in 91.2% of patients. The DuraSeal Exact Dural Sealant System, another treatment option in this trial, achieved a 90.6% success rate in the comparison group. Adherus effectively creates a watertight seal, crucial for preventing leaks after surgery. This evidence suggests that Adherus can be a reliable option for patients undergoing spinal surgery, offering effectiveness similar to other approved treatments. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 who need elective spinal surgery involving a clean, uninfected wound. Candidates must have re-approximable durotomy edges and be able to attend follow-up visits. Exclusions include altered CSF dynamics, previous leaks or surgeries in the same spot, non-MRI compatible implants, severe health conditions like cancer with less than six months survival expectancy, recent chemotherapy or chronic steroid use without proper wash-out period, certain medication usage without pre-surgical pause, compromised immune systems or infections near the surgical site.

Inclusion Criteria

I am scheduled for a spine surgery that includes opening the dura mater.

I need a procedure for a clean, uninfected wound.

My surgery involves repairing the outer layer of my brain or spinal cord.

Exclusion Criteria

Subject has a known allergy to FD&C Blue #1 and/or FD&C Yellow #5 or any of the constituents of the dural sealants.

I am having surgery for Chiari malformation.

Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal surgery and are treated with either Adherus Dural Sealant or DuraSeal Exact

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at discharge or between postoperative days 1-4, and at 30 and 90 days post-procedure

90 days

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adherus Dural Sealant System
• DuraSeal Exact Dural Sealant System

Trial Overview The study tests Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant against FDA-approved DuraSeal Exact Spinal Sealant in spinal surgeries. The goal is to compare their effectiveness when used during procedures that require sealing of the dura mater (the tough outer membrane covering the brain and spinal cord) after it has been cut open.

How Is the Trial Designed?

Group I: Adherus Dural Sealant System Experimental Treatment 1 Intervention

Device: Adherus Dural Sealant, In situ polymerizing sealant

Group II: DuraSeal Exact Dural Sealant System Active Control 1 Intervention

Device: DuraSeal Exact (P080013b)

Who Is Running the Clinical Trial?

Stryker Craniomaxillofacial

Lead Sponsor

Trials

2

Recruited

220+

Fortrea

Collaborator

Trials

8

Recruited

2,500+

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+

Fortrea

Industry Sponsor

Trials

22

Recruited

5,800+

Covance

Industry Sponsor

Trials

124

Recruited

13,300+

Dr. Paul Kirchgraber

Covance

Chief Executive Officer since 2019

MD

Dr. Robert Dow

Covance

Chief Medical Officer since 2020

MD

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01158378?tab=history&a=1

Safety and Effectiveness of the Adherus Dural Sealant ... The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with ...

2. cmf.stryker.com cmf.stryker.com/products/adherus

Adherus AutoSpray and Adherus AutoSpray ET The overall success rate for the complete case analysis was 91.2% in the Adherus group compared to 90.6% in the control group. Adherus was found to be non- ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20513570

A Study to Evaluate the Safety and Effectiveness ... The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130014b.pdf

summary of safety and effectiveness data (ssed) Prospective, non- controlled, multi- center, clinical feasibility study to evaluate the preliminary safety and effectiveness of the Adherus.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28927211/

A Pivotal Randomized Clinical Trial Evaluating the Safety ... Results: The primary composite endpoint at the 120-d follow-up was achieved in 91.2% of the test sealant group compared with 90.6% of the ...