Adherus Dural Sealant for Spinal Duraplasty

Recruiting 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

114 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures. This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.

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 data supports the effectiveness of the treatment Adherus Dural Sealant System for spinal duraplasty?

Research shows that Adherus Dural Sealant is a safe alternative to other sealants in surgeries, with no cerebrospinal fluid leaks observed in studies. It has been used effectively in neurosurgical procedures to prevent fluid leakage, suggesting it could be beneficial for spinal duraplasty as well. ^{1 2 3 4 5}

Is Adherus Dural Sealant safe for use in humans?

Adherus Dural Sealant has been studied in various surgeries, including skull base and posterior fossa surgeries, and appears to be safe with no significant increase in complications like cerebrospinal fluid leaks or other adverse effects compared to other sealants. ^{1 2 3 5 6}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

References

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

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

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

Use of a novel absorbable hydrogel for augmentation of dural repair: results of a preliminary clinical study. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

Enhanced Dural Repair Using Biodegradable Sealants Based on Photocurable Hyaluronic Acid. [2023]

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

Cerebrospinal Fluid Leaks and Pseudomeningocele after Posterior Fossa Surgery: Effect of an Autospray Dural Sealant. [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]