Adherus Dural Sealant for Spinal Duraplasty

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Stryker Craniomaxillofacial

No Placebo Group

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.

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.

I am between 18 and 75 years old.

Exclusion Criteria

I am having surgery for Chiari malformation.

I have had surgery on my spine in the same spot before.

I take blood thinners or anti-inflammatory drugs daily and haven't stopped before surgery.

I have an infection in my body or near where I might have surgery.

My skull's membrane defect can't be closed with stitching or grafting.

I have a condition that may shorten my life to under six months.

My surgeon saw a gap larger than 2 mm in my dura or between the dura and the patch material before using the sealant.

My diabetes is not under control, with an HbA1c level above 7%.

I've had chemotherapy (not hormone therapy) within 3 weeks before, or plan to within 2 weeks after a procedure.

I have had or will have radiation therapy at the surgery area within 10 days after a procedure.

I have a weak immune system or an autoimmune disease.

I have a significant fluid buildup in my brain.

I have had a CSF leak in the past due to injury, tumor, surgery, or another cause.

I have had surgery to relieve pressure on my spinal cord.

I had surgery for syringomyelia without a shunt placed in the subarachnoid space.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Adherus Dural Sealant SystemExperimental Treatment1 Intervention

Device: Adherus Dural Sealant, In situ polymerizing sealant

Group II: DuraSeal Exact Dural Sealant SystemActive Control1 Intervention

Device: DuraSeal Exact (P080013b)