Evaluating Adherus Dural Sealant for Cranial Surgery

• Between 18 and 75 years old
• Scheduled for an elective spinal procedure that will require a planned durotomy
• Requires a procedure involving a Class I/Clean wound (uninfected surgical wound in which no inflammation is encountered)
• Willing and able to provide informed consent and HIPAA authorization
• Willing and able to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests

• Clinically significant hydrocephalus or clinical evidence of altered CSF dynamics
• Pre-existing external lumbar CSF drain or internal CSF shunt
• Previous CSF leak (secondary to trauma, neoplasm, surgery or other etiology)
• Undergoing a Chiari malformation procedure
• Previous spinal procedure in the same anatomical location
• Radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within 10 days post-index procedure
• Spinal metallic implants that may cause significant imaging artifact on the MRI evaluation of the spine
• Metallic implant(s) that are not MRI compatible, or an elective implant of such devices is planned during the study
• Known malignancy or another condition with anticipated survival shorter than 6 months
• Chemotherapy treatment, excluding hormonal therapy, within 3 weeks prior to or planned within 2 weeks after the index procedure
• Received chronic steroid therapy, defined as regular (daily) administration of steroid agent(s) for ≥ 8 weeks, unless discontinued more than 4 weeks prior to the planned index procedure
• Received warfarin, heparin, other anticoagulant agents, aspirin or non-steroid anti-inflammatory agents on a daily basis and pre-surgical, standard-of-care drug washout did not occur
• Compromised immune system or autoimmune disease or is on chronic immunosuppressant agents at baseline
• Systemic infection or evidence of any infection near planned operative site
• Serum creatinine level under 2.0 mg/dL
• Serum total bilirubin less than 2.5 mg/dL at baseline
• Uncontrolled diabetes as evidenced by an HbA1c > 7% prior to surgery
• Known allergy to FD&C Blue #1 and/or FD&C Yellow #5 or any of the constituents of the dural sealants
• Persons who are pregnant, breast-feeding, or intend to become pregnant during the study
• Participation in a clinical trial of another investigational drug or device and has not completed the required follow-up period

Dr. Olasunkanmi is a neurosurgeon specializing in adult deformity and complex spinal surgery. He combines his surgical expertise with advanced equipment to perform surgeries with significant safety and precision. He is active in research with the goal of improving surgical care and physical function. Dr. Olasunkanmi participates in national organizations, including the North American Spine Society as a member of the Minimally Invasive Procedures Committee, Congress of Neurological Surgeons, and American Association of Neurological Surgeons.