Study to Evaluate Safety and Effectiveness of Spinal Sealant

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 158

Inclusion Criteria

Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation.
Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria)
Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds.

Exclusion Criteria

Active spinal and/or systemic infection
Patient requires additional spinal surgery within the study time period
Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure
Patient has a pre-existing external lumbar CSF drain or internal CSF shunt
Patient is participating in a clinical trial of another investigational device or drug
Patient with creatinine > 2.0 mg/dL
Patient with total bilirubin > 2.5 mg/dL
Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation
Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery
Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or NSAIDS at the time of surgery
Patient receiving warfarin or heparin at the time of surgery
Patient has a diagnosed and documented compromised immune system and/or autoimmune disease
Patient has has chemotherapy treatment within 6 months prior to, or planned during the study
Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure
Patient has known malignancy or other condition with prognosis shorter than 6 months
Patients with documented history of uncontrolled diabetes
Patient requires use of synthetic or non-autologous duraplasty material
Patient has a gap greater than 2mm remaining after primary dural closure
Patient has undergone laminoplasty decompression
Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position
Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level
The investigator determines that participation in the study may jeopardize the safety or welfare of the patient
The investigator determines that the patient should not be included in the study for reason(s) not already specified