Study to Evaluate Safety and Effectiveness of Spinal Sealant

Completed · Not applicable

Conditions studied: Spinal Procedure Requiring Dura Incision

In brief

To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.

Key facts

Study ID

NCT00594035

Run by

Integra LifeSciences Corporation

People needed

158

Starts

2005-09-01

Expected to finish

2008-04-01

Last updated by the study team

2017-09-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Confluent Surgical, Inc. — Bedford, Massachusetts, United States

Full record on ClinicalTrials.gov

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