Expired Study
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Bedford, Massachusetts 01730


Purpose:

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.


Study summary:

Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.


Criteria:

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


Study is Available At:


Original ID:

DRS-05-001


NCT ID:

NCT00594035


Secondary ID:


Study Acronym:


Brief Title:

Study to Evaluate Safety and Effectiveness of Spinal Sealant


Official Title:

A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Integra LifeSciences Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

158


Enrollment Type:

Actual


Overall Contact Information

Official Name:Vladimir Scerbin
Study Director
Medtronic - MITG

Study Dates

Start Date:September 2005
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:February 2008
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 7, 2017
First Received Date:January 2, 2008
First Results Date:October 30, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Watertight Dural Closure
Time Frame:Intra-Operative
Safety Issues:False
Description:Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.

Study Interventions

Intervention Type:Device
Name:Spinal Sealant System
Arm Name:1
Intervention Type:Device
Name:Standard of care
Description:Standard of care: devices intended to provide a watertight closure
Arm Name:2
Other Name:(i.e. devices intended to provide a watertight clo

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Standard of care
Study Arm Type:Experimental
Arm Name:1
Description:Spinal Sealant

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Integra LifeSciences Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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