Study to Evaluate Safety & Effectiveness of Spinal Sealant

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

To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Study Overview

• Status: Completed
• Conditions: Cerebrospinal Fluid Leakage, Subdural
• Intervention / Treatment: Other: Standard of Care; Device: Spinal Sealant

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Confluent Surgical, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects scheduled for a spinal procedure that requires a dural incision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Sealant System	Device: Spinal Sealant; Spinal Sealant System
Active Comparator: Standard of Care; Standard of care methods as an adjunct to sutured dural repair	Other: Standard of Care; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)	Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as: A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.	Intra-operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-Operative CSF Leaks	Percentage of participants with CSF leaks within 90 days post-operatively as determined from clinical diagnosis by one of the following methods: CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 90 days post-procedure; or; CSF leak confirmation by diagnostic testing within 90 days post-procedure; or; CSF leak confirmation by clinical evaluation within 90 days post-procedure	90 Days
Incidence of Post-Operative Surgical Site Infections (SSIs)	•Percentage of participants who incur an SSI within 90 days post-procedure determined by clinical diagnosis SSIs were diagnosed and classified in accordance with the Centers for Disease Control (CDC) criteria for evaluation and diagnosis of nosocomial surgical site infections and were classified as one of the following (Superficial, Deep or Organ/Space).	90 Days

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Medtronic - MITG
• Investigators: Study Director: Jen Doyle, Conlfuent Surgical/Covidien

Publications and helpful links

General Publications

• Wright NM, Park J, Tew JM, Kim KD, Shaffrey ME, Cheng J, Choudhri H, Krishnaney AA, Graham RS, Mendel E, Simmons N. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study. Spine (Phila Pa 1976). 2015 Apr 15;40(8):505-13. doi: 10.1097/BRS.0000000000000810.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: March 6, 2007
• First Submitted That Met QC Criteria: March 6, 2007
• First Posted (Estimate): March 7, 2007

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Prevention of CSF leak
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Neurologic Manifestations; Wounds and Injuries; Central Nervous System Infections; Craniocerebral Trauma; Trauma, Nervous System; Perimeningeal Infections; Cerebrospinal Fluid Leak; Subdural Effusion
• Other Study ID Numbers: DS3-06-002