Study to Evaluate Safety & Effectiveness of Spinal Sealant

NCT ID: NCT00444067

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-08-31

Brief Summary

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

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.

Conditions

Cerebrospinal Fluid Leakage, Subdural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spinal Sealant System

Spinal Sealant System

Group Type: EXPERIMENTAL

Spinal Sealant

Intervention Type: DEVICE

Spinal Sealant System

Standard of Care

Standard of care methods as an adjunct to sutured dural repair

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of Care

Interventions

Spinal Sealant

Spinal Sealant System

Intervention Type: DEVICE

Standard of Care

Standard of Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jen Doyle

Role: STUDY_DIRECTOR

Conlfuent Surgical/Covidien

Locations

Confluent Surgical, Inc.

Bedford, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25646746 (View on PubMed)

Other Identifiers

DS3-06-002

Identifier Type: -

Identifier Source: org_study_id