Study to Evaluate Safety and Effectiveness of Spinal Sealant

NCT00594035 | Completed Results DMC

• 1 other identifier: DRS-05-001
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Procedure Requiring Dura Incision

Keywords

Spinal procedure; Dura incision

Outcome Measures

Primary Outcomes (1)

• Watertight Dural Closure

  Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.

  Intra-Operative

Study Arms (2)

1

EXPERIMENTAL

Spinal Sealant

Device: Spinal Sealant System

2

ACTIVE COMPARATOR

Standard of care

Device: Standard of care

Interventions

Spinal Sealant System DEVICE

1

Standard of care DEVICE

Standard of care: devices intended to provide a watertight closure

Also known as: (i.e. devices intended to provide a watertight closure)

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (1)

Confluent Surgical, Inc.

Bedford, Massachusetts, 01730, United States

Location

Results Point of Contact

• Title: Director, Medical Affairs
• Organization: Integra LifeSciences

609-275-0500

Study Officials

• Vladimir Scerbin

  Medtronic - MITG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 15, 2008
• Study Start: September 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 7, 2017
• Results First Posted: December 3, 2009

Record last verified: 2017-08

Locations

US (1)