Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy

A Prospective, Open, Multi-center, Single-arm Study of the Performance and Safety of I-020805 in the Prevention of Cerebrospinal Fluid Leakage Following Elective Cranial Surgery

This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.

Study Overview

• Status: Completed
• Conditions: Cerebrospinal Fluid Leakage
• Intervention / Treatment: Device: I-020805

Detailed Description

Patients who consented to participate in the trial and fulfilled the preoperative inclusion and exclusion criteria underwent screening prior to surgical treatment. After dural suturing, if patients met the intra operative inclusion and exclusion criteria, they received I-020805. If necessary, autologous grafts were to be used to augment dural closure.

I-020805 was delivered from a double syringe applicator that creates a fine layer over the dura. This layer quickly sets within seconds to form a watertight seal.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charite Universitätsmedizin (01)
• Hungary
  • Budapest, Hungary, 1145
    • Orszagos Idegtudomanyi Intezet (11)
  • Debrecen, Hungary, 4023
    • Debreceni Tudomanyegyetem (12)
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem (10)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Pre-operative

• Male or female of 18 years old or over
• Elective cranial procedure entailing a dural incision of at least 2 cm in length
• Requires a procedure involving surgical wound classification Class I/Clean
• Signed informed consent form
• Negative pregnancy test at screening for women of childbearing potential and agreeing to use an acceptable birth control method or abstinence until 90 days post-surgery

Intra-operative

• Surgical wound classification Class I/Clean
• Dural margin from bony edges of at least 3 mm throughout
• Spontaneous expression of CSF assessed visually or a CSF leakage upon Valsalva maneuver

Exclusion Criteria:

Pre-operative

• Cranial procedure requiring translabyrinthine, transoral and/or any procedure penetrating the air sinus or mastoid air cells
• Presence of symptomatic hydrocephalus
• Pre-existing external ventricular drainage or lumbar CSF drain
• Radiotherapy in the planned surgical region which ended within 3 months prior to planned surgery
• Presence of systemic infection
• Known history of hemophilia or other clinically significant coagulopathy
• Known oral anticoagulant use
• Pregnancy or breast feeding
• Known allergy to any components of I-020805
• Previous participation in this trial or any investigational drug or device study within 30 day of screening
• Known clinically significant organ or systemic diseases
• Known or suspected non-compliance with trial procedures

Intra-operative

• Patient not meeting the pre-operative eligibility criteria
• Not able to tolerate a Valsalva maneuver
• Gap of more than 2 mm remaining after primary closure of dura
• Use of synthetic or non-autologous duraplasty material

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-020805; This was a prospective, open, multi-center, single-arm study to investigate I-020805 in patients following elective cranial surgery. If they met the inclusion/ exclusion criteria, they receive I-020805 after suturing of the dura. If necessary, autologous grafts were to be used to augment dural closure.	Device: I-020805; A thin layer of I-020805 applied up to two times on the sutured dura mater

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance of I-020805 in prevention of CSF leakage	Intraoperative on the day of sugery

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of CSF leakage	Within 7 days after surgery or prior to discharge
CSF leakage or pseudomeningocele related surgical intervention	Within 90 days following surgery
CSF leakage confirmed by clinical evaluation or diagnostic testing	Within 90 days following surgery
Surgical infection and unexpected neurological signs	Post-operative and within 7 days and 90 following surgery
Wound healing impairment	Throughout study up to 90 days following surgery
Incidence of all and treatment emergent adverse events	Throughout study up to 90 days following surgery

Collaborators and Investigators

• Sponsor: Kuros Biosurgery AG

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 25, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Craniotomy; CSF leakage; Sealant; Dura; Cranial; CSF leakage following cranial surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cerebrospinal Fluid Leak
• Other Study ID Numbers: CS I-020805/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No