Cerebrospinal Fluid Leakage
Conditions
Keywords
Dura, Sealant, Cranial, Craniotomy, CSF leakage, CSF leakage following cranial surgery
Brief summary
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.
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.
Interventions
DEVICEI-020805
A thin layer of I-020805 applied up to two times on the sutured dura mater
Sponsors
Kuros Biosurgery AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance of I-020805 in prevention of CSF leakage | Intraoperative on the day of sugery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of CSF leakage | Within 7 days after surgery or prior to discharge |
| 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 |
| Surgical infection and unexpected neurological signs | Post-operative and within 7 days and 90 following surgery |
Countries
Germany, Hungary
Outcome results
None listed