VER-01 Sealing Sutured Cranial Dural Repair Study

JRCT ID: jRCT2031230364

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Elective craniotomy or decompressive craniectomy surgery in supratentorial or posterior fossa
• Date of first enrollment: 01/10/2023
• Target sample size: 130
• Study type: Interventional
• Intervention(s): Subjects, who are undergoing sutured dural repair following procedures in the supratentorial region or posterior fossa, will be evaluated for intra-operative cerebrospinal fluid (CSF) leakage with a baseline Valsalva maneuver performed to a pressure between 20-25 cm H2O for 5-10 seconds. If a spontaneous leak is apparent immediately after dural closure, no Valsalva maneuver will be performed. Subjects who have exudative CSF leakage are enrolled will be randomized to VER-01 or Beriplast P in a 1:1 allocation ratio.

Outcome(s)

Primary Outcome

Incidence rate of post-operative CSF leak or pseudomeningocele in the surgical area within 7 days (plus or minus 2 days) following surgery.
Computerized tomography (CT) scan within 5 mm slice thickness is necessary after surgery within 7 days (plus or minus 2 days) following surgery. The imaging is not necessary when CSF leak is visually apparent.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Pre-operative
1.Subjects undergoing an elective craniotomy or decompressive craniectomy surgery in supratentorial or posterior fossa
2.At least 18 years of age at the time of informed consent.
3.Willingness to comply with the protocol.
4.Willingness to give consent before all study-related activities.

Intra-operative
1.Surgical wound classification Class I. Superficial penetration of mastoid air cells during partial mastoidectomy is permitted.
2.The cuff of native dura along the craniotomy edge on each side is adequate, based on judgement of principal investigator or sub-investigator, to facilitate suturing and to allow for sufficient surface area for adherence of the sealant
3.Presence of intra-operative spontaneous cerebrospinal fluid (CSF) leakage following sutured dural closure or after Valsalva maneuver. If a spontaneous leak is apparent immediately after dural closure, no Valsalva maneuver will be performed.

Exclude criteria

Pre-operative
1.Subjects with a cranial dural lesion from a recent surgery that still has the potential for CSF leakage.
2.Chemotherapy scheduled within 30 days prior to enrollment or scheduled within 7 days following surgery.
3.Radiation therapy to the head scheduled within 30 days prior to enrollment or scheduled within 7 days following surgery.
4.Corticosteroids on a chronic basis (more than 6 weeks) unless treatment is discontinued 4 weeks prior to planned surgery
5.Subjects who have intolerance to any of the components of the investigational or comparator products (including bovine-derived ingredients).
6.Subjects who are not willing to use blood products.
7.Subjects with any other pre-operative finding identified by the surgeon that in their opinion, may affect the primary or secondary endpoints such as severely altered renal or hepatic function, compromised immune system, autoimmune disease or uncontrolled/poorly controlled diabetes with the risk of wound healing complication.
8.Subjects who have hydrocephalus (unless hydrocephalus caused by posterior fossa pathology or incompletely open cerebrospinal fluid pathways is treated in this study)
9.Subjects with traumatic injuries to the head with damage to the dura and/or with an existing shunt or drain for decompression.
10.Subjects of childbearing potential with a positive pregnancy test or those who intend to become pregnant during the clinical study period.
11.Subjects who are breastfeeding.
12.Subjects who have participated in or will participate in another clinical trial of another a test drug/device within 30 days of a surgery of the clinical trial.
13.Subjects judged to be inappropriate by the principal investigator or sub-investigator.

Intra-operative
1.Unintentional dural tears during craniotomy/ decompressive craniectomy that cannot be suture repaired.
2.Subject has a gap between durotomy edges of greater than 2 mm after primary dural closure.
3.Use of implants made of synthetic materials that cannot be sutured to dura, shunts, ventricular and subdural drains.
4.Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dural resection.
5.Placement of Gliadel Wafers
6.Two or more separate dural defects.
7.Subjects who have serious complication in surgeries requiring emergency resuscitation or changing of planned surgeries.
8.Subjects judged to be inappropriate by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Deura Imari