Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

Cerebrospinal Fluid Leak Clinical Trial

Official title:

Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566602
• Other study ID #: CIP-1
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: August 26, 2020

Study information

• Verified date: March 2019
• Source: Polyganics BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 26, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Preoperative Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.

Subjects who are = 18 years old. Subjects who are able to comply with the follow-up or other study requirements. Subjects who are planned for an elective intracranial intradural surgery in whom a dural incision of at least 2 cm in length is necessary, which will be closed.

Female subjects of child bearing potential must agree to use any form of contraception from the time of signing the informed consent form through 90 days post-surgery.

Intraoperative Surgical wound classification Class I/Clean. Minimally 5 mm of dural space surrounding dural opening.

Exclusion Criteria:

Preoperative Female subjects who are pregnant or breastfeeding. Subjects with an assumed impaired coagulation due to medication or otherwise. Subjects suspected of an infection requiring antibiotics. Subjects with any type of dural diseases in planned dural closure area. Subjects requiring re-opening of planned surgical area within 90 days after surgery.

Subjects requiring local radiotherapy in planned surgical area. Subjects with a known allergy to any of the components of the Dura Sealant Patch.

Subject who previously participated in this study or any investigational drug or device study within 30 days of screening.

Subjects with a presence of hydrocephalus. Intraoperative Subjects in whom elevation of PEEP or pCO2 has a potential detrimental effect. Subjects who will require a CSF or wound drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.

Primary closure of the dura mater with synthetic, non-autologous or autologous material other than galea.

A gap > 3 mm after primary closure of the dura mater.

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak

Intervention

Device:
• Dura Sealant Patch
Adjunctive bioresorbable patch

Locations

Country	Name	City	State
Netherlands	Elisabeth TweeSteden Ziekenhuis	Tilburg
Netherlands	UMCU	Utrecht
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Polyganics BV

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of wound infection confirmed by increase of CRP and positive cultures	wound infection confirmed by increase of CRP and positive cultures	up to 30 days after surgery
Primary	Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)	intra-operative CSF leakage	intra-operative
Primary	Incidence of percutaneous CSF leak confirmed by ß-2 transferrin test	Percutaneous CSF leak confirmed by ß-2 transferrin test	up to 30 days after surgery