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

NCT03566602 | Completed

• 1 other identifier: CIP-1
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Cerebrospinal Fluid Leak

Outcome Measures

Primary Outcomes (3)

• 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

• Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)

  intra-operative CSF leakage

  intra-operative

• Incidence of percutaneous CSF leak confirmed by β-2 transferrin test

  Percutaneous CSF leak confirmed by β-2 transferrin test

  up to 30 days after surgery

Study Arms (1)

Dura Sealant Patch

OTHER

Application of Dura Sealant Patch after closure of the dura mater

Device: Dura Sealant Patch

Interventions

Dura Sealant Patch DEVICE

Adjunctive bioresorbable patch

Dura Sealant Patch

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polyganics BV: lead

Study Sites (3)

Elisabeth TweeSteden Ziekenhuis

Tilburg, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• Van Doormaal T, Germans MR, Sie M, Brouwers B, Carlson A, Dankbaar JW, Fierstra J, Depauw P, Robe P, Regli L. Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial. BMJ Open. 2021 Jul 28;11(7):e049098. doi: 10.1136/bmjopen-2021-049098.

  PMID: 34321304 DERIVED

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: October 11, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 26, 2020
• Last Updated: September 16, 2020

Record last verified: 2019-03

Locations

NL (2); CH (1)