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

Primary Purpose

Cerebrospinal Fluid Leak

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Dura Sealant Patch

About this trial

This is an interventional prevention trial for Cerebrospinal Fluid Leak

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Elisabeth TweeSteden Ziekenhuis
UMCU
University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dura Sealant Patch

Arm Description

Application of Dura Sealant Patch after closure of the dura mater

Outcomes

Primary Outcome Measures

Incidence of wound infection confirmed by increase of CRP and positive cultures

wound infection confirmed by increase of CRP and positive cultures

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

intra-operative CSF leakage

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

Percutaneous CSF leak confirmed by β-2 transferrin test

Secondary Outcome Measures

Full Information

NCT ID

NCT03566602

First Posted

June 12, 2018

Last Updated

September 15, 2020

Sponsor

Polyganics BV

1. Study Identification

Unique Protocol Identification Number

NCT03566602

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 11, 2018 (Actual)

Primary Completion Date

August 31, 2019 (Actual)

Study Completion Date

August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polyganics BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebrospinal Fluid Leak

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dura Sealant Patch

Arm Type

Other

Arm Description

Application of Dura Sealant Patch after closure of the dura mater

Intervention Type

Device

Intervention Name(s)

Dura Sealant Patch

Intervention Description

Adjunctive bioresorbable patch

Primary Outcome Measure Information:

Title

Incidence of wound infection confirmed by increase of CRP and positive cultures

Description

wound infection confirmed by increase of CRP and positive cultures

Time Frame

up to 30 days after surgery

Title

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

Description

intra-operative CSF leakage

Time Frame

intra-operative

Title

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

Description

Percutaneous CSF leak confirmed by β-2 transferrin test

Time Frame

up to 30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Elisabeth TweeSteden Ziekenhuis

City

Tilburg

Country

Netherlands

Facility Name

UMCU

City

Utrecht

Country

Netherlands

Facility Name

University Hospital Zurich

City

Zürich

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

34321304

Citation

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.

Results Reference

derived

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

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