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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03566602
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : September 5, 2018
Information provided by (Responsible Party):
Polyganics BV

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.

Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Leak Device: Dura Sealant Patch Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Dura Sealant Patch
Application of Dura Sealant Patch after closure of the dura mater
Device: Dura Sealant Patch
Adjunctive bioresorbable patch

Primary Outcome Measures :
  1. Incidence of wound infection confirmed by increase of CRP and positive cultures [ Time Frame: up to 30 days after surgery ]
    wound infection confirmed by increase of CRP and positive cultures

  2. Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP) [ Time Frame: intra-operative ]
    intra-operative CSF leakage

  3. Incidence of percutaneous CSF leak confirmed by β-2 transferrin test [ Time Frame: up to 30 days after surgery ]
    Percutaneous CSF leak confirmed by β-2 transferrin test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Polyganics BV Identifier: NCT03566602     History of Changes
Other Study ID Numbers: CIP-1
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebrospinal Fluid Leak
Cerebrospinal Fluid Rhinorrhea
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries