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

Not Applicable

Completed

• Conditions: Cerebrospinal Fluid Leak
• Interventions: Device: LIQOSEAL; Device: DuraSeal, Adherus

• Registration Number: NCT04086550
• Lead Sponsor: Polyganics BV

Brief Summary

The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® 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 to show noninferiority compared to a control group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-11
• Study Start: 2021-05-20
• Primary Completion: 2024-02-13
• Study Completion: 2024-02-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

pre-operative

1. Subjects who are able to provide written informed consent prior to participating in the clinical investigation.
2. Subjects who are ≥ 18 years old.
3. Subjects who are able to comply with the follow-up or other study requirements.
4. Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed.
5. Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery.

intra-operative

1. Subjects with surgical wound classification Class I/Clean.
2. Subjects with minimally 5 mm of dural space surrounding dural opening.

Exclusion Criteria

pre-operative

1. Female subjects who are pregnant or breastfeeding.
2. Subjects with an assumed impaired coagulation due to medication or otherwise.
3. Subjects suspected of an infection requiring antibiotics.
4. Subjects with any type of dural diseases in planned dural closure area.
5. Subjects requiring re-opening of planned surgical area within 90 days after surgery.
6. Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®.
7. Subjects who previously received a LIQOSEAL®.
8. Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening.
9. Subjects with a presence of hydrocephalus.
10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g. knee replacement].

intra-operative

1. Subjects in whom elevation of PEEP has a potential detrimental effect.
2. Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
3. Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.
4. Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.
5. Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm.
6. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational arm	LIQOSEAL	Application of LIQOSEAL after closure of dura mater
Control arm	DuraSeal, Adherus	Application of Adherus or DurSeal after closure of dura mater

Primary Outcome Measures

Name	Time	Method
Composite endpoint defined as successful dural repair without any of the following compared to the control group: intra-operative CSF leakage percutaneous CSF leak significant pseudomeningocele wound infection	30 days

Trial Locations

Locations (17)

Stanford University; 🇺🇸 Palo Alto, California, United States

Baptist Health; 🇺🇸 Jacksonville, Florida, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Mayo Clinic, Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Cincinnatti; 🇺🇸 Cincinnati, Ohio, United States

OHSU; 🇺🇸 Portland, Oregon, United States

University Hospitals of Innsbruck; 🇦🇹 Innsbruck, Austria

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University Hospital Gent; 🇧🇪 Ghent, Belgium

Elisabeth TweeSteden Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Molinette Hospital; 🇮🇹 Torino, Italy

UMCU; 🇳🇱 Utrecht, Netherlands

University Hospital Zurich; 🇨🇭 Zürich, Switzerland

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

UMM; 🇩🇪 Mannheim, Germany