Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
NCT ID: NCT04086550
Last Updated: 2024-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
228 participants
INTERVENTIONAL
2021-05-20
2024-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Investigational arm
Application of LIQOSEAL after closure of dura mater
LIQOSEAL
Adjunctive bioresorbable patch
Control arm
Application of Adherus or DurSeal after closure of dura mater
DuraSeal, Adherus
synthetic absorbable sealants
Interventions
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LIQOSEAL
Adjunctive bioresorbable patch
DuraSeal, Adherus
synthetic absorbable sealants
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Polyganics BV
INDUSTRY
Responsible Party
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Locations
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Stanford University
Palo Alto, California, United States
Baptist Health
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
University of New Mexico
Albuquerque, New Mexico, United States
Lenox Hill Hospital
New York, New York, United States
University of Cincinnatti
Cincinnati, Ohio, United States
OHSU
Portland, Oregon, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University Hospitals of Innsbruck
Innsbruck, , Austria
University Hospital Gent
Ghent, , Belgium
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
UMM
Mannheim, , Germany
Molinette Hospital
Torino, , Italy
Elisabeth TweeSteden Ziekenhuis
Tilburg, , Netherlands
UMCU
Utrecht, , Netherlands
University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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Carlson AP, Slot EMH, van Doormaal TPC; ENCASE II study group; Voormolen EHJ, Dankbaar JW, Depauw P, Brouwers B, Germans MR, Baert E, Vandersteene J, Freyschlag CF, Freyschlag J, Thome C, Zenga F, Penner F, Abdulazim A, Sabel M, Rapp M, Beez T, Zuccarello M, Sauvageau E, Abdullah K, Welch B, Langer D, Ellis J, Dehdashti A, VanGompel J, Bendok B, Chaichana K, Liu J, Dogan A, Lim MK, Hayden MG. Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial. Trials. 2022 Jul 20;23(1):581. doi: 10.1186/s13063-022-06490-8.
Other Identifiers
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CIP-2
Identifier Type: -
Identifier Source: org_study_id
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