Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage following Elective Cranial Surgery: The Encase Trial

2021 ◽  
Author(s):  
Tristan P. van Doormaal ◽  
Menno Germans ◽  
Mariska Sie ◽  
Bart Brouwers ◽  
Jorn Fierstra ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Open Label ◽  
Cranial Surgery ◽  
Csf Leakage ◽  
And Performance

scholarly journals Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol

Neurosurgery ◽  
2019 ◽  
Author(s):  
Tristan P C van Doormaal ◽  
Menno R Germans ◽  
Mariska Sie ◽  
Bart Brouwers ◽  
Jorn Fierstra ◽  
...  
Keyword(s):  
Cerebrospinal Fluid ◽  
Primary Endpoint ◽  
Multicenter Study ◽  
Controlled Trial ◽  
Cerebrospinal Fluid Leakage ◽  
Open Label ◽  
Cranial Surgery ◽  
Dural Closure ◽  
Csf Leakage ◽  
And Performance

Abstract BACKGROUND Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery. OBJECTIVE To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. METHODS We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP. EXPECTED OUTCOMES Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy. DISCUSSION As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.

scholarly journals 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 ◽  
Vol 11 (7) ◽  
pp. e049098
Author(s):  
Tristan Van Doormaal ◽  
Menno R Germans ◽  
Mariska Sie ◽  
Bart Brouwers ◽  
Andrew Carlson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Primary Endpoint ◽  
User Satisfaction ◽  
Neurosurgical Procedures ◽  
Open Label ◽  
Cranial Surgery ◽  
Dural Closure ◽  
Handling Characteristics ◽  
Csf Leakage ◽  
And Performance

ObjectiveThe dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.DesignFirst in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up.SettingThree large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland.ParticipantsForty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations.InterventionEach patient received one DSP after cranial surgery and closure of the dura mater with sutures.Outcome measuresPrimary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction.ResultsNo patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean±SD) 3.5 mm±2.0 at day 7 and 2.1 mm±1.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application.ConclusionsDSP, later officially named Liqoseal, is a safe and potentially efficacious device for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage.Trial registration numberNCT03566602.

scholarly journals Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study

2016 ◽  
Vol Volume 9 ◽  
pp. 373-381 ◽  
Author(s):  
Ulrich Kühne ◽  
Jorgen Esmann ◽  
Dennis von Heimburg ◽  
Matthias Imhof ◽  
Petra Weissenberger ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Multicenter Study ◽  
Clinical Setting ◽  
Open Label ◽  
And Performance

scholarly journals Cerebrospinal fluid leakage after cranial surgery in the pediatric population—a systematic review and meta-analysis

2021 ◽  
Author(s):  
Emma M. H. Slot ◽  
Kirsten M. van Baarsen ◽  
Eelco W. Hoving ◽  
Nicolaas P. A. Zuithoff ◽  
Tristan P. C van Doormaal
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Cerebrospinal Fluid ◽  
Pediatric Population ◽  
Meta Analysis ◽  
Leakage Rate ◽  
Csf Leak ◽  
Cerebrospinal Fluid Leakage ◽  
Cranial Surgery ◽  
Csf Leakage

Abstract Background Cerebrospinal fluid (CSF) leakage is a common complication after neurosurgical intervention. It is associated with substantial morbidity and increased healthcare costs. The current systematic review and meta-analysis aim to quantify the incidence of cerebrospinal fluid leakage in the pediatric population and identify its risk factors. Methods The authors followed the PRISMA guidelines. The Embase, PubMed, and Cochrane database were searched for studies reporting CSF leakage after intradural cranial surgery in patients up to 18 years old. Meta-analysis of incidences was performed using a generalized linear mixed model. Results Twenty-six articles were included in this systematic review. Data were retrieved of 2929 patients who underwent a total of 3034 intradural cranial surgeries. Surprisingly, only four of the included articles reported their definition of CSF leakage. The overall CSF leakage rate was 4.4% (95% CI 2.6 to 7.3%). The odds of CSF leakage were significantly greater for craniectomy as opposed to craniotomy (OR 4.7, 95% CI 1.7 to 13.4) and infratentorial as opposed to supratentorial surgery (OR 5.9, 95% CI 1.7 to 20.6). The odds of CSF leakage were significantly lower for duraplasty use versus no duraplasty (OR 0.41 95% CI 0.2 to 0.9). Conclusion The overall CSF leakage rate after intradural cranial surgery in the pediatric population is 4.4%. Risk factors are craniectomy and infratentorial surgery. Duraplasty use is negatively associated with CSF leak. We suggest defining a CSF leak as “leakage of CSF through the skin,” as an unambiguous definition is fundamental for future research.

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