Tisseel® versus Hemopatch® for dural sealing in neurosurgery. A prospective study in a tertiary center

Díaz-Molina, Juan Pablo; Martínez, Ricardo Álvarez; González-Vargas, Pedro Miguel; Calero, L.; Azevedo, A. Penna de; Conde, C.

doi:10.1016/j.neuchi.2020.09.008

Cited by 3 publications

(7 citation statements)

References 9 publications

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“…The results from the neurological/spinal cohort of the Hemopatch ® registry show the effectiveness and safety of Hemopatch ® as a hemostatic sealant in neurosurgery. This is in line with previous observations [ 1 , 4 , 10 , 12 - 14 ].…”

Section: Discussionsupporting

confidence: 93%

“…In spinal surgery, CSF leakage rates from 0 to 11.7% have been observed [1,8,9]. In addition to traditional neurosurgical techniques, hemostatic patches such as Hemopatch ® can be helpful tools to achieve watertight closure of the dura mater in order to prevent leakage of CSF into the surrounding tissue [4,10]. Hemopatch ® is composed of a thin, pliable collagen pad coated with a protein-reactive polyethylene glycol monomer (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate, NHS-PEG).…”

Section: Introductionmentioning

confidence: 99%

“…Several small series previously described the effective and reliable use of Hemopatch ® in neurosurgery to reduce the incidence of CSF leakage [1,4,10,[12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

Schebesch¹,

Hrbac²,

Jančálek³

et al. 2023

Cureus

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Background and objectivesCerebrospinal fluid (CSF) leakage is a significant complication in cranial and spinal interventions.Hemostatic patches such as Hemopatch ® are therefore used to support the watertight closure of the dura mater. Recently, we published the results of a large registry documenting the effectiveness and safety of Hemopatch ® in various surgical specialties, including neurosurgery. Here we aimed to analyze the outcomes from the neurological/spinal cohort of this registry in more detail. MethodsBased on the data from the original registry, we performed a post hoc analysis for the neurological/spinal cohort. The Hemopatch ® registry was designed as a prospective, multicenter, single-arm observational study. All surgeons were familiar with the application of Hemopatch ® and it was used at the discretion of the responsible surgeon. The neurological/spinal cohort was open for patients of any age if they had received Hemopatch ® during an open or minimally invasive cranial or spinal procedure. Patients with known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile severe bleeding, or an active infection at the potential target application site (TAS) were excluded from the registry. For the posthoc evaluation, we stratified the patients of the neurological/spinal cohort into two sub-cohorts: cranial and spinal. We collected information about the TAS, intraoperative achievement of watertight closure of the dura, and occurrence of postoperative CSF leaks. ResultsThe registry comprised 148 patients in the neurological/spinal cohort when enrolment was stopped. The dura was the application site for Hemopatch ® in 147 patients (in one patient in the sacral region after tumor excision), of which 123 underwent a cranial procedure. Twenty-four patients underwent a spinal procedure. Intraoperatively, watertight closure was achieved in 130 patients (cranial sub-cohort: 119; spinal subcohort: 11). Postoperative CSF leakage occurred in 11 patients (cranial sub-cohort: nine; spinal sub-cohort: two). We observed no serious adverse events related to Hemopatch ® . ConclusionOur post hoc analysis of real-world data from a European registry confirms the safe and effective use of Hemopatch ® in neurosurgery, including cranial and spinal procedures, as also observed in some case series.

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Section: Discussionsupporting

confidence: 93%

Section: Introductionmentioning

confidence: 99%

“…Several small series previously described the effective and reliable use of Hemopatch ® in neurosurgery to reduce the incidence of CSF leakage [1,4,10,[12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

Schebesch¹,

Hrbac²,

Jančálek³

et al. 2023

Cureus

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“…So far, TISSEEL TM has been effectively utilized for the management of bowel perforations during endoscopic procedures like endoscopic retrograde cholangiopancreatography and esophagogastroduodenoscopy [11,12]. In addition, successful applications of TISSEEL TM have been described in vascular surgery and neurosurgery [13,14].…”

Section: Introductionmentioning

confidence: 99%

The Effect of TISSEELTM on Confined Bowel Perforation: An Experimental Study

et al. 2021

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Objective: During the last decades, surgeons of several specialties presenting different levels of expertise in colon handling have been involved in laparoscopic procedures. The aim of the present experimental study was to investigate the feasibility of TISSEELTM versus the conventional suture placement technique on confined bowel lesions in rats. Methods: Twenty-four Sprague-Dawley rats underwent confined bowel perforation and were divided into three groups: the SUTURE group (sutures were used), the SUTURE + TISSEELTM group (sutures and TISSEELTM were utilized), and the TISSEELTM group (only TISSEELTM was used). Blinded histopathologic analysis followed animal sacrifice. Results: The median weight of the rats was 526 ± 50 g. A single animal had hematochezia on the first postoperative day. Cessation of bleeding at the perforation margin was indicated intraoperatively after TISSEELTM application. Animals in the TISSEELTM group presented less intraperitoneal adhesions and lower hemorrhagic infiltration compared to animals of the two other groups. In addition, animals in the TISSEELTM group showed thrombus formation at the bowel perforation site compared to animals of the two other groups (p = 0.042). Histopathologic analysis demonstrated reduced inflammatory reaction (p = 0.003), diminished fibrosis (p = 0.001), and better tissue regeneration (p = 0.000) in the TISSEELTM group compared to the other two groups. Conclusion: Application of TISSEELTM at the perforation site was associated with increased regeneration of the intestinal wall and less inflammatory and fibrotic reaction compared to suture placement. However, more experimental and clinical studies should be conducted before implementation in humans.

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Hemopatch^®as a primary dural sealant in cranial neurosurgery: Technical note and a retrospective study

Aldahash,

Ansary,

Hallak

et al. 2024

NSJ

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Objectives: To determine the effectiveness and safety of Hemopatch® as a primary dural sealant in preventing CSF leakage following cranial surgery. Cerebrospinal fluid )CSF( leaks occur in cranial operations and are associated with significant patient burden and expense. The use of Hemopatch® as a dural sealant in cranial neurosurgical procedures is described and analyzed in this study.Methods: Data were retrospectively collected from all patients who underwent a craniotomy for various neurosurgical indications where Hemopatch® was used as the primary dural sealant between June 2017 and June 2022. Infection and CSF leak were the main indicators evaluated after surgery.Results: A total of 119 consecutive patients met our inclusion criteria. The median was age 41.5 years, and 52.5% were female. The mean follow-up period was 2.3 years )7 months to 6 years(. There were 110 )92.44%( supratentorial and 9 )7.56%( infratentorial craniotomies. Postoperative CSF leak was reported in 2 patients )1.68%(, one in each cohort. Postoperative infection occurred in one patient )0.84%(. Conclusion:The results suggest that using Hemopatch® as a dural sealant in cranial surgery is effective and safe. After supra-/infratentorial craniotomies, the rate of postoperative adverse events in our sample was within the range of known surgical revision rates. Future randomized clinical studies are required to confirm our encouraging findings.

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Tisseel® versus Hemopatch® for dural sealing in neurosurgery. A prospective study in a tertiary center

Cited by 3 publications

References 9 publications

Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

The Effect of TISSEEL<sup>TM</sup> on Confined Bowel Perforation: An Experimental Study

Hemopatch^®as a primary dural sealant in cranial neurosurgery: Technical note and a retrospective study

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Tisseel® versus Hemopatch® for dural sealing in neurosurgery. A prospective study in a tertiary center

Cited by 3 publications

References 9 publications

Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

The Effect of TISSEEL<sup>TM</sup> on Confined Bowel Perforation: An Experimental Study

Hemopatch®as a primary dural sealant in cranial neurosurgery: Technical note and a retrospective study

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Product

Resources

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Hemopatch^®as a primary dural sealant in cranial neurosurgery: Technical note and a retrospective study