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.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1093/neuros/nyz396 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Case Report: First use of dental bisphenol A-glycidyl methacrylate composite without UV light polymerization for repair of iatrogenic CSF leak following a frontal craniotomy plus tumor resection.
Front Surg
January 2025
Department of Surgery and Specialties, Faculty of Medicine and Pharmaceutical Sciences, University of Douala, Douala, Cameroon.
Objective: This study aimed to evaluate the efficacy and safety of bisphenol A-glycidyl methacrylate (bis-GMA) without UV light polymerization for the repair of refractory iatrogenic cerebrospinal fluid (CSF) leaks with large skull base defects.
Background: CSF leakage remains a common complication after neurosurgical interventions with a substantial resultant impact on morbidity and increased healthcare costs. The management of refractory CSF leaks with large skull base defects remains challenging.
Risk Factors for Development of Diabetes Insipidus and Syndrome of Inappropriate Antidiuretic Hormone Secretion after Transsphenoidal Resection of Pituitary Adenoma.
J Neurol Surg B Skull Base
February 2025
Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States.
We aimed to determine the incidence and risk factors for development of diabetes insipidus (DI) and syndrome of inappropriate antidiuretic hormone secretion (SIADH) after transsphenoidal hypophysectomy (TSH) for resection of a pituitary adenoma. This was a retrospective study of 403 adult patients undergoing TSH for pituitary adenoma. Clinical variables, tumor characteristics, and operative factors were collected.
View Article and Find Full Text PDFCongenital scoliosis presenting in teenage years outcomes without hemivertebra excision.
Spine Deform
January 2025
Department of Orthopaedics, Spinal Deformity and Pediatric Orthopaedics, Billie and George Ross Center for Advanced Pediatric Orthopaedics and Minimally Invasive Spinal Surgery, Cohen Children's Medical Center, Northwell Hofstra School of Medicine, 7 Vermont Drive, Lake Success, NY, 11042, USA.
Purpose: In congenital scoliosis, the surgical strategy approach of hemivertebra excision, with or without instrumentation and fusion, is a common approach to correction of scoliosis. However, hemivertebra excisions are technically challenging, with potential complications including spinal cord injury, nerve root injury and cerebrospinal fluid leak. The purpose of this study was to determine whether correction of congenital scoliosis can be achieved using a posterior instrumentation/fusion-only approach without the need for hemivertebra excision.
View Article and Find Full Text PDFTransthyretin variants impact blood-nerve barrier and neuroinflammation in amyloidotic neuropathy.
Brain
January 2025
Department of Neurology, National Taiwan University Hospital, Taipei, 100225, Taiwan.
Hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) is a neurodegenerative disease caused by mutations in the gene encoding transthyretin (TTR). Despite amyloid deposition being pathognomonic for diagnosis, this pathology in nervous tissues cannot fully account for nerve degeneration, implying additional pathophysiology for neurodegeneration, which, however, has not yet been fully elucidated. In this study, neuroinflammation in ATTRv-PN was investigated by examining nerve morphometry, the blood-nerve barrier, and macrophage infiltration in the sural nerves of ATTRv-PN patients and the sciatic nerves of a complementary mouse system, i.
View Article and Find Full Text PDFVolumetric response after closure of a spinal CSF leak in patients with spontaneous intracranial hypotension: a multicompartmental longitudinal study.
J Neurointerv Surg
January 2025
Department of Neuroradiology, Medical Center - University of Freiburg, Freiburg, Germany
Background: Cerebrospinal fluid (CSF) loss in spontaneous intracranial hypotension (SIH) is accompanied by volume shifts between the intracranial compartments. This study investigated tricompartimental and longitudinal volume shifts after closure of a CSF leak.
Methods: Patients with SIH and suitable pre-therapeutic and post-therapeutic imaging for volumetric analysis were identified from our tertiary care center between 2020 and 2023.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!