title: Efficacy and safety of non-suture dural closure using a novel dural substitute consisting of polyglycolic acid felt and fibrin glue to prevent cerebrospinal fluid leakage-A non-controlled, open-label, multicenter clinical trial.
abstract: The objective of this study is to evaluate the efficacy and safety of non-suture dural closure using a novel dural substitute (GM111) consisting of polyglycolic acid felt with a fibrin-glue-coated area commensurate in size with the dural defect. This was a non-controlled, open-label, multicenter clinical trial. The efficacy evaluation endpoints were (1) GM111's intra-operative capability to close dural defects and (2) prevention of cerebrospinal fluid (CSF) leakage and subcutaneous CSF retention throughout the postoperative period (evaluated by diagnostic imaging). Patients meeting the following three preoperative and two intra-operative selection criteria were enrolled: (1) between 12 and <75 years of age; (2) the dura is surmised to be defective and in need of reconstruction; (3) informed written consent was obtained from the patient; (4) the surgical wound is class 1; and (5) the size of duraplasty is ≥0.2 cm2to <100 cm2. Sixty patients were enrolled. The craniotomy site was supratentorial in 77.2%, infratentorial in 12.3% and sellar in 10.5%. The GM111 prosthesis size ranged from 0.24 to 42 cm2. To evaluate the efficacy, intra-operative closure was confirmed by Valsalva's maneuver, water infusion, etc., in all patients. CSF leakage and subcutaneous CSF retention throughout the postoperative period were found in four patients. Adverse events for which a causal relationship with GM111 could not be ruled out occurred in 8.8% of the patients. There were no instances of postoperative infection due to GM111. GM111 showed good closure capability and safety when used for non-suture dural closure.
authors.affiliation: Department of Neurosurgery, Graduate School of Medicine, Hokkaido University, Sapporo, Japan. terasas@med.hokudai.ac.jp.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Terasaka
authors.affiliation: Department of Radiology, School of Medicine, Nagoya University, Nagoya, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Taoka
authors.affiliation: Department of Neurosurgery, Graduate School of Medicine and Pharmaceutical Science, University of Toyama, Toyama, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kuroda
authors.affiliation: Department of Neurosurgery, Sapporo Medical University, Sapporo, Japan.
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Mikuni
authors.affiliation: Department of Neurosurgery, Saiseikai Kumamoto Hospital, Kumamoto, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Nishi
authors.affiliation: Department of Neurosurgery, Nara Medical University, Nara, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nakase
authors.affiliation: Department of Neurosurgery, Brain Research Institute, Niigata University, Niigata, Japan.
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Fujii
authors.affiliation: Department of Neurosurgery, Kanazawa University, Kanazawa, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Hayashi
authors.affiliation: Sapporo Azabu Neurosurgical Hospital, Sapporo, Japan.
authors.forename: Jun-Ichi
authors.initials: JI
authors.lastname: Murata
authors.affiliation: Department of Neurosurgery, University of Fukui, Faculty of Medical Sciences, Fukui, Japan.
authors.forename: Ken-Ichiro
authors.initials: KI
authors.lastname: Kikuta
authors.affiliation: Department of Neurosurgery, Osaka Medical College, Osaka, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Kuroiwa
authors.affiliation: Medical Division, Gunze Limited, Tokyo, Japan.
authors.forename: Sachie
authors.initials: S
authors.lastname: Shimokawa
authors.affiliation: Department of Neurosurgery, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
authors.forename: Kiyohiro
authors.initials: K
authors.lastname: Houkin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D065634:Cerebrospinal Fluid Leak / Q000517:prevention & control*; D004388:Dura Mater / Q000601:surgery*; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011100:Polyglycolic Acid; D011183:Postoperative Complications / Q000517:prevention & control*; D013526:Surgical Mesh; D014014:Tissue Adhesives / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D015718:Fibrin Tissue Adhesive; D014014:Tissue Adhesives; D011100:Polyglycolic Acid