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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

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Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/70034

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
Authors: Terasaka, Shunsuke Browse this author →KAKEN DB
Taoka, Toshiaki Browse this author
Kuroda, Satoshi Browse this author →KAKEN DB
Mikuni, Nobutaka Browse this author
Nishi, Toru Browse this author
Nakase, Hiroyuki Browse this author
Fujii, Yukihiko Browse this author
Hayashi, Yasuhiko Browse this author
Murata, Jun-ichi Browse this author
Kikuta, Ken-ichiro Browse this author
Kuroiwa, Toshihiko Browse this author
Shimokawa, Sachie Browse this author
Houkin, Kiyohiro Browse this author →KAKEN DB
Keywords: Cerebrospinal fluid leakage
Dural substitute
Fibrin glue
Non-suture dural closure
Polyglycolic acid felt
Issue Date: May-2017
Publisher: Springer
Journal Title: Journal of Materials Science : Materials in Medicine
Volume: 28
Issue: 5
Start Page: 69
Publisher DOI: 10.1007/s10856-017-5877-8
PMID: 28357687
Abstract: Objective: 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. Methods: 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 cm2 to <100 cm2. Results: 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 cm2 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. Conclusion: GM111 showed good closure capability and safety when used for non-suture dural closure.
Rights: The final publication is available at link.springer.com
Type: article (author version)
URI: http://hdl.handle.net/2115/70034
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 寺坂 俊介

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