A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair : a research protocol

  • Background: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients. Methods: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery. Conclusion: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients. Trial registration: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042.

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Author:Mathilde van RooijenORCiD, An Jairam, Tim Tollens, Lars Nannestad JørgensenORCiD, Tammo S. de Vries ReilinghORCiD, Guillaume PiessenORCiD, Ferdinand KöckerlingORCiDGND, Marc Miserez, Alastair C. J. WindsorORCiD, Frederik BerrevoetORCiD, René H. FortelnyORCiD, Bertrand DoussetORCiD, Guido WoesteORCiDGND, Henderik Leendert van WestreenenORCiD, Francesco Gossetti, Johan F. LangeORCiD, Geert W. M. Tetteroo, Andreas Koch, Leonard F. Kroese, Johannes Jeekel
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/30458747
Parent Title (English):BMC surgery
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Year of Completion:2018
Year of first Publication:2018
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2018/12/04
Tag:Biosynthetic mesh; Complex hernia; Complications; Incisional hernia; Mesh repair; Midline laparotomy; Surgical site occurrence
Issue:1, Art. 104
Page Number:9
First Page:1
Last Page:9
Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 4.0