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

Rooijen, M. M. J. van; Jairam, An P.; Tollens, Tim; Jørgensen, Lars Nannestad; Reilingh, T. S. de Vries; Piessen, Guillaume; Köckerling, F.; Miserez, Marc; Windsor, Alastair; Berrevoet, Frederik; Fortelny, René H.; Dousset, B.; Woeste, Guido; Westreenen, Henderik L. van; Gossetti, Francesco; Lange, Johan F.; Tetteroo, G. W. M.; Koch, Andreas; Kroese, Leonard F.; Jeekel, J.

doi:10.1186/s12893-018-0439-7

Cited by 17 publications

(13 citation statements)

References 37 publications

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“…The ATLAS trial (NCT02712398) is a prospective multicentre observational study assessing the use of Phasix™ in at-risk patients (one or more co-morbidities) having a laparoscopic ventral or incisional hernia repair, aiming to recruit 120 participants [ 32 ]. Two further multicentre observational studies (NCT01961687 [ 33 ] and NCT02720042 [ 34 ]) are assessing the role of Phasix™ for ventral or incisional hernia repair. The PREBIOUS trial (NCT02208557) is a multicentre randomised controlled trial of prophylaxis in midline laparotomy closure with a bioabsorbable mesh versus suture closure only and is also currently recruiting [ 35 ].…”

Section: Discussionmentioning

confidence: 99%

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation

Kamarajah

Smart

Daniels

et al. 2020

Hernia

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Background Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterise the stage of innovation for bioabsorbable mesh devices used during both midline closure prophylaxis and complex abdominal wall reconstruction and to evaluate the quality of current evidence. Methods A systematic review of published and ongoing studies was performed until 31st December 2019. Inclusion criteria were studies where bioabsorbable mesh was used to support fascial closure either prophylactically after midline laparotomy or for repair of incisional hernia with midline incision. Exclusion criteria were: (1) study design was a systematic review, meta-analysis, letter, review, comment, or conference abstract; (2) included less than p patients; (3) only evaluated biological, synthetic or composite meshes. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the risk of bias in non-randomised studies of interventions (ROBINS-I) criteria for study quality. Results Twelve studies including 1287 patients were included. Three studies considered mesh prophylaxis and nine studies considered hernia repair. There were only two published studies of IDEAL 2B. The remainder was IDEAL 2A studies. The quality of the evidence was categorised as having a risk of bias of a moderate, serious or critical level in nine of the twelve included studies using the ROBINS-I tool. Conclusion The evidence base for bioabsorbable mesh is limited. Better reporting and quality control of surgical techniques are needed. Although new trial results over the next decade will improve the evidence base, more trials in emergency and contaminated settings are required to establish the limits of indication.

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Section: Discussionmentioning

confidence: 99%

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation

Kamarajah

Smart

Daniels

et al. 2020

Hernia

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“…Phasix ™ mesh is a device made of P4HB [180]. It could become a treatment option for hernia because it has long-term mechanical strength and can prevent further postoperative complications [181,182].…”

Section: Brief Review Of Pha Biomedical Applicationsmentioning

confidence: 99%

Polyhydroxyalkanoates (PHAs) as Biomaterials in Tissue Engineering: Production, Isolation, Characterization

2022

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Polyhydroxyalkanoates (PHAs) are biodegradable and biocompatible biopolymers. These biomaterials have grown in importance in the fields of tissue engineering and tissue reconstruction for structural applications where tissue morphology is critical, such as bone, cartilage, blood vessels, and skin, among others. Furthermore, they can be used to accelerate the regeneration in combination with drugs, as drug delivery systems, thus reducing microbial infections. When cells are cultured under stress conditions, a wide variety of microorganisms produce them as a store of intracellular energy in the form of homo- and copolymers of [R]—hydroxyalkanoic acids, depending on the carbon source used for microorganism growth. This paper gives an overview of PHAs, their biosynthetic pathways, producing microorganisms, cultivation bioprocess, isolation, purification and characterization to obtain biomaterials with medical applications such as tissue engineering.

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“…[ 15 ]. Phasix™ mesh is a resorbable biosynthetic mesh prepared from P4HB [ 16 ]. Interestingly, it provided long-term mechanical strength during hernia repair surgery [ 17 ].…”

Section: Medical Application Of P4hbmentioning

confidence: 99%

Current Advances towards 4-Hydroxybutyrate Containing Polyhydroxyalkanoates Production for Biomedical Applications

2021

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Polyhydroxyalkanoates (PHA) are polyesters having high promise in biomedical applications. Among different types of PHA, poly-4-hydroxybutyrate (P4HB) is the only polymer that has received FDA approval for medical applications. However, most PHA producing microorganisms lack the ability to synthesize P4HB or PHA comprising 4-hydroxybutyrate (4HB) monomer due to their absence of a 4HB monomer supplying pathway. Thus, most microorganisms require supplementation of 4HB precursors to synthesize 4HB polymers. However, usage of 4HB precursors incurs additional production cost. Therefore, researchers have adopted strategies to reduce the cost, such as utilizing low-cost substrate as well as constructing 4HB monomer supplying pathways in microorganisms. We herein summarize the biomedical applications of P4HB, the natural producers of 4HB polymer, and the various strategies that have been applied in producing 4HB polymers in non-4HB producing microorganisms. It is expected that the readers would gain a vivid idea on the different strategic developments in the field of 4HB polymer production.

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

Cited by 17 publications

References 37 publications

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation

Polyhydroxyalkanoates (PHAs) as Biomaterials in Tissue Engineering: Production, Isolation, Characterization

Current Advances towards 4-Hydroxybutyrate Containing Polyhydroxyalkanoates Production for Biomedical Applications

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