Dataset Information

Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model.

ABSTRACT: Background:Hybrid hernia meshes combine biological tissue-derived extracellular matrix with permanent or resorbable synthetic. The objective of this study was to evaluate hybrid meshes (Gore® Synecor, Zenapro™, Ovitex™ 1S Reinforced Bioscaffold Permanent, and Ovitex™ 1S Reinforced Bioscaffold Resorbable) compared to non-hybrid, bioresorbable synthetic mesh (Phasix™ Mesh) in a rabbit bacterial inoculation model. Materials and methods:Subcutaneous pockets were bilaterally created in male, New Zealand White rabbits (n = 25). Circular meshes (3.8 cm diameter) were implanted and inoculated with 1 × 106 colony forming units (CFU) of clinically-isolated methicillin-resistant Staphylococcus aureus (MRSA). A given animal received a single mesh type. Seven days post-inoculation, animals were euthanized and white material and microbial colonization were assessed by abscess scoring and CFU quantification, respectively. Non-parametric Kruskal-Wallis with Dunn's post-hoc tests compared results for different meshes. Results:Phasix™ Mesh and Synecor exhibited significantly lower abscess scores than Zenapro™, Ovitex™ 1S Permanent, and Ovitex™ 1S Resorbable (p < 0.05). All pocket swabs for Zenapro™ and Ovitex™ meshes were positive for MRSA (100%), with 20% of Synecor and 0% Phasix™ Mesh. Microbial colonization was significantly lower for Phasix™ Mesh (0 CFU) relative to Zenapro™ (6.73 × 107 CFU (median)), Ovitex™ 1S Permanent (7.87 × 107 CFU) and Ovitex™ 1S Resorbable (1.45 × 108 CFU), and for Synecor (0 CFU) relative to both Ovitex™ meshes. Phasix™ Mesh was the only device with no detectable abscess or microbial colonization. Conclusion:Phasix™ Mesh demonstrated no detectable abscess or microbial colonization at 7-days post-implantation and inoculation, in contrast with four hybrid meshes, which all demonstrated colonization in a rabbit bacterial inoculation model.

SUBMITTER: Lake SP

PROVIDER: S-EPMC6710816 | biostudies-other | 2019 Oct

REPOSITORIES: biostudies-other

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Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model.

Lake Spencer P SP Stoikes Nathaniel F N NFN Badhwar Amit A Deeken Corey R CR

Annals of medicine and surgery (2012) 20190813

<h4>Background</h4>Hybrid hernia meshes combine biological tissue-derived extracellular matrix with permanent or resorbable synthetic. The objective of this study was to evaluate hybrid meshes (Gore® Synecor, Zenapro™, Ovitex™ 1S Reinforced Bioscaffold Permanent, and Ovitex™ 1S Reinforced Bioscaffold Resorbable) compared to non-hybrid, bioresorbable synthetic mesh (Phasix™ Mesh) in a rabbit bacterial inoculation model.<h4>Materials and methods</h4>Subcutaneous pockets were bilaterally created in ...[more]

PMID: 31467674

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Project description:BACKGROUND:Minimally invasive incisional hernia repair has been established as a safe and efficient surgical option in most centres worldwide. Laparoscopic technique includes the placement of an intraperitoneal onlay mesh with fixation achieved using spiral tacks or sutures. An additional step is the closure of the fascial defect depending upon its size. Key outcomes in the evaluation of ventral abdominal hernia surgery include postoperative pain, the presence of infection, seroma formation and hernia recurrence. TACKoMESH is a randomised controlled trial that will provide important information on the laparoscopic repair of an incisional hernia; 1) with fascial closure, 2) with an IPOM mesh and 3) comparing the use of an articulating mesh-fixation device that deploys absorbable tacks with a straight-arm mesh-fixation device that deploys non-absorbable tacks. METHODS:A prospective, single-centre, double-blinded randomised trial, TACKoMESH, will establish whether the use of absorbable compared to non-absorbable tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Eligible and consenting patients will be randomized to surgery with one of two tack-fixation devices and followed up for a minimum one year. Secondary outcomes to be explored include wound infection, seroma formation, hernia recurrence, length of postoperative hospital stay, reoperation rate, operation time, health related quality of life and time to return to normal daily activity. DISCUSSION:With ongoing debate around the best management of incisional hernia, continued trials that will add substance are both necessary and important. Laparoscopic techniques have become established in reducing hospital stay and rates of infection and report improvement in some patient centered outcomes whilst achieving similarly low rates of recurrence as open surgical techniques. The laparoscopic method with tack fixation has developed a reputation for its tendency to cause post-operative pain. Novel additions to technique, such as intraoperative-sutured closure of a fascial defect, and developments in surgical technology, such as the evolution of composite mesh design and mesh-fixation devices, have brought about new considerations for patient and surgeon. This study will evaluate the efficacy of several new technical considerations in the setting of elective laparoscopic incisional hernia repair. TRIAL REGISTRATION:Name of registry - ClinicalTrials.gov Registration number: NCT03434301 . Retrospectively registered on 15th February 2018.

Project description:BackgroundIt is an undisputable fact that meshes have become standard for repair of abdominal wall hernias. Whereas in the late eighties there were only a couple of different devices available, today we have to choose among some hundreds, with lots of minor and major variations in polymer and structure. As most of the minor variations may not lead to significant change in clinical outcome and may be regarded as less relevant, we should focus on major differences. Eventually, this is used to structure the world of mesh by forming groups of textile devices with distinct biological response. Many experimental and some clinical studies have underlined the outstanding importance of porosity, which fortunately, in contrast to other biomechanical quanlities, is widely unaffected by the anisotropy of meshes.MethodsIn accordance with the major manufacturers of meshes, a classification of meshes was derived from a huge pool of textile data based briefly on the following: (1) large pores, (2) small pores, (3) additional features, (4) no pores, (5) 3D structure and (6) biological origin. At 1,000 explanted meshes the value of this classification was evaluated by group-specific assessment of inflammatory and connective tissue reaction.ResultsApplication of this classification to common products has proved feasable, and each of the six different classes includes devices that in clinical trials failed to show relevant differences in patients' outcome when comparing products within the same group. Furthermore, histological analysis confirmed significant differences in tissue reactions between but not within the different classes.ConclusionsClassifying implants according to a similar response enables grouping patients into comparable cohorts despite implantation of different devices. Furthermore, it enables the examination of the impact of mesh classes for the various indications even from heterogenous data of registries. Finally and not the least, any grouping supports the surgeon to select the best device to meet the individual need and to tailor patients therapy.

Project description:Regulatory science for medical devices aims to develop new tools, standards and approaches to assess the safety, effectiveness, quality and performance of medical devices. In the field of biomaterials, hernia mesh is a class of implants that have been successfully translated to clinical applications. With a focus on hernia mesh and its regulatory science system, this paper collected and reviewed information on hernia mesh products and biomaterials in both Chinese and American markets. The current development of regulatory science for hernia mesh, including its regulations, standards, guidance documents and classification, and the scientific evaluation of its safety and effectiveness was first reported. Then the research prospect of regulatory science for hernia mesh was discussed. New methods for the preclinical animal study and new tools for the evaluation of the safety and effectiveness of hernia mesh, such as computational modeling, big data platform and evidence-based research, were assessed. By taking the regulatory science of hernia mesh as a case study, this review provided a research basis for developing a regulatory science system of implantable medical devices, furthering the systematic evaluation of the safety and effectiveness of medical devices for better regulatory decision-making. This was the first article reviewing the regulatory science of hernia mesh and biomaterial-based implants. It also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time. Graphical abstract Image 1 Highlights • Hernia mesh is a class of biomaterials-based implants that have been successfully translated to clinical applications.• This is the first article reviewing the current status and future perspectives of regulatory science for hernia mesh.• Research on regenerative medicine, computational modeling, big data and evidence-based research could promote the development.• Evidence-based regulatory science and technical review were also proposed and defined for the first time.

Project description:BackgroundIn ventral hernia surgery, mesh implants are used to reduce recurrence. Infection after mesh implantation can be a problem and rates around 6-10% have been reported. Bacterial colonization of mesh implants in patients without clinical signs of infection has not been thoroughly investigated. Molecular techniques have proven effective in demonstrating bacterial diversity in various environments and are able to identify bacteria on a gene-specific level.ObjectiveThe purpose of this study was to detect bacterial biofilm in mesh implants, analyze its bacterial diversity, and look for possible resemblance with bacterial biofilm from the periodontal pocket.MethodsThirty patients referred to our hospital for recurrence after former ventral hernia mesh repair, were examined for periodontitis in advance of new surgical hernia repair. Oral examination included periapical radiographs, periodontal probing, and subgingival plaque collection. A piece of mesh (1×1 cm) from the abdominal wall was harvested during the new surgical hernia repair and analyzed for bacteria by PCR and 16S rRNA gene sequencing. From patients with positive PCR mesh samples, subgingival plaque samples were analyzed with the same techniques.ResultsA great variety of taxa were detected in 20 (66.7%) mesh samples, including typical oral commensals and periodontopathogens, enterics, and skin bacteria. Mesh and periodontal bacteria were further analyzed for similarity in 16S rRNA gene sequences. In 17 sequences, the level of resemblance between mesh and subgingival bacterial colonization was 98-100% suggesting, but not proving, a transfer of oral bacteria to the mesh.ConclusionThe results show great bacterial diversity on mesh implants from the anterior abdominal wall including oral commensals and periodontopathogens. Mesh can be reached by bacteria in several ways including hematogenous spread from an oral site. However, other sites such as gut and skin may also serve as sources for the mesh biofilm.

Dataset Information

Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model.

Publications

Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model.

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