What results can be expected one year after complex incisional hernia repair with biosynthetic mesh?

Vauclair, E.; Bert, M.; Facy, Olivier; Cheynel, N.; Rat, Patrick; Ortega‐Deballon, Pablo

doi:10.1016/j.jviscsurg.2020.07.008

Cited by 18 publications

(15 citation statements)

References 31 publications

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“…In conclusion, the 12-month results of this prospective multi-center study reveal good clinical results and patient outcomes obtained with OviTex 1S Permanent RTM, comparable to and in some cases better than those reported for other mesh materials. Specifically, the recurrence rate appears to be in line or lower than reported in studies with similar populations in the literature [30][31][32][33]. In our experience, the addition of the polymer to the biologic mesh does not appear to increase the risk of mesh infection.…”

Section: Discussionsupporting

confidence: 80%

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis

DeNoto

Ceppa

Pacella

et al. 2021

JCM

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Background: Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation. Methods: This is a prospective, single-arm, multi-center study to evaluate the clinical performance of OviTex® 1S Permanent (OviTex) in the repair of primary or recurrent ventral hernias (VH) in consecutive patients (ClinicalTrials.gov/NCT03074474). The rate of surgical site occurrences (SSOs) was evaluated 90 days post-surgery as the primary endpoint. Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. The incidence of other complications and patient-reported outcomes were also recorded. Results: Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76) reached the 12-month follow-up. All patients were at least 18 years of age with a BMI of <40 kg/m2. Hernia defects were <20 × 20 cm, classified as class I–III according to the CDC wound classification system. Of the 76 patients who reached 12-month follow-up, twenty-six (34%) had previous VH repairs and thirteen (17%) had previous surgical infection. Sixty (79%) had factors known to increase the risk of recurrence. Twenty patients (26%) experienced SSOs, with ten (13%) requiring procedural intervention. Two of the 75 patients (2.7%) experienced a recurrence. Conclusions: The low rate of hernia recurrence and SSOs requiring intervention illustrates the potential that reinforced tissue matrices, and OviTex 1S, in particular, have to improve outcomes in VH repairs. Follow-up to 24 months is ongoing.

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Section: Discussionsupporting

confidence: 80%

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis

DeNoto

Ceppa

Pacella

et al. 2021

JCM

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“…Of the 25 publications that met the inclusion criteria, only two were RCTs [ 8 , 26 ]; 17 were observational retrospective studies [ 12 , 14 , 27 – 41 ] and six were observational prospective studies [ 1 , 3 , 6 , 9 , 19 , 42 ]. Thirteen studies compared permanent synthetic to biologic mesh [ 8 , 12 , 26 – 32 , 34 – 36 , 38 ]; one publication compared synthetic to biosynthetic/slowly absorbable mesh [ 40 ]; two compared biosynthetic/slowly absorbable to biologic implant [ 14 , 41 ] and, 9 articles presented outcomes of biosynthetic/slowly absorbable meshes [ 1 , 3 , 6 , 9 , 14 , 19 , 33 , 39 , 42 ] (six for P4HB mesh, two publications referred to PGA: TMC mesh, and one referred to both P4HB and PGA: TMC meshes. Among the studies using synthetic mesh, polypropylene was the most common material [ 8 , 12 , 26 , 27 , 29 , 30 , 32 , 34 , 35 , 38 , 40 ].…”

Section: Resultsmentioning

confidence: 99%

“…Incisional ventral hernia repair is a common surgical practice. The use of mesh reinforcement has become a reference to prevent hernia recurrence [ 1 , 2 ]. However, the variety of devices—with over 150 mesh products on the market—and surgical techniques make it difficult to evaluate prostheses performance [ 3 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

“…Permanent synthetic meshes are made of non-absorbable materials such as polyester, polypropylene, polyvinylidene fluoride, or polytetrafluoroethylene (PTFE). Although longer used, these prostheses are associated with a risk of postoperative infection and subsequent complications in contaminated or clean-contaminated settings [ 1 , 5 – 7 ]. This previous context led to the development of biologic implants, as an alternative to synthetic meshes [ 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

“…Biosynthetic/slowly absorbable meshes have recently been introduced as a potential alternative to biological implants in contaminated abdominal wall reconstruction [ 6 ]. The absorption rates of these meshes may vary according to their composition: 6 months for polyglycolic acid (PGA): trimethylene carbonate materials (TMC), 12–18 months for poly-4-hydroxybutyrate (P4HB) component, and 12–36 months for a mixture of copolymer fibers of polyglycolide, polylactide, and polytrimethylene carbonate and fibers of polylactide and polytrimethylene carbonate, respectively, in comparison to classical glycolide and lactide mesh, which resorbs in less than two months [ 1 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

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Ventral hernia repair in high-risk patients and contaminated fields using a single mesh: proportional meta-analysis

Morales-Conde

Hernández-Granados

Tallón-Aguilar

et al. 2022

Hernia

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Purpose The use of mesh is a common practice in ventral hernia repair (VHR). Lack of consensus on which prosthetic material works better in different settings remains. This meta-analysis aims to summarize the available evidence on hernia recurrence and complications after repair with synthetic, biologic, or biosynthetic/bioabsorbable meshes in hernias grade 2–3 of the Ventral Hernia Working Group modified classification. Methods A literature search was conducted in January 2021 using Web of Science (WoS), Scopus, and MEDLINE (via PubMed) databases. Randomized Controlled Trials (RCTs) and observational studies with adult patients undergoing VHR with either synthetic, biologic, or biosynthetic/bioabsorbable mesh were included. Outcomes were hernia recurrence, Surgical Site Occurrence (SSO), Surgical Site Infection (SSI), 30 days re-intervention, and infected mesh removal. Random-effects meta-analyses of pooled proportions were performed. Quality of the studies was assessed, and heterogeneity was explored through sensitivity analyses. Results 25 articles were eligible for inclusion. Mean age ranged from 47 to 64 years and participants’ follow-up ranged from 1 to 36 months. Biosynthetic/bioabsorbable mesh reported a 9% (95% CI 2–19%) rate of hernia recurrence, lower than synthetic and biologic meshes. Biosynthetic/bioabsorbable mesh repair also showed a lower incidence of SSI, with a 14% (95% CI 6–24%) rate, and there was no evidence of infected mesh removal. Rates of seroma were similar for the different materials. Conclusions This meta-analysis did not show meaningful differences among materials. However, the best proportions towards lower recurrence and complication rates after grade 2–3 VHR were after using biosynthetic/slowly absorbable mesh reinforcement. These results should be taken with caution, as head-to-head comparative studies between biosynthetic and synthetic/biologic meshes are lacking. Although, biosynthetic/bioabsorbable materials could be considered an alternative to synthetic and biologic mesh reinforcement in these settings. Supplementary Information The online version contains supplementary material available at 10.1007/s10029-022-02668-w.

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Double‐Layer Asymmetric Porous Mesh with Dynamic Mechanical Support Properties Enables Efficient Single‐Stage Repair of Contaminated Abdominal Wall Defect

Tang,

Miao,

Huang

et al. 2024

Advanced Materials

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Pollution tolerance and long‐term mechanical support are the two critical properties of meshes for contaminated abdominal wall defect repair. However, biological meshes with excellent pollution tolerance fail to provide bio‐adaptive long‐term mechanical support due to their rapid degradation. Here, a novel double‐layer asymmetric porous mesh (SIS/PVA‐EXO) is designed by simple and efficient in situ freeze‐thaw of sticky polyvinyl alcohol (PVA) solution on the loosely porous surface of small intestinal submucosal decellularized matrix (SIS), which can successfully repair the contaminated abdominal wall defect with bio‐adaptive dynamic mechanical support through only single‐stage surgery. The exosome‐loaded degradable loosely porous SIS layer accelerates the tissue healing, while the exosome‐loaded densely porous PVA layer can maintain long‐term mechanical support without any abdominal adhesion. In addition, the tensile strength and fracture strain of the SIS/PVA‐EXO mesh change gradually from 0.37 MPa and 210% to 0.10 MPa and 385% with the degradation of SIS layer. This unique performance can dynamically adapt to the variable mechanical demands during different periods of contaminated abdominal wall reconstruction. As a result, our SIS/PVA‐EXO mesh shows an attractive prospect in the treatment of contaminated abdominal wall defect without recurrence by integrating local immune regulation, tissue remodeling, and dynamic mechanical supporting.This article is protected by copyright. All rights reserved

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What results can be expected one year after complex incisional hernia repair with biosynthetic mesh?

Cited by 18 publications

References 31 publications

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis

Ventral hernia repair in high-risk patients and contaminated fields using a single mesh: proportional meta-analysis

Double‐Layer Asymmetric Porous Mesh with Dynamic Mechanical Support Properties Enables Efficient Single‐Stage Repair of Contaminated Abdominal Wall Defect

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