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Randomized Controlled Trial
. 2022 Apr 1;157(4):293-301.
doi: 10.1001/jamasurg.2021.6902.

Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A Randomized Clinical Trial

Michael J Rosen  1 , David M Krpata  1 , Clayton C Petro  1 , Alfredo Carbonell  2 , Jeremy Warren  2 , Benjamin K Poulose  3 , Adele Costanzo  1 , Chao Tu  4 , Jeffrey Blatnik  5 , Ajita S Prabhu  1
Affiliations
Randomized Controlled Trial

Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A Randomized Clinical Trial

Michael J Rosen et al. JAMA Surg. .

Abstract

Importance: Biologic mesh is widely used for reinforcing contaminated ventral hernia repairs; however, it is expensive and has been associated with high rates of long-term hernia recurrence. Synthetic mesh is a lower-cost alternative but its efficacy has not been rigorously studied in individuals with contaminated hernias.

Objective: To determine whether synthetic mesh results in superior reduction in risk of hernia recurrence compared with biologic mesh during the single-stage repair of clean-contaminated and contaminated ventral hernias.

Design, setting, and participants: This multicenter, single-blinded randomized clinical trial was conducted from December 2012 to April 2019 with a follow-up duration of 2 years. The trial was completed at 5 academic medical centers in the US with specialized units for abdominal wall reconstruction. A total of 253 adult patients with clean-contaminated or contaminated ventral hernias were enrolled in this trial. Follow-up was completed in April 2021.

Interventions: Retromuscular synthetic or biologic mesh at the time of fascial closure.

Main outcomes and measures: The primary outcome was the superiority of synthetic mesh vs biologic mesh at reducing risk of hernia recurrence at 2 years based on intent-to-treat analysis. Secondary outcomes included mesh safety, defined as the rate of surgical site occurrence requiring a procedural intervention, and 30-day hospital direct costs and prosthetic costs.

Results: A total of 253 patients (median [IQR] age, 64 [55-70] years; 117 [46%] male) were randomized (126 to synthetic mesh and 127 to biologic mesh) and the follow-up rate was 92% at 2 years. Compared with biologic mesh, synthetic mesh significantly reduced the risk of hernia recurrence (hazard ratio, 0.31; 95% CI, 0.23-0.42; P < .001). The overall intent-to-treat hernia recurrence risk at 2 years was 13% (33 of 253 patients). Recurrence risk with biologic mesh was 20.5% (26 of 127 patients) and with synthetic mesh was 5.6% (7 of 126 patients), with an absolute risk reduction of 14.9% with the use of synthetic mesh (95% CI, -23.8% to -6.1%; P = .001). There was no significant difference in overall 2-year risk of surgical site occurrence requiring a procedural intervention between the groups (odds ratio, 1.22; 95% CI, 0.60-2.44; P = .58). Median (IQR) 30-day hospital direct costs were significantly greater in the biologic group vs the synthetic group ($44 936 [$35 877-$52 656] vs $17 289 [$14 643-$22 901], respectively; P < .001). There was also a significant difference in the price of the prosthetic device between the 2 groups (median [IQR] cost biologic, $21 539 [$20 285-$23 332] vs synthetic, $105 [$105-$118]; P < .001).

Conclusions and relevance: Synthetic mesh demonstrated superior 2-year hernia recurrence risk compared with biologic mesh in patients undergoing single-stage repair of contaminated ventral hernias, and both meshes demonstrated similar safety profiles. The price of biologic mesh was over 200 times that of synthetic mesh for these outcomes.

Trial registration: ClinicalTrials.gov Identifier: NCT02451176.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Rosen reports receiving salary support as medical director of the nonprofit Abdominal Core Health Quality Collaborative and serves as a board member with stock options for Ariste Medical. Dr Carbonell reports honoraria from Intuitive Surgical, W.L. Gore & Associates, and Ethicon Inc. Dr Warren reports serving as a consultant and/or speaker for Ethicon, W.L. Gore & Associates, and CMR surgical, and as a speaker and proctor for Intuitive Surgical. Dr Poulose reports salary support for serving as Director of Quality and Outcomes for the Abdominal Core Health Quality Collaborative and research support from BD Interventional and Advanced Medical Solutions (paid to institution). Dr Blatnik reports serving as a consultant for BD Interventional and Intuitive Surgical as well as research support from Ethicon and Cook Biomedical. Dr Prabhu reports research grants from Intuitive Surgical and serving as a consultant for CMR Surgical and Verb Surgical. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
Figure 2.
Figure 2.. Kaplan-Meier Plot of Time to Hernia Recurrence
See this image and copyright information in PMC

Comment in

References

    1. Poulose BK, Shelton J, Phillips S, et al. . Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012;16(2):179-183. doi:10.1007/s10029-011-0879-9 - DOI - PubMed
    1. Rosen MJ, Krpata DM, Ermlich B, Blatnik JA. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg. 2013;257(6):991-996. doi:10.1097/SLA.0b013e3182849871 - DOI - PubMed
    1. Köckerling F, Alam NN, Antoniou SA, et al. . What is the evidence for the use of biologic or biosynthetic meshes in abdominal wall reconstruction? Hernia. 2018;22(2):249-269. doi:10.1007/s10029-018-1735-y - DOI - PMC - PubMed
    1. Huerta S, Varshney A, Patel PM, Mayo HG, Livingston EH. Biological mesh implants for abdominal hernia repair: US food and drug administration approval process and systematic review of its efficacy. JAMA Surg. 2016;151(4):374-381. doi:10.1001/jamasurg.2015.5234 - DOI - PubMed
    1. United States Securities and Exchange Commission. Tela Bio Annual Report. Published 2020. Accessed March 5, 2021. https://ir.telabio.com/static-files/05ac9577-950e-4607-a4e4-e00cd0851ff7

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