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

Abstract

<h4>Importance</h4>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.<h4>Objective</h4>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.<h4>Design, setting, and participants</h4>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.<h4>Interventions</h4>Retromuscular synthetic or biologic mesh at the time of fascial closure.<h4>Main outcomes and measures</h4>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.<h4>Results</h4>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).<h4>Conclusions and relevance</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT02451176.