First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial
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Mesh options for reinforcement of ventral/incisional hernia (VIH) repair include synthetic or biologic materials. While each material has known advantages and disadvantages, little is understood about outcomes when these materials are used in combination. This multicenter study reports on the first human use of a novel synthetic/biologic hybrid mesh (Zenapro® Hybrid Hernia Repair Device) for VIH repair.
This prospective, multicenter post-market clinical trial enrolled consecutive adults who underwent elective VIH repair with hybrid mesh placed in the intraperitoneal or retromuscular/preperitoneal position. Patients were classified as Ventral Hernia Working Group (VHWG) grades 1–3 and had clean or clean-contaminated wounds. Outcomes of ventral and incisional hernia were compared using appropriate parametric tests.
In all, 63 patients underwent VIH repair with hybrid mesh. Most were females (54.0%), had a mean age of 54.8 ± 10.9 years and mean body mass index of 34.5 ± 7.8 kg/m2, and classified as VHWG grade 2 (87.3%). Most defects were midline (92.1%) with a mean area of 106 ± 155 cm2. Cases were commonly classified as clean (92.1%) and were performed laparoscopically (60.3%). Primary fascial closure was achieved in 82.5% with 28.2% requiring component separation. Mesh location was frequently intraperitoneal (69.8%). Overall, 39% of patients available for follow-up at 12 months suffered surgical site events, which were generally more frequent after incisional hernia repair. Of these, seroma (23.7%) was most common, but few (8.5%) required procedural intervention. Other surgical site events that required procedural intervention included hematoma (1.7%), wound dehiscence (1.7%), and surgical site infection (3.4%). Recurrence rate was 6.8% (95% CI 2.2–16.6%) at 12-months postoperatively.
Zenapro® Hybrid Hernia Repair Device is safe and effective in VHWG grade 1–2 patients with clean wounds out to 12 months. Short-term outcomes and recurrence rate are acceptable. This hybrid mesh represents a novel option for reinforcement during VIH repair.
KeywordsVentral/incisional hernia repair Biologic graft Synthetic mesh Hybrid mesh
Funding for this study was provided by Cook Medical, Inc. (Bloomington, IN).
JGB: Data interpretation, acquisition of data, drafting of manuscript, critical review and final approval of manuscript. KE: Study concept and design, acquisition of data, critical review and final approval of manuscript. ATS: Data interpretation, drafting of manuscript, and final approval of manuscript. MP, JSY, EMP: Acquisition of data, critical review and final approval of manuscript. MK: Study concept and design, acquisition of data, critical review and final approval of manuscript.
Compliance with ethical standards
James G. Bittner IV receives honoraria for speaking/teaching and consulting fees from Cook Medical, CR Bard (Davol), and Intuitive Surgical as well as research support from Cook Biotech, CR Bard (Davol), and EnteroMedics. Melissa Phillips LaPinska receives consulting fees from CR Bard (Davol) and Acelity and research support from Cook Biotech. Jin S. Yoo receives honoraria for speaking/teaching and consulting fees from Novadaq, Stryker, Medtronic, and W.L. Gore, consulting fees from Teleflex, and research support from Cook Biotech. Eric M. Pauli receives honoraria for speaking/teaching from Cook Medical, research support from Cook Biotech, CR Bard (Davol), and MicroMatrix, and personal fees from Boston Scientific, Actuated Medical, and WL Gore. Matthew Kroh receives honoraria for speaking/teaching from Cook Medical, research support from Cook Biotech, and consulting fees from Levita Magnetics, Medtronic, and Teleflex. Kevin El-Hayek and Andrew T. Strong has no disclosures
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