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Surgical Endoscopy
Published in: Surgical Endoscopy 3/2018

01-03-2018

First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial

Authors: James G. Bittner IV, Kevin El-Hayek, Andrew T. Strong, Melissa Phillips LaPinska, Jin S. Yoo, Eric M. Pauli, Matthew Kroh

Published in: Surgical Endoscopy | Issue 3/2018

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Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.
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Metadata
Title
First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial
Authors
James G. Bittner IV
Kevin El-Hayek
Andrew T. Strong
Melissa Phillips LaPinska
Jin S. Yoo
Eric M. Pauli
Matthew Kroh
Publication date
01-03-2018
Publisher
Springer US
Published in
Surgical Endoscopy / Issue 3/2018
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-017-5715-6

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