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

Publication ,  Journal Article
Bittner, JG; El-Hayek, K; Strong, AT; LaPinska, MP; Yoo, JS; Pauli, EM; Kroh, M
Published in: Surg Endosc
March 2018

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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Published In

Surg Endosc

DOI

EISSN

1432-2218

Publication Date

March 2018

Volume

32

Issue

3

Start / End Page

1123 / 1130

Location

Germany

Related Subject Headings

  • Treatment Outcome
  • Surgical Mesh
  • Surgery
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Herniorrhaphy
  • Hernia, Ventral
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Bittner, J. G., El-Hayek, K., Strong, A. T., LaPinska, M. P., Yoo, J. S., Pauli, E. M., & Kroh, M. (2018). First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial. Surg Endosc, 32(3), 1123–1130. https://doi.org/10.1007/s00464-017-5715-6
Bittner, James G., Kevin El-Hayek, Andrew T. Strong, Melissa Phillips LaPinska, Jin S. Yoo, Eric M. Pauli, and Matthew Kroh. “First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial.Surg Endosc 32, no. 3 (March 2018): 1123–30. https://doi.org/10.1007/s00464-017-5715-6.
Bittner JG, El-Hayek K, Strong AT, LaPinska MP, Yoo JS, Pauli EM, et al. First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial. Surg Endosc. 2018 Mar;32(3):1123–30.
Bittner, James G., et al. “First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial.Surg Endosc, vol. 32, no. 3, Mar. 2018, pp. 1123–30. Pubmed, doi:10.1007/s00464-017-5715-6.
Bittner JG, El-Hayek K, Strong AT, LaPinska MP, Yoo JS, Pauli EM, Kroh M. First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial. Surg Endosc. 2018 Mar;32(3):1123–1130.
Journal cover image

Published In

Surg Endosc

DOI

EISSN

1432-2218

Publication Date

March 2018

Volume

32

Issue

3

Start / End Page

1123 / 1130

Location

Germany

Related Subject Headings

  • Treatment Outcome
  • Surgical Mesh
  • Surgery
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Herniorrhaphy
  • Hernia, Ventral
  • Female