First human use of hybrid synthetic/biologic mesh in ventral hernia repair

a multicenter trial

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

Research output: Contribution to journalArticle

7 Citations (Scopus)

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/m 2 , and classified as VHWG grade 2 (87.3%). Most defects were midline (92.1%) with a mean area of 106 ± 155 cm 2 . 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.

Original languageEnglish (US)
Pages (from-to)1123-1130
Number of pages8
JournalSurgical endoscopy
Volume32
Issue number3
DOIs
StatePublished - Mar 1 2018

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Ventral Hernia
Herniorrhaphy
Biological Products
Multicenter Studies
Wounds and Injuries
Seroma
Surgical Wound Infection
Recurrence
Equipment and Supplies
Incisional Hernia
Hematoma
Body Mass Index
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Bittner, J. G., El-Hayek, K., Strong, A. T., LaPinska, M. P., Yoo, J. S., Pauli, E., & Kroh, M. (2018). First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial. Surgical endoscopy, 32(3), 1123-1130. https://doi.org/10.1007/s00464-017-5715-6
Bittner, James G. ; El-Hayek, Kevin ; Strong, Andrew T. ; LaPinska, Melissa Phillips ; Yoo, Jin S. ; Pauli, Eric ; Kroh, Matthew. / First human use of hybrid synthetic/biologic mesh in ventral hernia repair : a multicenter trial. In: Surgical endoscopy. 2018 ; Vol. 32, No. 3. pp. 1123-1130.
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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 {\circledR} 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/m 2 , and classified as VHWG grade 2 (87.3{\%}). Most defects were midline (92.1{\%}) with a mean area of 106 ± 155 cm 2 . 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 {\circledR} 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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Bittner, JG, El-Hayek, K, Strong, AT, LaPinska, MP, Yoo, JS, Pauli, E & Kroh, M 2018, 'First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial', Surgical endoscopy, vol. 32, no. 3, pp. 1123-1130. https://doi.org/10.1007/s00464-017-5715-6

First human use of hybrid synthetic/biologic mesh in ventral hernia repair : a multicenter trial. / Bittner, James G.; El-Hayek, Kevin; Strong, Andrew T.; LaPinska, Melissa Phillips; Yoo, Jin S.; Pauli, Eric; Kroh, Matthew.

In: Surgical endoscopy, Vol. 32, No. 3, 01.03.2018, p. 1123-1130.

Research output: Contribution to journalArticle

TY - JOUR

T1 - First human use of hybrid synthetic/biologic mesh in ventral hernia repair

T2 - a multicenter trial

AU - Bittner, James G.

AU - El-Hayek, Kevin

AU - Strong, Andrew T.

AU - LaPinska, Melissa Phillips

AU - Yoo, Jin S.

AU - Pauli, Eric

AU - Kroh, Matthew

PY - 2018/3/1

Y1 - 2018/3/1

N2 - 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/m 2 , and classified as VHWG grade 2 (87.3%). Most defects were midline (92.1%) with a mean area of 106 ± 155 cm 2 . 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.

AB - 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/m 2 , and classified as VHWG grade 2 (87.3%). Most defects were midline (92.1%) with a mean area of 106 ± 155 cm 2 . 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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