James G Bittner1, Kevin El-Hayek2,3, Andrew T Strong2, Melissa Phillips LaPinska4, Jin S Yoo5, Eric M Pauli6, Matthew Kroh7,8,9. 1. Department of Surgery, Virginia Commonwealth University School of Medicine, Richmond, VA, USA. 2. Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA. 3. Department of Surgery, Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA. 4. Department of Surgery, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA. 5. Department of Surgery, Duke University School of Medicine, Durham, NC, USA. 6. Department of Surgery, The Pennsylvania State University College of Medicine, Hershey, PA, USA. 7. Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA. Mkroh@ClevelandClinicAbuDhabi.ae. 8. Department of Surgery, Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA. Mkroh@ClevelandClinicAbuDhabi.ae. 9. Digestive Disease Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates. Mkroh@ClevelandClinicAbuDhabi.ae.
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.
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.
Authors: Charles E Butler; Nadja K Burns; Kristin Turza Campbell; Anshu B Mathur; Mona V Jaffari; Carmen N Rios Journal: J Am Coll Surg Date: 2010-07-14 Impact factor: 6.113
Authors: Arnab Majumder; Joshua S Winder; Yuxiang Wen; Eric M Pauli; Igor Belyansky; Yuri W Novitsky Journal: Surgery Date: 2016-07-21 Impact factor: 3.982
Authors: D Harji; C Thomas; S A Antoniou; H Chandraratan; B Griffiths; B T Henniford; L Horgan; F Köckerling; M López-Cano; L Massey; M Miserez; A Montgomery; F Muysoms; B K Poulose; W Reinpold; N Smart Journal: BJS Open Date: 2021-03-05