Medical Devices: Evidence and Research (Dec 2017)
Preclinical evaluation of the effect of the combined use of the Ethicon Securestrap® Open Absorbable Strap Fixation Device and Ethicon Physiomesh™ Open Flexible Composite Mesh Device on surgeon stress during ventral hernia repair
Abstract
Nadia Sutton,1 Melinda H MacDonald,2 John Lombard,1 Bodgan Ilie,3 Piet Hinoul,4 Douglas A Granger5,6 1Global Health Economics and Market Access, Johnson & Johnson Medical Devices, New Brunswick, NJ, USA; 2Preclinical Center of Excellence, Johnson & Johnson Medical Devices Companies, Somerville, NJ, USA; 3Biostatistics, Ethicon, Somerville, NJ, USA; 4Medical Affairs, Ethicon, Somerville, NJ, USA; 5Institute for Interdisciplinary Salivary Bioscience Research (IISBR), University of California at Irvine, Irvine, CA, USA; 6Johns Hopkins University School of Nursing, Bloomberg School of Public Health, and School of Medicine, Baltimore, MD, USA Aim: To evaluate whether performing ventral hernia repairs using the Ethicon Physiomesh™ Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap® Open Absorbable Strap Fixation Device reduces surgical time and surgeon stress levels, compared with traditional surgical repair methods. Methods: To repair a simulated ventral incisional hernia, two surgeries were performed by eight experienced surgeons using a live porcine model. One procedure involved traditional suture methods and a flat mesh, and the other procedure involved a mechanical fixation device and a skirted flexible composite mesh. A Surgery Task Load Index questionnaire was administered before and after the procedure to establish the surgeons’ perceived stress levels, and saliva samples were collected before, during, and after the surgical procedures to assess the biologically expressed stress (cortisol and salivary alpha amylase) levels. Results: For mechanical fixation using the Ethicon Physiomesh Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap Open Absorbable Strap Fixation Device, surgeons reported a 46.2% reduction in perceived workload stress. There was also a lower physiological reactivity to the intraoperative experience and the total surgical procedure time was reduced by 60.3%. Conclusions: This study provides preliminary findings suggesting that the combined use of a mechanical fixation device and a skirted flexible composite mesh in an open intraperitoneal onlay mesh repair has the potential to reduce surgeon stress. Additional studies are needed to determine whether a reduction in stress is observed in a clinical setting and, if so, confirm that this results in improved clinical outcomes. Keywords: ventral hernia, SURG-TLX, flexible composite mesh device, hernia repair, salivary cortisol, salivary alpha amylase
