Omar Elfanagely1, Sammy Othman1, Jonathan A Sanchez2, Arturo Rios-Diaz1, Joseph A Mellia1, John P Fischer3. 1. Division of Plastic Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. 2. Paradigm Surgical LLC, Philadelphia, Pennsylvania. 3. Division of Plastic Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania; Paradigm Surgical LLC, Philadelphia, Pennsylvania. Electronic address: John.Fischer2@pennmedicine.upenn.edu.
Abstract
BACKGROUND: Onlay mesh repair (OMR) has proven to be a widely used, simple, and effective technique for treatment and prevention of hernia occurrence. Despite established benefits, there is still a lack of widespread adoption. In this study, we present the Dual Tacker Device (DTD), an enabling technology that directly addresses the limitations to the adoption of OMR, saving surgical time and effort and making OMR more reproducible across a wide range of patients. METHODS: The DTD mesh fixation system is a semiautomated, hand-held, disposable, multipoint onlay mechanical mesh fixation system that is able to rapidly and uniformly tension and fixate mesh for both hernia treatment and prevention. A cadaveric porcine model was used as a pilot test conducted during a 2 day session to assess the usability of the device and to show that the DTD provided equivalent or superior biomechanical support compared with the standard of care (hand-sewn, OptiFix). RESULTS: Our study included 37 cadaveric porcine incisional closure abdominal wall models. These were divided into four groups: DTD-mediated OMR (n = 14), hand-sewn OMR (n = 7), OptiFix OMR (n = 9), and suture-only repair (no mesh) (n = 7). Eight surgical residents performed device-mediated and hand-sewn OMR. Average time to completion was fastest in the DTD cohort (45.6s) with a statistically significant difference compared with the hand-sewn cohort (343.1s, P < 0.01). No difference in tensile strength was noted between DTD (195.32N), hand-sewn (200.48N), and OptiFix (163.23N). Discreet hand movements were smallest in the DTD (29N) and significant (P < 0.01) when compared with hand-sewn (202N) and OptiFix (35N). CONCLUSIONS: The use of the DTD is not only feasible, but demonstrated improvement in time to completion and economy of movement over current standard of care. While more testing is needed and planned, compared with conventional approaches, the DTD represents a robust proof of principle with promising implications for clinical feasibility and adoptability.
BACKGROUND: Onlay mesh repair (OMR) has proven to be a widely used, simple, and effective technique for treatment and prevention of hernia occurrence. Despite established benefits, there is still a lack of widespread adoption. In this study, we present the Dual Tacker Device (DTD), an enabling technology that directly addresses the limitations to the adoption of OMR, saving surgical time and effort and making OMR more reproducible across a wide range of patients. METHODS: The DTD mesh fixation system is a semiautomated, hand-held, disposable, multipoint onlay mechanical mesh fixation system that is able to rapidly and uniformly tension and fixate mesh for both hernia treatment and prevention. A cadaveric porcine model was used as a pilot test conducted during a 2 day session to assess the usability of the device and to show that the DTD provided equivalent or superior biomechanical support compared with the standard of care (hand-sewn, OptiFix). RESULTS: Our study included 37 cadaveric porcine incisional closure abdominal wall models. These were divided into four groups: DTD-mediated OMR (n = 14), hand-sewn OMR (n = 7), OptiFix OMR (n = 9), and suture-only repair (no mesh) (n = 7). Eight surgical residents performed device-mediated and hand-sewn OMR. Average time to completion was fastest in the DTD cohort (45.6s) with a statistically significant difference compared with the hand-sewn cohort (343.1s, P < 0.01). No difference in tensile strength was noted between DTD (195.32N), hand-sewn (200.48N), and OptiFix (163.23N). Discreet hand movements were smallest in the DTD (29N) and significant (P < 0.01) when compared with hand-sewn (202N) and OptiFix (35N). CONCLUSIONS: The use of the DTD is not only feasible, but demonstrated improvement in time to completion and economy of movement over current standard of care. While more testing is needed and planned, compared with conventional approaches, the DTD represents a robust proof of principle with promising implications for clinical feasibility and adoptability.
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