Biomechanical and Histologic Evaluation of a Novel Absorbable Polydioxanone Mesh in a Porcine Model of Abdominal Wall Repair
Alexei Mlodinow1, Markian Kuzycz, MD, FACS2, Michelle Hasse, MS3, Todd Cruikshank, MBA3, Stephanie Wiegel, MS3, Marco Ellis, MD, FACS1, John Kim, MD, FACS1.
1Northwestern Feinberg School of Medicine Division of Plastic and Reconstructive Surgery, Chicago, IL, USA, 2Aurora Medical Center, Kenosha, WI, USA, 3Surgical Innovation Associates, Chicago, IL, USA.
PURPOSE: Polydioxanone is a well-known bioabsorbable polymer that has been used for 35 years in surgical suture and other implant applications. It is often preferred for wound closure due to its mid-range absorption profile, yet no polydioxanone mesh construct is available for use. This large animal study is the first investigation of a novel macroporous, monofilament, polydioxanone-based surgical mesh (Surgical Innovation Associates, Inc., Chicago IL). It is meant to assess the potential utility of the mesh in abdominal wall reconstruction.
METHODS: 4 full-thickness, 1.5 cm diameter excisional defects were created in the abdominal walls in n=9 Yucatan mini swine through a midline laparotomy approach. Each defect was repaired in a preperitoneal plane with either a test mesh (polydioxanone) or a control mesh (PGA-PMC). In-life clinical pathology was performed, and gross pathology (herniation, mesh migration, hematoma, seroma, necrosis), histopathology, and burst strength of the implant sites was assessed at necropsy at 30-day, 91-day, and 1-year time points.
RESULTS: No adverse events were experienced in-life. No device-related pathology was observed at necropsy or upon histology for either test or control. The polydioxanone mesh was well-integrated and vascularized at both 30- and 90-day time points with minimal/mild Inflammation, fibroplasia, and fibrosis at both time points. The test device demonstrated significantly lower inflammation and inflammatory cell type scores when compared to the control device at 30- and 90-day time points (P=0.021). Burst strength of the test repair sites was higher than that of the adjacent native abdominal wall at all time points (30 days, 91 days, and 1 year), and of the control repair sites.
CONCLUSIONS: The polydioxanone-based mesh and associated neocollagenous tissue in this study provided durable support for a full-thickness abdominal wound in a porcine model, even in the face of declining contribution of the mesh itself. The test device was found to be equivalent or superior to the control device with regards to strength, inflammatory response, tissue ingrowth, and neovascularization.
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