In Vivo and In Vitro Anti-Bacterial Efficacy of Absorbable Barbed Polydioxanone Monofilament Tissue Control Device with Triclosan.

Abstract

This study evaluated the in vitro and in vivo anti-bacterial efficacy of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices in comparison with standard absorbable polydioxanone devices lacking triclosan, utilizing challenges by gram-positive and gram-negative bacteria. The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device was tested for in vitro efficacy against Staphylococcus aureus, methicillin-resistant S. aureus (MRSA), S. epidermidis, methicillin-resistant S. epidermidis (MRSE), Klebsiella pneumoniae, and Escherichia coli using a zone of inhibition (ZOI) assay. The ZOI was used to determine: immediate anti-bacterial efficacy at 24 hours, sustained efficacy for as long as 23 days, and stability for as long as 36 months. Bacterial colonization of the device in vitro was evaluated by scanning electron microscopy and enumerating viable adherent bacteria, expressed as colony-forming units (CFU) per centimeter on the device. In vivo evaluations were conducted in guinea pigs and mice where 3 to 4 cm of the test device and the control suture (commercial Quill™ PDO without triclosan) were implanted subcutaneously through separate catheters into opposite sides of the dorsolateral region. Each implantation site was challenged directly through the indwelling catheter with 106 CFU of S. aureus (guinea pigs) or 107 CFU of E. coli (mice). At 48 hours post-implantation, the test device and control suture were explanted for bacterial enumeration. The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device demonstrated in vitro anti-bacterial activity against all test organisms. This activity was maintained for 11 and 23 days when tested against E. coli and S. aureus, respectively. The device was not colonized by test bacteria in vitro. The anti-bacterial activity remained stable for as long as 36 months of storage at 30°C and 75% relative humidity. In vivo evaluation in animal models demonstrated a 1.16-log reduction in S. aureus and a 1.83-log reduction in E. coli relative to the control device. (p < 0.05) Conclusion: The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device exhibited anti-bacterial efficacy in vitro against a wide range of clinically significant bacterial species with long-lasting inhibition of colonization by S. aureus, and E. coli. It inhibited colonization by S. aureus and E. coli in vitro and in vivo. Thus, the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device represents a powerful technology to help mitigate one of the risk factors for surgical site infections.