Review of a Novel Antimicrobial Wound Gel System Used in Total Knee Arthroplasty Including a Protocol for a Randomized Controlled Trial at Our Institutions.

ABSTRACT

INTRODUCTION: Surgical-site infections (SSIs) remain a challenging complication following total knee arthroplasty (TKA) with estimates nearing 2%. Current antimicrobial dressing options have gained popularity despite reported bacterial resistance and ineffectiveness. Bacteria can produce an extracellular polymeric substance (EPS), thereby rendering infections difficult to treat. Recently, a novel antimicrobial wound gel system has been developed to address EPS-associated infections. This new technology is comprised of various components that act to break bonds and cross-linking within EPS, induce lysis, and provide a moist environment to promote healing. In this paper, we provide a background of (1) wound infections; (2) biofilms; and (3) current dressing options. We will then describe a novel antimicrobial gel therapy with a summary of a randomized control trial (RCT). MATERIALS AND METHODS: We describe an RCT protocol for patients undergoing primary TKA at two large tertiary care centers. Patients will be randomized 11 using permutated block methodology to either standard of care (SOC) or a novel antimicrobial wound gel system, yielding 750 patients in each treatment arm. Inclusion criteria include patients scheduled to undergo primary TKA. The primary outcome is the appearance of a surgical-site complication. CONCLUSION: We briefly describe the background of wound healing and biofilm, as well as current treatment modalities including antimicrobial dressings and a novel technology developed to address the EPS component of bacteria. In addition, we describe a protocol for a randomized controlled trial examining the effects of this novel therapy on surgical-site complications in patients undergoing primary TKA.