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

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). We describe an RCT protocol for patients undergoing primary TKA at two large tertiary care centers. Patients will be randomized 1:1 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. 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.