Surgical Prophylaxis: Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery (SPADE)

What this Trial Is About

Researchers are evaluating a new approach to reduce Staphylococcus aureus colonization before elective spine surgery. This pilot randomized controlled trial compares a decolonization regimen using polyhexanide with the standard treatment of mupirocin and chlorhexidine. The study aims to assess the feasibility, tolerability, and early effectiveness of these treatments in reducing the bacteria on the skin and in the nose. It also examines changes in the nasal and skin microbiome and tracks the rate of colonization and resistance. Participants are randomly assigned to one of two groups. One group applies Prontoderm4 Nasal Gel and uses Prontoderm4 Foam for a whole-body wash daily for five days before surgery. The other group applies Bactroban4 Nasal ointment and uses Lifo-Scrub4 for whole-body washing on the same schedule. This study includes a treatment period of five days before surgery and monitors participants up to the day of discharge. During the trial, researchers will observe how many participants are successfully randomized and measure adherence, tolerability, side effects, and the burden of treatment. They will collect samples before treatment, immediately after, and at discharge to measure bacterial colonization and resistance rates. The study lasts about two years and gathers information on participant retention and willingness for future trials, ensuring ongoing safety and monitoring throughout the process.

Decolonization Efficacy of Polyhexanide vs. Mupirocin