Reduction in surgical site infections by localized administration with D-PLEX100 in patients with multiple risk factors undergoing colorectal surgery

Abstract

Background: D-PLEX₁₀₀ is a novel drug-eluting lipid polymer matrix that supplies a high, local concentration of doxycycline for approximately 30 days. The objective of this post-hoc analysis was to assess the efficacy of D-PLEX₁₀₀ in preventing superficial and deep SSIs in patients with ≥2 risk factors.

Patients and methods: A post-hoc analysis of a previously reported prospective randomized trial assessing D-PLEX₁₀₀ plus Standard of Care (SOC) versus SOC alone in colorectal surgery was performed to assess SSI rate in patients with ≥2 risk factors.

Results: The overall incidence of SSI was significantly lower for the D-PLEX₁₀₀ arm (9.9%) versus SOC (21%), p = 0.033. Patients with ≥2 risk factors, SSI incidence was 37.5% for SOC and 15.8% in D-PLEX₁₀₀ treated patients.

Conclusions: D-PLEX₁₀₀ reduces the incidence of SSIs beyond benefits associated with SOC treatment alone and including patients with ≥2 risk factors. D-PLEX₁₀₀ may be a promising addition to established SSI prophylaxis bundles.

Keywords: Doxycycline; Localized antibiotic therapy; Risk factors; Surgical site infection.