Reduction in surgical site infections by localized administration with D-PLEX₁₀₀ in patients with multiple risk factors undergoing colorectal surgery - 07/03/23

Doi : 10.1016/j.amjsurg.2022.11.021

Anthony J. Senagore ^a,^⁎ , Yafit Stark ^a, Olga Belotserkovsky ^a, Malka Reichert ^a, Nir Wasserberg ^b, Hagit Tulchinsky ^c, Lior Segev ^d, Oded Zmora ^e, Goldi A. Kozloski ^a, Noam Emanuel ^a
^a PolyPid Ltd., Petach Tikvah, Israel
^b Rabin Medical Center, Beilinson Campus, Petach Tikvah, Israel
^c Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel
^d Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel
^e Shamir Medical Center, Be'er Ya'akov, Israel

^∗Corresponding author.

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.

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Highlights

•	SSIs are the most common healthcare-associated infection in the United States.
•	Comorbidities are closely associated with post-operative complications including SSIs.
•	D-PLEX₁₀₀ was developed to address the gap in effective SSI prophylaxis.
•	D-PLEX₁₀₀ provides local antibiotic release with negligible systemic drug levels.
•	D-PLEX₁₀₀ in addition to SOC significantly reduces the incidence of SSIs.