Antimicrobial performance of two preoperative skin preparation solutions containing iodine and isopropyl alcohol

M Hamid Bashir,Angela Hollingsworth,Jennifer D Thompson,Dee Shortridge,Spencer P Lake,Corey R Deeken,Daniel Zimbler,Maleeha Mashiatulla,Lingzhi Li,Maya P Singh,Erin C Zook

doi:10.1016/j.ajic.2021.10.031

Abstract

BackgroundHealthcare-associated infections (HAIs) are a persistent clinical challenge caused primarily by bacteria on the skin. Proper utilization of optimized antiseptic skin preparation solutions helps reduce the prevalence and impact of HAIs by decreasing patient skin microorganisms preoperatively. The purpose of this study was to evaluate the efficacy of 2 antimicrobial solutions containing iodine and isopropyl alcohol (IPA): Povidone iodine (PVP-I) with IPA (ie, PVP-I+IPA, PurPrep) and Iodine Povacrylex+IPA (DuraPrep). MethodsThe antimicrobial activity of the test solutions was evaluated in vitro by determinations of minimum inhibitory concentrations (MICs) and minimum bactericidal concentrations (MBCs) against 1105 diverse microbial isolates and a time-kill assay to evaluate efficacy against 120 strains of Gram-positive and Gram-negative bacteria and yeasts. Peel tests were performed between skin samples treated with test solutions and representative drape/dressing materials to determine effects of test solutions on the biomechanical adhesion properties. Finally, an Institutional Review Board (IRB)-approved, randomized, controlled, single-center, partially blinded in vivo study was performed to assess the immediate and persistent antimicrobial activity of the test solutions on the abdomen and groin. ResultsBoth PVP-I+IPA and Iodine Povacrylex+IPA solutions demonstrated broad-spectrum antimicrobial activity with MIC and MBC at less than 1% of the full-strength concentration of each product against a wide variety of microorganisms. In the time-kill tests, both solutions were able to successfully reduce all microbial populations by 99.99% (ie, 4 log10) at the contact times of 30 seconds, 2 minutes and 10 minutes. The 2 solutions showed relatively similar adhesion results when tested with 3 representative operating room materials. Both PVP-I+IPA and Iodine Povacrylex+IPA met the expected Food and Drug Administration (FDA) efficacy requirements at 10 minutes and 6 hours post-treatment for both anatomic sites (ie, groin, and abdomen) in the clinical study, with no safety issues or adverse events. ConclusionsAnalysis of the in vitro antimicrobial activity, biomechanical adhesive strength, and in vivo efficacy of PVP-I+IPA demonstrated similar results compared to Iodine Povacrylex+IPA. Both products were efficacious at reducing or eliminating a wide range of clinically-relevant microorganisms in lab-based and clinical settings, supporting their use as antiseptic skin preparation solutions to reduce bacteria on the skin that can cause infection.

Highlights

Healthcare-associated infections (HAIs) are a persistent clinical challenge caused primarily by bacteria on the skin
For minimum inhibitory concentrations (MICs) evaluations, Polyvinylpyrrolidone (povidone) iodine (PVP-I)+isopropyl alcohol (IPA) was effective at inhibiting growth of Gram-positive bacteria, Gram-negative bacteria, and yeasts with MIC50 and MIC90 concentration values ranging between 0.06% and 0.5% and 0.12% and 1%, respectively (Fig 1)
Compared to Iodine Povacrylex+IPA, MIC values for PVP-I +IPA were lower for 14 species, identical for 6 species, and higher for only 2 species of microorganisms

Summary

Introduction

Healthcare-associated infections (HAIs) are a persistent clinical challenge caused primarily by bacteria on the skin. To assess the immediate antimicrobial effect, the lower bound 95% CI from the test solutions were compared to the FDA requirement of achieving greater than 2 and 3 log[10] CFU/cm[2] reductions on the abdomen and groin, respectively, 10 minutes after application.

Objectives

Results

Conclusion