Injections through skin colonized with Staphylococcus aureus biofilm introduce contamination despite standard antimicrobial preparation procedures.
While surgical site preparation has been extensively studied, there is little information about resistance of skin microbiota in the biofilm form to antimicrobial decontamination, and there are no quantitative models to study how biofilm might be transferred into sterile tissue/implant materials during injections for joint spine and tendon, aspiration biopsies and dermal fillers (DF). In this work, we develop two in vitro models to simulate the process of skin preparation and DF injection using pig skin and SimSkin (silicone) materials, respectively. Using the pig skin model, we tested three of the most common skin preparation wipes (alcohol, chlorhexidine and povidone iodine) and found that during wiping they reduced the biofilm bacterial burden of S. aureus (CFU cm-2) by three logs with no statistically significant differences between wipes. Using the SimSkin model, we found that transfer of viable bacteria increased with needle diameter for 30G, 25G and 18G needles. Transfer incidence decreased as injection depth was increased from 1 mm to 3 mm. Serial puncture and linear threading injection styles had similar transfer incidence, whereas fanning significantly increased transfer incidence. The results show that contamination of DF during injection is a risk that can be reduced by modifying skin prep and injection practices.
United States Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Yi
Y
Wang
United States Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Valery
V
Leng
United States Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Viraj
V
Patel
United States Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
K Scott
KS
Phillips
D000818:Animals; D000890:Anti-Infective Agents / Q000494:pharmacology*; D018441:Biofilms; D004195:Disease Models, Animal; D006801:Humans; D013203:Staphylococcal Infections / Q000382:microbiology*; D013207:Staphylococcal Skin Infections / Q000382:microbiology*; D013211:Staphylococcus aureus / Q000187:drug effects* / Q000502:physiology*; D013552:Swine
D000890:Anti-Infective Agents