AvenovaTM as a Sterile Skin Preparation Agent



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:December 1, 2019
End Date:January 2020
Contact:Wendy Lee, MD
Email:WLee@med.miami.edu
Phone:305-326-6434

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Comparison of Antimicrobial, Antiviral and Antifungal Activity of AvenovaTM as a Sterile Skin Preparation in Humans

Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome
on human skin

Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
against AvenovaTM as a sterile skin agent

A total of 30 eligible participants will be identified with clinically-acquired information
by Dr. Wendy Lee, an oculoplastic surgeon and aesthetic treatment specialist at Bascom Palmer
Eye Institute, during regular clinic visits.

Part One: Patients will have their skin swabbed and then cultured for various skin flora
agents. The petri dish will then be swabbed with Avenova to see what percent of skin flora
microbe is killed.

Part Two: Patients will have their skin divided into 5 quadrants. The area will be
pre-swabbed to monitor microbe growth. One quadrant will be used as a control. The area will
be cleansed for one minute with AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and
isopropyl alcohol, each in a different quadrant. The area will be post-swabbed for monitor
for microbe growth.

Specific pathogens tested would include staphylococcus epidermides, staphylococcus aureus,
corynebacterium, candida albicans, herpes simplex virus 1 and 2 and adenovirus. Patients will
not be told of positive results as these are normal skin flora.

Inclusion Criteria:

- Adults age 18 and above able to provide informed consent to participate Adults
attending Dr. Wendy Lee Oculoplastics Clinic

Exclusion Criteria:

- Adults unable to consent

- Individuals who less than 18 years of age

- Prisoners

- Pregnant women - while these cleansing agents are used on pregnant women as standard
cleansing agents, effects to fetus unknown

- Patients currently using oral or topical antimicrobial agents

- History of skin infection to facial injectable of surgery

- Inability to tolerate cleansing procedure

- Inability to sit comfortably for 15 - 30 minutes
We found this trial at
1
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Miami, Florida
Principal Investigator: Wendy Lee, MD
Phone: 310-567-0086
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Miami, FL
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