AvenovaTM as a Sterile Skin Preparation Agent

Study Overview
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Brief Summary
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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

Detailed Description
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A total of approximately 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 4 quadrants. The area will be pre-swabbed to monitor microbe growth. Each of 4 quadrants will be cleansed for one minute with AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol, then swabbed to monitor for microbe growth. The swabs will be placed in thioglycollate broth to monitor for bacterial growth. If growth if observed in the thioglycollate, the samples will be cultured on blood agar plates and the bacterial specie(s) identified.

Official Title
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Comparison of Antimicrobial Activity of AvenovaTM as a Sterile Skin Preparation in Humans

Conditions
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Cleaning Product Causing Toxic Effect

Intervention / Treatment
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* Device: Avenova
* Drug: Povidone-iodine 5% solution
* Drug: 4% chlorhexidine
* Drug: Isopropyl alcohol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>All patients will be in the treatment arm where they will be subject to skin testing with various cleansing agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol | Device: Avenova<br>* Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol<br>* Other names: hypochlorous acid;Drug: Povidone-iodine 5% solution<br>* Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol<br>* Other names: Betadine;Drug: 4% chlorhexidine<br>* Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol<br>* Other names: No other names;Drug: Isopropyl alcohol<br>* Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol<br>* Other names: No other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth | Growth or no growth of bacteria in the thioglycollate broth will be noted for the control and each quadrant after cleansing with the 4 agents listed above. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Identification | Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified. | 12 months |