AvenovaTM as a Sterile Skin Preparation Agent

Early Phase 1CompletedNCT02990013

University of Miami21 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cleaning Product Causing Toxic Effect

Interventions

AvenovaDEVICE

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

Povidone-iodine 5% solutionDRUG

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

4% chlorhexidineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami Bascom Palmer Eye Institute

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Bacterial Identification

Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified.

Time frame: 12 months

Data from ClinicalTrials.gov

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