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OpenTrials
Completed

NCT Number: NCT02990013

AvenovaTM as a Sterile Skin Preparation Agent

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

Completed

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Key information

Conditions

Cleaning Product Causing Toxic Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avenova

Device

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

Other names: hypochlorous acid

Povidone-iodine 5% solution

Drug

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

Other names: Betadine

4% Chlorhexidine

Drug

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

Other names: No other names

Isopropyl Alcohol

Drug

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

Other names: No other names

Primary outcomes

  1. Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth

    Time frame: 12 months

    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.

Secondary outcomes

  1. Bacterial Identification

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.