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AvenovaTM as a Sterile Skin Preparation Agent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990013
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Wendy Lee, University of Miami

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Cleaning Product Causing Toxic Effect Device: Avenova Drug: Povidone-iodine 5% solution Drug: 4% chlorhexidine Drug: Isopropyl alcohol Early Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Antimicrobial Activity of AvenovaTM as a Sterile Skin Preparation in Humans
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Treatment arm
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
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 Name: hypochlorous acid

Drug: Povidone-iodine 5% solution
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 Name: Betadine

Drug: 4% chlorhexidine
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 Name: No other names

Drug: Isopropyl alcohol
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 Name: No other names




Primary Outcome Measures :
  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 Outcome Measures :
  1. Bacterial Identification [ Time Frame: 12 months ]
    Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990013


Locations
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United States, Florida
University of Miami Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Wendy Lee Bascom Palmer Eye Institute University of Miami, Miller School of Medicine
Publications:
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Responsible Party: Wendy Lee, Associate Professor of Clinical Ophthalmology & Dermatology, University of Miami
ClinicalTrials.gov Identifier: NCT02990013    
Other Study ID Numbers: 20160881
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Requests can be e-mailed to Dr. Wendy Lee: WLee@med.miami.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Infertility
Chlorhexidine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Plasma Substitutes
Blood Substitutes