Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
21 participants
INTERVENTIONAL
2018-12-01
2019-12-20
Brief Summary
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Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol against AvenovaTM as a sterile skin agent
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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
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
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
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
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
Interventions
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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
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
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Wendy Lee
Associate Professor of Clinical Ophthalmology & Dermatology
Principal Investigators
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Wendy Lee
Role: PRINCIPAL_INVESTIGATOR
Bascom Palmer Eye Institute University of Miami, Miller School of Medicine
Locations
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University of Miami Bascom Palmer Eye Institute
Miami, Florida, United States
Countries
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References
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Collins LK, Knackstedt TJ, Samie FH. Antiseptic use in Mohs and reconstructive surgery: an American College of Mohs Surgery member survey. Dermatol Surg. 2015 Jan;41(1):164-6. doi: 10.1097/DSS.0000000000000202. No abstract available.
Steinsapir KD, Woodward JA. Chlorhexidine Keratitis: Safety of Chlorhexidine as a Facial Antiseptic. Dermatol Surg. 2017 Jan;43(1):1-6. doi: 10.1097/DSS.0000000000000822.
Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34.
Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr 11;6:e6.
Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA.
Other Identifiers
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20160881
Identifier Type: -
Identifier Source: org_study_id
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