AvenovaTM as a Sterile Skin Preparation Agent
Primary Purpose
Cleaning Product Causing Toxic Effect
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Avenova
Povidone-iodine 5% solution
4% chlorhexidine
Isopropyl alcohol
Sponsored by
About this trial
This is an interventional basic science trial for Cleaning Product Causing Toxic Effect
Eligibility 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
Sites / Locations
- University of Miami Bascom Palmer Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Bacterial Identification
Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified.
Full Information
NCT ID
NCT02990013
First Posted
November 29, 2016
Last Updated
January 30, 2020
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT02990013
Brief Title
AvenovaTM as a Sterile Skin Preparation Agent
Official Title
Comparison of Antimicrobial Activity of AvenovaTM as a Sterile Skin Preparation in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleaning Product Causing Toxic Effect
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Avenova
Other Intervention Name(s)
hypochlorous acid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Povidone-iodine 5% solution
Other Intervention Name(s)
Betadine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
4% chlorhexidine
Other Intervention Name(s)
No other names
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Isopropyl alcohol
Other Intervention Name(s)
No other names
Intervention Description
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
Primary Outcome Measure Information:
Title
Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth
Description
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 Outcome Measure Information:
Title
Bacterial Identification
Description
Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Lee
Organizational Affiliation
Bascom Palmer Eye Institute University of Miami, Miller School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Requests can be e-mailed to Dr. Wendy Lee: WLee@med.miami.edu
Citations:
PubMed Identifier
25521104
Citation
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.
Results Reference
background
PubMed Identifier
27399954
Citation
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.
Results Reference
background
PubMed Identifier
18677274
Citation
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.
Results Reference
background
PubMed Identifier
17492051
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Learn more about this trial
AvenovaTM as a Sterile Skin Preparation Agent
We'll reach out to this number within 24 hrs