AvenovaTM as a Sterile Skin Preparation Agent
- Conditions
- Cleaning Product Causing Toxic Effect
- Interventions
- Registration Number
- NCT02990013
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Adults age 18 and above able to provide informed consent to participate Adults attending Dr. Wendy Lee Oculoplastics Clinic
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm Povidone-iodine 5% solution 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 Treatment arm 4% chlorhexidine 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 Treatment arm Avenova 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 Treatment arm Isopropyl alcohol 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
- Primary Outcome Measures
Name Time Method Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth 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
Name Time Method Bacterial Identification 12 months Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified.
Trial Locations
- Locations (1)
University of Miami Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States