AvenovaTM as a Sterile Skin Preparation Agent

University of Miami

Status and phase: Completed; Early Phase 1

Conditions: Cleaning Product Causing Toxic Effect

Treatments: Drug: Isopropyl alcohol; Drug: Povidone-iodine 5% solution; Drug: 4% chlorhexidine; Device: Avenova

Study type: Interventional

Funder types: Other

Identifiers

NCT02990013

20160881

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Treatment arm

Experimental group

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

Treatment:

Device: Avenova

Drug: 4% chlorhexidine

Drug: Povidone-iodine 5% solution

Drug: Isopropyl alcohol