Comparison of Antimicrobial Activity of AvenovaTM as a Sterile Skin Preparation in Humans
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 and above able to provide informed consent to participate Adults attending Dr. Wendy Lee Oculoplastics Clinic
排除标准
- •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
研究组 & 干预措施
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
干预措施: Avenova (Device)
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
干预措施: Povidone-iodine 5% solution (Drug)
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
干预措施: 4% chlorhexidine (Drug)
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
干预措施: Isopropyl alcohol (Drug)
结局指标
主要结局
Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth
时间窗: 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.
次要结局
- Bacterial Identification(12 months)
研究者
Wendy Lee
Associate Professor of Clinical Ophthalmology & Dermatology
University of Miami