A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal
试验速览
- 阶段
- 1 期
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- The semi quantitative count of bacteria on days 0 and 7
研究概览
简要总结
There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space, therefore we would like to investigate possible techniques to reduce this potential.
详细描述
The PrePex device was accepted for the World Health Organization (WHO) list of prequalified male circumcision (MC) devices and was listed on 31 May 2013.
PrePex became the first medical device for adult male circumcision to receive WHO prequalification as an alternative to the conventional surgical circumcision methods already recognized by WHO.
Voluntary Medical Male Circumcision (VMMC) is a one-time, low cost intervention that shown to reduce men's risk of HIV infection by approximately 70 percent. The WHO recommends VMMC as part of a comprehensive package of HIV prevention services.
The PrePex compresses the foreskin causing ischemic necrosis. Due to the foreskin necrotic state, it is no longer possible for men to fully retract the skin and properly clean the sulcus and inner foreskin, the sub-preputial space normally has a low oxygen environment facilitating anaerobe growth, and following device placement the environment becomes more so leading to a higher bacterial load. This was suggested by reports of unpleasant odor following device placement and confirmed by laboratory test done by RHSP Uganda of swabs taken from inside the foreskin prior to device removal, results not yet published.
There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space, therefore we would like to investigate possible techniques to reduce this potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages - 21 to 49 years
- •Subject wants to be circumcised
- •Uncircumcised
- •Able to understand the study procedures and requirements
- •Agrees to participate in either arm and to follow the hygiene and wound care instructions
- •Agrees to have swab samples
- •Agrees to abstain sexual intercourse for 6 weeks post device removal
- •Agrees to abstain from masturbation for 2 weeks post device removal
- •Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision
- •Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
- •Subject agrees to anonymous video and photographs of the procedure and follow up visits.
排除标准
- •Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- •Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- •Known bleeding / coagulation abnormality, uncontrolled diabetes, by questionnaire
- •Known allergy to Betadin-Iodine
- •Known allergy to antibiotics containing Bacitracin, Neomycin and Polymixin
- •Subject who have an abnormal penile anatomy or any penile diseases
- •Subject that to the opinion of the investigator is not a good candidate
- •Subject does not agree to anonymous video and photographs of the procedure and follow up visits.
结局指标
主要结局
The semi quantitative count of bacteria on days 0 and 7
时间窗: Days 0 and 7
次要结局
- Placement preparation technique as a measure of reduction of preputial space bacterial load(Day 0)
研究者
Vincent Mutabazi
Director of the Research Grants Unit
Ministry of Health, Rwanda