A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load

Study Overview
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Brief Summary
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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.

Detailed Description
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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. This trial aims to validate the actions needed to minimize the probability of aerobic and anaerobic bacteria overgrowth once PrePex is introduced, and establish a safer procedure. The trial encompasses different safe and known techniques, such as usage of anti-bacterial topical ointment, its objectives will be evaluated using laboratory tests.

Official Title
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A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal

Conditions
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Disease Due to Gram-positive Bacteria

Intervention / Treatment
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* Other: Povidone-Iodine
* Other: Antibiotic topical cream
* Other: Chlorhexidine 1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Standard PrePex Procedure | |
| Experimental: Arm 1 - Maximal intervention<br>Foreskin disinfection with Povidone-Iodine Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days | Other: Povidone-Iodine<br>* Foreskin disinfection with Povidone-Iodine<br>Other: Antibiotic topical cream<br>* Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus<br>Other: Chlorhexidine 1%<br>* Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days<br>|
| Experimental: Arm 2 - Medium intervention<br>Foreskin disinfection with Povidone-Iodine Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus | Other: Povidone-Iodine<br>* Foreskin disinfection with Povidone-Iodine<br>Other: Antibiotic topical cream<br>* Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The semi quantitative count of bacteria on days 0 and 7 |  | Days 0 and 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placement preparation technique as a measure of reduction of preputial space bacterial load |  | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrePex, Male Circumcision, Bacterial Load