NCT02391077

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Ministry of Health, Rwanda · Other Government
• Sex: Male
• Age: 21 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Disease Due to Gram-positive Bacteria

Interventions

Type	Name	Description
OTHER	Povidone-Iodine	Foreskin disinfection with Povidone-Iodine
OTHER	Antibiotic topical cream	Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
OTHER	Chlorhexidine 1%	Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-03-18
• Last updated: 2015-03-18

Locations

1 site across 1 country: Rwanda