Disease Due to Gram-positive Bacteria Clinical Trial
Official title:
A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention