A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load
NCT ID: NCT02391077
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
33 participants
INTERVENTIONAL
2015-04-30
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue
NCT04484740
Prophylactic Antibiotics or Placebo After Hypospadias Repair
NCT02096159
Oral-only Antibiotics for Bone and Joint Infections in Children
NCT04563325
Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)
NCT02530541
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
NCT06080698
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Arm
Standard PrePex Procedure
No interventions assigned to this group
Arm 1 - Maximal intervention
1. Foreskin disinfection with Povidone-Iodine
2. Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
3. Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days
Povidone-Iodine
Foreskin disinfection with Povidone-Iodine
Antibiotic topical cream
Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Chlorhexidine 1%
Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days
Arm 2 - Medium intervention
1. Foreskin disinfection with Povidone-Iodine
2. Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Povidone-Iodine
Foreskin disinfection with Povidone-Iodine
Antibiotic topical cream
Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Povidone-Iodine
Foreskin disinfection with Povidone-Iodine
Antibiotic topical cream
Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Chlorhexidine 1%
Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
21 Years
49 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Health, Rwanda
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vincent Mutabazi
Director of the Research Grants Unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vincent Mutabazi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Rwanda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kanombe Military Hospital
Kigali, Kigali, Rwanda
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Rwanda Biomedical Centre
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RMC-11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.