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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 March 2015 |
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Main ID: |
NCT02391077 |
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Date of registration:
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15/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load
RMC-11 |
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Scientific title:
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A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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33 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02391077 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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Rwanda
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Contacts
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Name:
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Vincent Mutabazi, M.D. |
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Address:
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Telephone:
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250788410827 |
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Email:
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mutabazivincent@yahoo.com |
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Affiliation:
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Name:
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Vincent Mutabazi, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ministry of Health, Rwanda |
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Name:
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Leon Muyenzi Ngeruka, M.D. |
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Address:
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Telephone:
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+250 788501063 |
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Email:
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dr_ngemleon@yahoo.com |
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
21 Years
Age maximum:
49 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Disease Due to Gram-positive Bacteria
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Intervention(s)
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Other: Chlorhexidine 1%
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Other: Antibiotic topical cream
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Other: Povidone-Iodine
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Primary Outcome(s)
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The semi quantitative count of bacteria on days 0 and 7
[Time Frame: Days 0 and 7]
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Secondary Outcome(s)
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Placement preparation technique as a measure of reduction of preputial space bacterial load
[Time Frame: Day 0]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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