A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load (RMC-11)
Primary Purpose
Disease Due to Gram-positive Bacteria
Status
Unknown status
Phase
Phase 1
Locations
Rwanda
Study Type
Interventional
Intervention
Povidone-Iodine
Antibiotic topical cream
Chlorhexidine 1%
Sponsored by
About this trial
This is an interventional prevention trial for Disease Due to Gram-positive Bacteria focused on measuring PrePex, Male Circumcision, Bacterial Load
Eligibility Criteria
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.
Sites / Locations
- Kanombe Military Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Arm
Arm 1 - Maximal intervention
Arm 2 - Medium intervention
Arm Description
Standard PrePex Procedure
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
Foreskin disinfection with Povidone-Iodine Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Outcomes
Primary Outcome Measures
The semi quantitative count of bacteria on days 0 and 7
Secondary Outcome Measures
Placement preparation technique as a measure of reduction of preputial space bacterial load
Full Information
NCT ID
NCT02391077
First Posted
February 15, 2015
Last Updated
March 11, 2015
Sponsor
Ministry of Health, Rwanda
1. Study Identification
Unique Protocol Identification Number
NCT02391077
Brief Title
A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load
Acronym
RMC-11
Official Title
A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Rwanda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease Due to Gram-positive Bacteria
Keywords
PrePex, Male Circumcision, Bacterial Load
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard PrePex Procedure
Arm Title
Arm 1 - Maximal intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 2 - Medium intervention
Arm Type
Experimental
Arm Description
Foreskin disinfection with Povidone-Iodine
Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Intervention Type
Other
Intervention Name(s)
Povidone-Iodine
Intervention Description
Foreskin disinfection with Povidone-Iodine
Intervention Type
Other
Intervention Name(s)
Antibiotic topical cream
Intervention Description
Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Intervention Type
Other
Intervention Name(s)
Chlorhexidine 1%
Intervention Description
Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days
Primary Outcome Measure Information:
Title
The semi quantitative count of bacteria on days 0 and 7
Time Frame
Days 0 and 7
Secondary Outcome Measure Information:
Title
Placement preparation technique as a measure of reduction of preputial space bacterial load
Time Frame
Day 0
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Mutabazi, M.D.
Phone
250788410827
Email
mutabazivincent@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Mutabazi, M.D.
Organizational Affiliation
Ministry of Health, Rwanda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanombe Military Hospital
City
Kigali
ZIP/Postal Code
3377
Country
Rwanda
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Muyenzi Ngeruka, M.D.
Phone
+250 788501063
Email
dr_ngemleon@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jean-Paul Bitega, M.D.
First Name & Middle Initial & Last Name & Degree
Leon Muyenzi Ngeruka, M.D.
First Name & Middle Initial & Last Name & Degree
Vincent Mutabazi, M.D.
12. IPD Sharing Statement
Links:
URL
http://www.rbc.gov.rw/
Description
Rwanda Biomedical Centre
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A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load
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