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Trial record 16 of 10356 for:    Anti-Infective Agents AND Bacterial

A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load (RMC-11)

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ClinicalTrials.gov Identifier: NCT02391077
Recruitment Status : Unknown
Verified March 2015 by Vincent Mutabazi, Ministry of Health, Rwanda.
Recruitment status was:  Not yet recruiting
First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Vincent Mutabazi, Ministry of Health, Rwanda

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.

Condition or disease Intervention/treatment Phase
Disease Due to Gram-positive Bacteria Other: Povidone-Iodine Other: Antibiotic topical cream Other: Chlorhexidine 1% Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal
Study Start Date : April 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
No Intervention: Control Arm
Standard PrePex Procedure
Experimental: 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
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

Experimental: 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
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




Primary Outcome Measures :
  1. The semi quantitative count of bacteria on days 0 and 7 [ Time Frame: Days 0 and 7 ]

Secondary Outcome Measures :
  1. Placement preparation technique as a measure of reduction of preputial space bacterial load [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391077


Contacts
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Contact: Vincent Mutabazi, M.D. 250788410827 mutabazivincent@yahoo.com

Locations
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Rwanda
Kanombe Military Hospital Not yet recruiting
Kigali, Rwanda, 3377
Contact: Leon Muyenzi Ngeruka, M.D.    +250 788501063    dr_ngemleon@yahoo.com   
Principal Investigator: Jean-Paul Bitega, M.D.         
Principal Investigator: Leon Muyenzi Ngeruka, M.D.         
Principal Investigator: Vincent Mutabazi, M.D.         
Sponsors and Collaborators
Ministry of Health, Rwanda
Investigators
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Principal Investigator: Vincent Mutabazi, M.D. Ministry of Health, Rwanda

Additional Information:
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Responsible Party: Vincent Mutabazi, Director of the Research Grants Unit, Ministry of Health, Rwanda
ClinicalTrials.gov Identifier: NCT02391077     History of Changes
Other Study ID Numbers: RMC-11
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Vincent Mutabazi, Ministry of Health, Rwanda:
PrePex
Male Circumcision
Bacterial Load

Additional relevant MeSH terms:
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Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local
Dermatologic Agents
Physiological Effects of Drugs
Antibiotics, Antitubercular
Chlorhexidine
Chlorhexidine gluconate
Iodine
Povidone-Iodine
Povidone
Disinfectants
Trace Elements
Micronutrients
Nutrients
Growth Substances
Plasma Substitutes
Blood Substitutes