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

March 11, 2015 updated by: Vincent Mutabazi, Ministry of Health, Rwanda

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Rwanda
      • Kigali, Rwanda, 3377
        • Kanombe Military Hospital
        • Contact:
        • Principal Investigator:
          • Jean-Paul Bitega, M.D.
        • Principal Investigator:
          • Leon Muyenzi Ngeruka, M.D.
        • Principal Investigator:
          • Vincent Mutabazi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The semi quantitative count of bacteria on days 0 and 7
Time Frame: Days 0 and 7
Days 0 and 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Placement preparation technique as a measure of reduction of preputial space bacterial load
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Rwanda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

February 15, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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