NCT02391077

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

February 15, 2015

Last Update Submit

March 11, 2015

Conditions

Disease Due to Gram-positive Bacteria

Keywords

PrePexMale CircumcisionBacterial Load

Outcome Measures

Primary Outcomes (1)

  • The semi quantitative count of bacteria on days 0 and 7

    Days 0 and 7

Secondary Outcomes (1)

  • Placement preparation technique as a measure of reduction of preputial space bacterial load

    Day 0

Study Arms (3)

Control Arm

NO INTERVENTION

Standard PrePex Procedure

Arm 1 - Maximal intervention

EXPERIMENTAL

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-IodineOther: Antibiotic topical creamOther: Chlorhexidine 1%

Arm 2 - Medium intervention

EXPERIMENTAL

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-IodineOther: Antibiotic topical cream

Interventions

Povidone-IodineOTHER

Foreskin disinfection with Povidone-Iodine

Arm 1 - Maximal interventionArm 2 - Medium intervention
Antibiotic topical creamOTHER

Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus

Arm 1 - Maximal interventionArm 2 - Medium intervention
Chlorhexidine 1%OTHER

Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days

Arm 1 - Maximal intervention

Eligibility Criteria

Age21 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanombe Military Hospital

Kigali, Kigali, 3377, Rwanda

Location

Related Links

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Vincent Mutabazi, M.D.

    Ministry of Health, Rwanda

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Mutabazi, M.D.

CONTACT

250788410827mutabazivincent@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Research Grants Unit

Study Record Dates

First Submitted

February 15, 2015

First Posted

March 18, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

RW(1)