Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2015-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Unicirc with tissue adhesive
Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive
As above
Open Surgical
Open surgical circumcision under local anesthetic with suturing
Open Surgical
As above
Interventions
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Unicirc with tissue adhesive
As above
Open Surgical
As above
Eligibility Criteria
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Inclusion Criteria
* Uncircumcised
* With normal penile anatomy
Exclusion Criteria
* History of bleeding disorder
* Past reaction to local anesthetic
* Infection
* Penile abnormality which could complicate circumcision
18 Years
70 Years
MALE
Yes
Sponsors
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Simunye Primary Health Care
OTHER
Responsible Party
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Justin Shenje, MB ChB
PI
Locations
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Lonmin Hospital
Marikana, Northwest, South Africa
Countries
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References
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Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
Shenje J, Millard PS. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument. PLoS One. 2016 Jun 14;11(6):e0157065. doi: 10.1371/journal.pone.0157065. eCollection 2016.
Other Identifiers
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Unicirc004
Identifier Type: -
Identifier Source: org_study_id
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