Unicirc vs Open Surgical Circumcision

NCT ID: NCT02443792

Last Updated: 2018-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.

Detailed Description

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Conditions

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Circumcision, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Unicirc with tissue adhesive

Unicirc under topical anesthetic w/ cyanoacrylate wound sealing

Group Type EXPERIMENTAL

Unicirc with tissue adhesive

Intervention Type PROCEDURE

As above

Open Surgical

Open surgical circumcision under local anesthetic with suturing

Group Type ACTIVE_COMPARATOR

Open Surgical

Intervention Type PROCEDURE

As above

Interventions

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Unicirc with tissue adhesive

As above

Intervention Type PROCEDURE

Open Surgical

As above

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy male
* Uncircumcised
* With normal penile anatomy

Exclusion Criteria

* Concurrent illness
* History of bleeding disorder
* Past reaction to local anesthetic
* Infection
* Penile abnormality which could complicate circumcision
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Simunye Primary Health Care

OTHER

Sponsor Role lead

Responsible Party

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Justin Shenje, MB ChB

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lonmin Hospital

Marikana, Northwest, South Africa

Site Status

Countries

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South Africa

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.

Reference Type BACKGROUND
PMID: 25822727 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27299735 (View on PubMed)

Other Identifiers

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Unicirc004

Identifier Type: -

Identifier Source: org_study_id

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