Unicirc vs Open Surgical Circumcision
Unicirc004
Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial
1 other identifier
interventional
75
1 country
1
Brief Summary
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2015
Shorter than P25 for phase_4
1 active site
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
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
May 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
January 20, 2016
CompletedOctober 3, 2018
September 1, 2018
5 months
April 10, 2015
October 29, 2015
September 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing
Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing
Up to 30 minutes
Secondary Outcomes (4)
Surgical Pain 0=no Pain; 10=Worst Pain Ever
Up to 30 minutes
Completely Healed at 4 Weeks
At the 4-week followup visit
Wound Dehiscence
Up to 4 weeks
Infection
Up to 4 weeks
Study Arms (2)
Unicirc with tissue adhesive
EXPERIMENTALUnicirc under topical anesthetic w/ cyanoacrylate wound sealing
Open Surgical
ACTIVE COMPARATOROpen surgical circumcision under local anesthetic with suturing
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male
- Uncircumcised
- With normal penile anatomy
You may not qualify if:
- Concurrent illness
- History of bleeding disorder
- Past reaction to local anesthetic
- Infection
- Penile abnormality which could complicate circumcision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lonmin Hospital
Marikana, Northwest, South Africa
Related Publications (2)
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.
PMID: 25822727BACKGROUNDShenje 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.
PMID: 27299735DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Justin Shenje
- Organization
- U of Cape Town
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
April 10, 2015
First Posted
May 14, 2015
Study Start
April 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 3, 2018
Results First Posted
January 20, 2016
Record last verified: 2018-09