Unicirc vs Open Surgical Circumcision

Circumcision, Male Clinical Trial

— Unicirc004  

Official title:

Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443792
• Other study ID #: Unicirc004
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2018
• Source: Simunye Primary Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Circumcision, Male

Intervention

Procedure:
• Unicirc with tissue adhesive
As above
• Open Surgical
As above

Locations

Country	Name	City	State
South Africa	Lonmin Hospital	Marikana	Northwest

Sponsors (1)

Lead Sponsor	Collaborator
Simunye Primary Health Care

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical Pain 0=no Pain; 10=Worst Pain Ever	Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever	Up to 30 minutes
Secondary	Completely Healed at 4 Weeks	Number of participants who were completely healed at 4 weeks	At the 4-week followup visit
Secondary	Wound Dehiscence	Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)	Up to 4 weeks
Secondary	Infection	Proportion experiencing post-op infection, determined clinically (treated with antibiotics)	Up to 4 weeks