Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02443792
Other study ID # Unicirc004
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01726036 - Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial N/A
Withdrawn NCT03761836 - Evaluation and Adverse Event Surveillance for Initial Implementation of ShangRing Circumcision in Mozambique N/A
Completed NCT03305523 - The Safety of Thermocautery Usage for Male Children's Circumcisions N/A
Completed NCT03136224 - Examination of Short and Long Term Complications of Thermocautery, Plastic Clamping and Surgical Circumcision Techniques N/A
Enrolling by invitation NCT05764889 - Study on the Protective Effect of a Flexible Sleeve Penis Protection Device on Penis After Circumcision N/A
Completed NCT06120634 - Comparison of Outcomes of Circumcision Via Open and Plastibell Methods N/A
Recruiting NCT02587208 - Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants and Children N/A
Completed NCT02337179 - Male Circumcision Services for HIV Prevention in the Dominican Republic N/A
Completed NCT01300910 - Comparison of the Shang Ring With Conventional Surgical Methods Phase 2/Phase 3
Not yet recruiting NCT02511548 - Increasing Medical Male Circumcision Uptake Phase 3
Completed NCT01186575 - Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision N/A
Completed NCT02593630 - Unicirc Adolescent 12-15 Year Old Boys Phase 4