This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Rapid, Minimally-invasive Voluntary Adult Male Circumcision

This study has been completed.
Information provided by (Responsible Party):
Peter Millard, Simunye Primary Health Care Identifier:
First received: October 11, 2013
Last updated: November 16, 2015
Last verified: November 2015
This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.

Condition Intervention
Circumcision Procedure: Surgical Control Procedure: Unicirc with tissue adhesive

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study

Further study details as provided by Peter Millard, Simunye Primary Health Care:

Primary Outcome Measures:
  • Intraoperative Duration [ Time Frame: 1 hour ]
    The number of minutes required to perform the surgical procedure

Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 1 month ]
    Bleeding, hematoma, infection and other rare adverse events

  • Blood Loss [ Time Frame: During procedure (up to 1 hour) ]
    Number of ml of blood lost during the procedure, as assessed by the surgeon

  • Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks [ Time Frame: 1 month ]
    The number of participants with complete epithelialization (completely healed) at 4 weeks

  • Cosmetic Result [ Time Frame: 6 weeks ]

    Regular: scar line straight without any irregularity

    Irregular: Some irregularity to scar line

    Scalloped: wavy appearane to scar line

Enrollment: 100
Study Start Date: October 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unicirc with tissue adhesive
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Procedure: Unicirc with tissue adhesive
Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
Active Comparator: Surgical control
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Procedure: Surgical Control
The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.

Detailed Description:

Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.

According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."

This quasi-experimental compares the open surgical technique to an alternative minimally-invasive technique using the disposable Unicirc device with tissue adhesive. The controls come from a separate randomized controlled trial (Unicirc 001) that was conducted just prior to the Unicirc 002 case series of 50 subjects. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Healthy men at least 18 years of age requesting circumcision

No anatomical penile abnormalities or infections

Able to provide informed consent to participate

Willing to participate in follow-up visits -

Exclusion Criteria:

Current illness

Penile abnormality or infection which contraindicates or would complicate circumcision

History of bleeding disorder

Past reaction to local anesthetic

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01998360

South Africa
Simunye Primary Healthcare
Mitchells Plain, Western Cape, South Africa
Sponsors and Collaborators
Simunye Primary Health Care
Study Director: Norman Goldstuck, MB ChB Simunye Primary Health Care
  More Information

Responsible Party: Peter Millard, PI, Simunye Primary Health Care Identifier: NCT01998360     History of Changes
Other Study ID Numbers: Unicirc 002
Study First Received: October 11, 2013
Results First Received: November 27, 2013
Last Updated: November 16, 2015

Keywords provided by Peter Millard, Simunye Primary Health Care:
Voluntary medical male circumcision
HIV prevention processed this record on September 19, 2017