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Rapid, Minimally-invasive Voluntary Adult Male Circumcision

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ClinicalTrials.gov Identifier: NCT01998360
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : January 15, 2014
Last Update Posted : October 2, 2018
Information provided by (Responsible Party):
Peter Millard, Simunye Primary Health Care

Brief Summary:
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 or disease Intervention/treatment Phase
Circumcision Procedure: Surgical Control Procedure: Unicirc with tissue adhesive Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : October 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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.

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

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

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

  3. 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

  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998360

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South Africa
Simunye Primary Healthcare
Mitchells Plain, Western Cape, South Africa
Sponsors and Collaborators
Simunye Primary Health Care
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Study Director: Norman Goldstuck, MB ChB Simunye Primary Health Care
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Responsible Party: Peter Millard, PI, Simunye Primary Health Care
ClinicalTrials.gov Identifier: NCT01998360    
Other Study ID Numbers: Unicirc 002
First Posted: November 28, 2013    Key Record Dates
Results First Posted: January 15, 2014
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by Peter Millard, Simunye Primary Health Care:
Voluntary medical male circumcision
HIV prevention