Rapid, Minimally-invasive Voluntary Adult Male Circumcision

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Millard, Simunye Primary Health Care
ClinicalTrials.gov Identifier:
NCT01998360
First received: October 11, 2013
Last updated: February 7, 2014
Last verified: February 2014

October 11, 2013
February 7, 2014
October 2013
October 2013   (final data collection date for primary outcome measure)
Intraoperative Duration [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
The number of minutes required to perform the surgical procedure
Intraoperative duration [ Time Frame: 1 month ] [ Designated as safety issue: No ]
The number of minutes required to perform the surgical procedure
Complete list of historical versions of study NCT01998360 on ClinicalTrials.gov Archive Site
  • Number of Participants With Adverse Events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Bleeding, hematoma, infection and other rare adverse events
  • Blood Loss [ Time Frame: During procedure (up to 1 hour) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The number of participants with complete epithelialization (completely healed) at 4 weeks
  • Cosmetic Result [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Regular: scar line straight without any irregularity

    Irregular: Some irregularity to scar line

    Scalloped: wavy appearane to scar line

  • Adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Bleeding, hematoma, infection and other rare adverse events
  • Blood loss [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Number of ml of blood lost during the procedure, as assessed by the surgeon
  • Time required for complete healing [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The time until complete epithelialization
  • Patient satisfaction [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Satisfaction with results on a 5-point Likert scale
  • Cosmetic result [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Regular, irregular, or scalloped (wavy)
Not Provided
Not Provided
 
Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Circumcision
  • 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.
  • Procedure: Unicirc with tissue adhesive
    Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
  • Experimental: Unicirc with tissue adhesive
    Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
    Intervention: Procedure: Unicirc with tissue adhesive
  • Active Comparator: Surgical control
    Surgical circumcision using forceps guided, dorsal slit, or sleeve method
    Intervention: Procedure: Surgical Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2013
October 2013   (final data collection date for primary outcome measure)

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

-

Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01998360
Unicirc 002
No
Peter Millard, Simunye Primary Health Care
Simunye Primary Health Care
Not Provided
Study Director: Norman Goldstuck, MB ChB Simunye Primary Health Care
Simunye Primary Health Care
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP