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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study

Resource links provided by NLM:


Further study details as provided by Simunye Primary Health Care:

Primary Outcome Measures:
  • Intraoperative Duration [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    The number of minutes required to perform the surgical procedure


Secondary Outcome Measures:
  • 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



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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01998360

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

No publications provided

Responsible Party: Peter Millard, PI, Simunye Primary Health Care
ClinicalTrials.gov 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: February 7, 2014
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by Simunye Primary Health Care:
Circumcision
Voluntary medical male circumcision
Minimally-invasive
HIV prevention

ClinicalTrials.gov processed this record on September 22, 2014