Rapid, Minimally-invasive Voluntary Adult Male Circumcision

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

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

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

• Responsible Party: Peter Millard, PI, Simunye Primary Health Care
• ClinicalTrials.gov Identifier: NCT01998360
• Other Study ID Numbers: Unicirc 002
• First Posted: November 28, 2013
• 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:

Circumcision; Voluntary medical male circumcision; Minimally-invasive; HIV prevention