NCT01877408

A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Simunye Primary Health Care · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To identify a 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.

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 randomized controlled trial compares the open surgical technique to an alternative minimally-invasive technique using a disposable Unicirc device with tissue adhesive. 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. The study will randomly assign participants to one of two groups: * Unicirc device with tissue adhesive: 100 men * Open surgical circumcision: 50 men The participants will be evaluated during follow-up visits at 2 days, 7 days, 14 days, and 28 days after surgery.

Conditions

• Circumcision

Interventions

Type	Name	Description
PROCEDURE	Open surgical circumcision	Open surgical circumcision using a technique approved by the WHO (dorsal slit)
DEVICE	Unicirc device with tissue adhesive	Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-06-13
• Last updated: 2018-10-02
• Results posted: 2014-02-06

Locations

1 site across 1 country: South Africa