Rapid, Minimally-invasive Voluntary Adult Male Circumcision

Not Applicable

Completed

Conditions: Circumcision

Interventions: Procedure: Unicirc with tissue adhesive
Procedure: Surgical Control

Registration Number: NCT01998360

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unicirc with tissue adhesive	Unicirc with tissue adhesive	Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Surgical control	Surgical Control	Surgical circumcision using forceps guided, dorsal slit, or sleeve method

Primary Outcome Measures

Name	Time	Method
Intraoperative Duration	1 hour	The number of minutes required to perform the surgical procedure

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks	1 month	The number of participants with complete epithelialization (completely healed) at 4 weeks
Cosmetic Result	6 weeks	Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
Number of Participants With Adverse Events	1 month	Bleeding, hematoma, infection and other rare adverse events
Blood Loss	During procedure (up to 1 hour)	Number of ml of blood lost during the procedure, as assessed by the surgeon