Clinical trial NCT01998360: Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Official title: Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision
Keywords: Circumcision
Voluntary medical male circumcision
Minimally-invasive
HIV prevention
Lead sponsor: Simunye Primary Health Care
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

-

Primary outcomes:
measure: Intraoperative Duration
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 1 month
measure: Blood Loss
timeFrame: During procedure (up to 1 hour)
measure: Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks
timeFrame: 1 month
measure: Cosmetic Result
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Mitchells Plain
country: South Africa
facility: Simunye Primary Healthcare
state: Western Cape
Study officials:
affiliation: Simunye Primary Health Care
name: Norman Goldstuck, MB ChB
role: STUDY_DIRECTOR
References: