Clinical trial NCT01877408: A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Official title: A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision
Keywords: disposable circumcision device
Tissue adhesive
Open surgical circumcision
Minimally-invasive circumcision
Lead sponsor: Simunye Primary Health Care
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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: Difficulty in Learning and Performing Technique
timeFrame: 1 year
measure: Number of Participants With Complete Wound Healing by Post-Surgery Week 4
timeFrame: Within 4 weeks after surgery
measure: Pain Experienced
timeFrame: Within 2 days after surgery
measure: Overall Patient Satisfaction
timeFrame: Within 6 weeks after surgery
measure: Cosmetic Result
timeFrame: Within 6 weeks after surgery
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 1 year
Locations:
city: Mitchells Plain
country: South Africa
facility: Simunye Primary Healthcare
state: Western Cape
Study officials:
affiliation: Simunye Primary Health Care
name: Peter S Millard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: