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

Simunye Primary Health Care

Status: Completed

Conditions: Circumcision

Treatments: Procedure: Open surgical circumcision; Device: Unicirc device with tissue adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT01877408

UNICIRC SA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Open surgical circumcision

Active Comparator group

Description:

The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.

Treatment:

Procedure: Open surgical circumcision

Unicirc device with tissue adhesive

Experimental group

Description:

Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.

Treatment:

Device: Unicirc device with tissue adhesive