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

NCT ID: NCT01877408

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-08-31

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.

Conditions

Circumcision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open surgical circumcision

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

Group Type: ACTIVE_COMPARATOR

Open surgical circumcision

Intervention Type: PROCEDURE

Open surgical circumcision using a technique approved by the WHO (dorsal slit)

Unicirc device with tissue adhesive

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.

Group Type: EXPERIMENTAL

Unicirc device with tissue adhesive

Intervention Type: DEVICE

Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.

Interventions

Open surgical circumcision

Open surgical circumcision using a technique approved by the WHO (dorsal slit)

Intervention Type: PROCEDURE

Unicirc device with tissue adhesive

Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Simunye Primary Health Care

OTHER

Sponsor Role: lead

Responsible Party

Peter Millard

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter S Millard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Simunye Primary Health Care

Locations

Simunye Primary Healthcare

Mitchells Plain, Western Cape, South Africa

Countries

South Africa

Other Identifiers

UNICIRC SA

Identifier Type: -

Identifier Source: org_study_id