Rapid, Minimally-invasive Voluntary Adult Male Circumcision

NCT ID: NCT01998360

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-10-31

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.

Conditions

Circumcision

Study Design

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

Study Groups

Unicirc with tissue adhesive

Excision of foreskin with Unicirc device and sealing wound with tissue adhesive

Group Type: EXPERIMENTAL

Unicirc with tissue adhesive

Intervention Type: PROCEDURE

Excision of foreskin with Unicirc device and wound sealing with tissue adhesive

Surgical control

Surgical circumcision using forceps guided, dorsal slit, or sleeve method

Group Type: ACTIVE_COMPARATOR

Surgical Control

Intervention Type: PROCEDURE

The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.

Interventions

Surgical Control

The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.

Intervention Type: PROCEDURE

Unicirc with tissue adhesive

Excision of foreskin with Unicirc device and wound sealing with tissue adhesive

Intervention Type: PROCEDURE

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
• Maximum Eligible Age: 99 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

Norman Goldstuck, MB ChB

Role: STUDY_DIRECTOR

Simunye Primary Health Care

Locations

Simunye Primary Healthcare

Mitchells Plain, Western Cape, South Africa

Countries

South Africa

Other Identifiers

Unicirc 002

Identifier Type: -

Identifier Source: org_study_id