Rapid, Minimally-invasive Voluntary Adult Male Circumcision

Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study

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.

Study Overview

• Status: Completed
• Conditions: Circumcision
• Intervention / Treatment: Procedure: Unicirc with tissue adhesive; Procedure: Surgical Control

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Mitchells Plain, Western Cape, South Africa
      • Simunye Primary Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unicirc with tissue adhesive; Excision of foreskin with Unicirc device and sealing wound with tissue adhesive	Procedure: Unicirc with tissue adhesive; Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
Active Comparator: Surgical control; Surgical circumcision using forceps guided, dorsal slit, or sleeve method	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Duration	The number of minutes required to perform the surgical procedure	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Bleeding, hematoma, infection and other rare adverse events	1 month
Blood Loss	Number of ml of blood lost during the procedure, as assessed by the surgeon	During procedure (up to 1 hour)
Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks	The number of participants with complete epithelialization (completely healed) at 4 weeks	1 month
Cosmetic Result	Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line	6 weeks

Collaborators and Investigators

• Sponsor: Simunye Primary Health Care
• Investigators: Study Director: Norman Goldstuck, MB ChB, Simunye Primary Health Care

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: November 23, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: HIV prevention; Circumcision; Minimally-invasive; Voluntary medical male circumcision
• Other Study ID Numbers: Unicirc 002