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

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.

Study Overview

• Status: Completed
• Conditions: Circumcision
• Intervention / Treatment: Procedure: Open surgical circumcision; Device: Unicirc device with tissue adhesive

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• 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 and older (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: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Open surgical circumcision; Open surgical circumcision using a technique approved by the WHO (dorsal slit)
Experimental: 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.	Device: Unicirc device with tissue adhesive; Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Duration	Amount of time from first manipulation of tissue under local anesthesia to dressing	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty in Learning and Performing Technique	Evaluated by doctor survey based on 5 point Likert scale; Unicirc is much easier; Unicirc is easier; Neutral; Open surgical is easier; Open surgical is much easier	1 year
Number of Participants With Complete Wound Healing by Post-Surgery Week 4		Within 4 weeks after surgery
Pain Experienced	Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain	Within 2 days after surgery
Overall Patient Satisfaction	Patient satisfaction evaluated with questionnaire using satisfaction scale; Very satisfied; Satisfied; Not satisfied	Within 6 weeks after surgery
Cosmetic Result	Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)	Within 6 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection	1 year

Collaborators and Investigators

• Sponsor: Simunye Primary Health Care
• Investigators: Principal Investigator: Peter S Millard, MD, PhD, Simunye Primary Health Care

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 13, 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: disposable circumcision device; Tissue adhesive; Open surgical circumcision; Minimally-invasive circumcision
• Other Study ID Numbers: UNICIRC SA