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

Not Applicable

Completed

Conditions: Circumcision

Interventions: Device: Unicirc device with tissue adhesive
Procedure: Open surgical circumcision

Registration Number: NCT01877408

Lead Sponsor: Simunye Primary Health Care

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 150

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unicirc device with tissue adhesive	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.
Open surgical circumcision	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.

Primary Outcome Measures

Name	Time	Method
Intraoperative Duration	1 hour	Amount of time from first manipulation of tissue under local anesthesia to dressing

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complete Wound Healing by Post-Surgery Week 4	Within 4 weeks after surgery
Pain Experienced	Within 2 days after surgery	Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain
Cosmetic Result	Within 6 weeks after surgery	Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)
Difficulty in Learning and Performing Technique	1 year	Evaluated by doctor survey based on 5 point Likert scale 1. Unicirc is much easier 2. Unicirc is easier 3. Neutral 4. Open surgical is easier 5. Open surgical is much easier
Overall Patient Satisfaction	Within 6 weeks after surgery	Patient satisfaction evaluated with questionnaire using satisfaction scale 1. Very satisfied 2. Satisfied 3. Not satisfied