Rapid, Minimally-invasive Voluntary Adult Male Circumcision

Study Overview
=================
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.

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

Conditions
-----------------
Circumcision

Intervention / Treatment
-----------------
* Procedure: Surgical Control
* Procedure: Unicirc with tissue adhesive


Participation Criteria
=================
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 -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circumcision, Voluntary medical male circumcision, Minimally-invasive, HIV prevention