Rapid, Minimally-invasive Voluntary Adult Male Circumcision
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|ClinicalTrials.gov Identifier: NCT01998360|
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : January 15, 2014
Last Update Posted : December 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Circumcision||Procedure: Surgical Control Procedure: Unicirc with tissue adhesive||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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.
- Intraoperative Duration [ Time Frame: 1 hour ]The number of minutes required to perform the surgical procedure
- Number of Participants With Adverse Events [ Time Frame: 1 month ]Bleeding, hematoma, infection and other rare adverse events
- Blood Loss [ Time Frame: During procedure (up to 1 hour) ]Number of ml of blood lost during the procedure, as assessed by the surgeon
- Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks [ Time Frame: 1 month ]The number of participants with complete epithelialization (completely healed) at 4 weeks
- Cosmetic Result [ Time Frame: 6 weeks ]
Regular: scar line straight without any irregularity
Irregular: Some irregularity to scar line
Scalloped: wavy appearane to scar line
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998360
|Simunye Primary Healthcare|
|Mitchells Plain, Western Cape, South Africa|
|Study Director:||Norman Goldstuck, MB ChB||Simunye Primary Health Care|