Rapid, Minimally-invasive Voluntary Adult Male Circumcision

Circumcision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998360
• Other study ID #: Unicirc 002
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2013

Study information

• Verified date: September 2018
• Source: Simunye Primary Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Circumcision

Intervention

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.
• Unicirc with tissue adhesive
Excision of foreskin with Unicirc device and wound sealing with tissue adhesive

Locations

Country	Name	City	State
South Africa	Simunye Primary Healthcare	Mitchells Plain	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
Simunye Primary Health Care

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Duration	The number of minutes required to perform the surgical procedure	1 hour
Secondary	Number of Participants With Adverse Events	Bleeding, hematoma, infection and other rare adverse events	1 month
Secondary	Blood Loss	Number of ml of blood lost during the procedure, as assessed by the surgeon	During procedure (up to 1 hour)
Secondary	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
Secondary	Cosmetic Result	Regular: scar line straight without any irregularity; Irregular: Some irregularity to scar line; Scalloped: wavy appearane to scar line	6 weeks