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

Circumcision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877408
• Other study ID #: UNICIRC SA
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: August 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

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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

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:
• Open surgical circumcision
Open surgical circumcision using a technique approved by the WHO (dorsal slit)

Device:
• Unicirc device with tissue adhesive
Removal of foreskin with Unicirc disposal 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
Other	Number of Participants With Adverse Events	Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection	1 year
Primary	Intraoperative Duration	Amount of time from first manipulation of tissue under local anesthesia to dressing	1 hour
Secondary	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
Secondary	Number of Participants With Complete Wound Healing by Post-Surgery Week 4		Within 4 weeks after surgery
Secondary	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
Secondary	Overall Patient Satisfaction	Patient satisfaction evaluated with questionnaire using satisfaction scale; Very satisfied; Satisfied; Not satisfied	Within 6 weeks after surgery
Secondary	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