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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Millard, Simunye Primary Health Care
ClinicalTrials.gov Identifier:
NCT01877408
First received: June 11, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Circumcision
Procedure: Open surgical circumcision
Device: Unicirc device with tissue adhesive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision

Resource links provided by NLM:


Further study details as provided by Simunye Primary Health Care:

Primary Outcome Measures:
  • Intraoperative Duration [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Amount of time from first manipulation of tissue under local anesthesia to dressing


Secondary Outcome Measures:
  • Difficulty in Learning and Performing Technique [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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

  • Number of Participants With Complete Wound Healing by Post-Surgery Week 4 [ Time Frame: Within 4 weeks after surgery ] [ Designated as safety issue: Yes ]
  • Pain Experienced [ Time Frame: Within 2 days after surgery ] [ Designated as safety issue: Yes ]
    Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain

  • Overall Patient Satisfaction [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: No ]

    Patient satisfaction evaluated with questionnaire using satisfaction scale

    1. Very satisfied
    2. Satisfied
    3. Not satisfied

  • Cosmetic Result [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: No ]
    Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)


Other Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection


Enrollment: 150
Study Start Date: June 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: Open surgical circumcision
Open surgical circumcision using a technique approved by the WHO (dorsal slit)
Experimental: 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.
Device: Unicirc device with tissue adhesive
Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877408

Locations
South Africa
Simunye Primary Healthcare
Mitchells Plain, Western Cape, South Africa
Sponsors and Collaborators
Simunye Primary Health Care
Investigators
Principal Investigator: Peter S Millard, MD, PhD Simunye Primary Health Care
  More Information

No publications provided

Responsible Party: Peter Millard, PI, Simunye Primary Health Care
ClinicalTrials.gov Identifier: NCT01877408     History of Changes
Other Study ID Numbers: UNICIRC SA
Study First Received: June 11, 2013
Results First Received: October 29, 2013
Last Updated: January 7, 2014
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by Simunye Primary Health Care:
disposable circumcision device
Tissue adhesive
Open surgical circumcision
Minimally-invasive circumcision

ClinicalTrials.gov processed this record on August 26, 2014