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Completed

NCT Number: NCT01877408

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

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.

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Key information

Conditions

Circumcision

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Simunye Primary Healthcare

Mitchells Plain, Western Cape, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open surgical circumcision

Procedure

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

Unicirc device with tissue adhesive

Device

Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.

Primary outcomes

  1. Intraoperative Duration

    Time frame: 1 hour

    Amount of time from first manipulation of tissue under local anesthesia to dressing

Secondary outcomes

  1. Difficulty in Learning and Performing Technique

    Time frame: 1 year

    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

  2. Number of Participants With Complete Wound Healing by Post-Surgery Week 4

    Time frame: Within 4 weeks after surgery

  3. Pain Experienced

    Time frame: Within 2 days after surgery

    Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain

  4. Overall Patient Satisfaction

    Time frame: Within 6 weeks after surgery

    Patient satisfaction evaluated with questionnaire using satisfaction scale

    • Very satisfied
    • Satisfied
    • Not satisfied

  5. Cosmetic Result

    Time frame: Within 6 weeks after surgery

    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 outcomes

  1. Number of Participants With Adverse Events

    Time frame: 1 year

    Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection

Sponsors and collaborators

Lead sponsor

Simunye Primary Health Care

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2013
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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