CircumcisionNCT01998360
Rapid, Minimally-invasive Voluntary Adult Male Circumcision
A study testing Unicirc with tissue adhesive in people with Circumcision, run by Simunye Primary Health Care at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision
- What is being tested?
- Unicirc with tissue adhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- Current illness
- Penile abnormality or infection which contraindicates or would complicate circumcision
- History of bleeding disorder
- Past reaction to local anesthetic
- -
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Simunye Primary Healthcare
Mitchells Plain, Western Cape
About this study
Official title: Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study
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.
Read the 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 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.
- Conditions
- Circumcision
- Being tested
- Surgical Control, Unicirc with tissue adhesive
- Keywords
- Circumcision, Voluntary medical male circumcision, Minimally-invasive, HIV prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ControlProcedure or surgery
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 adhesiveProcedure or surgery
Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
| Study group | Role | What they receive |
|---|---|---|
| Unicirc with tissue adhesive | Experimental | Excision of foreskin with Unicirc device and sealing wound with tissue adhesive Receives: Procedure: Unicirc with tissue adhesive |
| Surgical control | Active comparator | Surgical circumcision using forceps guided, dorsal slit, or sleeve method Receives: Procedure: Surgical Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Duration
The number of minutes required to perform the surgical procedure
Measured: 1 hour
Secondary outcomes (4)
Number of Participants With Adverse Events
Bleeding, hematoma, infection and other rare adverse events
Measured: 1 month
Blood Loss
Number of ml of blood lost during the procedure, as assessed by the surgeon
Measured: During procedure (up to 1 hour)
Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks
The number of participants with complete epithelialization (completely healed) at 4 weeks
Measured: 1 month
Cosmetic Result
Regular: scar line straight without any irregularity
Irregular: Some irregularity to scar line
Scalloped: wavy appearane to scar line
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CircumcisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simunye Primary Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Millard, Simunye Primary Health Care
- Investigators
- Norman Goldstuck, MB ChB, Study director, Simunye Primary Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998360
- Sponsor's protocol ID
- Unicirc 002
- Status last verified
- Sep 2018
- First submitted
- 11 Oct 2013
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT01998360
- Acronym / sponsor ID
- Unicirc 002
- Conditions
- Circumcision
- Keywords
- Circumcision, Voluntary medical male circumcision, Minimally-invasive, HIV prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Simunye Primary Health CareUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 15 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unicirc with tissue adhesive | Experimental | Procedure: Unicirc with tissue adhesiveExcision of foreskin with Unicirc device and sealing wound with tissue adhesive |
| Surgical control | Active comparator | Procedure: Surgical ControlSurgical circumcision using forceps guided, dorsal slit, or sleeve method |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (5 listed)
- Current illness
- Penile abnormality or infection which contraindicates or would complicate circumcision
- History of bleeding disorder
- Past reaction to local anesthetic
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ControlThe 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. | Procedure or surgery | Surgical control |
| Unicirc with tissue adhesiveExcision of foreskin with Unicirc device and wound sealing with tissue adhesive | Procedure or surgery | Unicirc with tissue adhesive |
Primary outcome
Intraoperative Duration
Time frame: 1 hour
The number of minutes required to perform the surgical procedure
4 secondary outcomes
Number of Participants With Adverse Events
Time frame: 1 month
Blood Loss
Time frame: During procedure (up to 1 hour)
Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks
Time frame: 1 month
Cosmetic Result
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Goldstuck, MB ChB study director
Simunye Primary Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unicirc with tissue adhesive in people with Circumcision, run by Simunye Primary Health Care at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Duration (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.