Circumcision, MalePhase 4Unicirc004NCT02443792
Unicirc vs Open Surgical Circumcision
A Phase 4 study testing Unicirc with tissue adhesive and Open Surgical in people with Circumcision, Male, run by Simunye Primary Health Care at 1 site in South Africa.
Trial summary
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Unicirc with tissue adhesive and Open Surgical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2015to Sep 2015
- Phase
- Phase 4
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male
- Uncircumcised
- With normal penile anatomy
Who cannot join
- Concurrent illness
- History of bleeding disorder
- Past reaction to local anesthetic
- Infection
- Penile abnormality which could complicate circumcision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
- Conditions
- Circumcision, Male
- Being tested
- Unicirc with tissue adhesive, Open Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicirc with tissue adhesiveProcedure or surgery
As above
Open SurgicalProcedure or surgery
As above
| Study group | Role | What they receive |
|---|---|---|
| Unicirc with tissue adhesive | Experimental | Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Receives: Procedure: Unicirc with tissue adhesive |
| Open Surgical | Active comparator | Open surgical circumcision under local anesthetic with suturing Receives: Procedure: Open Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing
Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing
Measured: Up to 30 minutes
Secondary outcomes (4)
Surgical Pain 0=no Pain; 10=Worst Pain Ever
Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever
Measured: Up to 30 minutes
Completely Healed at 4 Weeks
Number of participants who were completely healed at 4 weeks
Measured: At the 4-week followup visit
Wound Dehiscence
Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)
Measured: Up to 4 weeks
Infection
Proportion experiencing post-op infection, determined clinically (treated with antibiotics)
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Circumcision, MaleStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simunye Primary Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Shenje, MB ChB, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443792
- Sponsor's protocol ID
- Unicirc004
- Acronym
- Unicirc004
- Status last verified
- Sep 2018
- First submitted
- 10 Apr 2015
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
PubMed 25822727Shenje J, Millard PS. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument. PLoS One. 2016 Jun 14;11(6):e0157065. doi: 10.1371/journal.pone.0157065. eCollection 2016.
PubMed 27299735
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02443792
- Acronym / sponsor ID
- Unicirc004 / Unicirc004
- Conditions
- Circumcision, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Simunye Primary Health CareUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Posted 20 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
Study design
- Primary purpose
- Prevention
- Allocation
- 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 adhesiveUnicirc under topical anesthetic w/ cyanoacrylate wound sealing |
| Open Surgical | Active comparator | Procedure: Open SurgicalOpen surgical circumcision under local anesthetic with suturing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male
- Uncircumcised
- With normal penile anatomy
Key exclusion criteria (5 listed)
- Concurrent illness
- History of bleeding disorder
- Past reaction to local anesthetic
- Infection
- Penile abnormality which could complicate circumcision
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 |
|---|---|---|
| Unicirc with tissue adhesiveAs above | Procedure or surgery | Unicirc with tissue adhesive |
| Open SurgicalAs above | Procedure or surgery | Open Surgical |
Primary outcome
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing
Time frame: Up to 30 minutes
Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing
4 secondary outcomes
Surgical Pain 0=no Pain; 10=Worst Pain Ever
Time frame: Up to 30 minutes
Completely Healed at 4 Weeks
Time frame: At the 4-week followup visit
Wound Dehiscence
Time frame: Up to 4 weeks
Infection
Time frame: Up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25822727Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
- Derived from this study: PubMed 27299735Shenje J, Millard PS. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument. PLoS One. 2016 Jun 14;11(6):e0157065. doi: 10.1371/journal.pone.0157065. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unicirc with tissue adhesive and Open Surgical in people with Circumcision, Male, 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 3 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 3 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2016). 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?
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02443792, which also lists 2 linked publications.
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 3 Oct 2018; AzTrials last refreshed its copy on 28 Oct 2026.