PhimosisNCT06487494
Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult Male Circumcision
A study testing Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures and Circumcision wound closure using continuous sutuing in people with Phimosis and Paraphimosis, run by University of Manitoba at 1 site in Canada.
Trial summary
This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of… Read more about this study
- Who is it for?
- Ages 16 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Phimosis, Paraphimosis
- What is being tested?
- Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures and Circumcision wound closure using continuous sutuing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2024to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 80 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients >16 years of age undergoing circumcision will be included.
Who cannot join
- Patients <16 years of age who did not provide consent to be randomized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures Non-inferior to Continuous Suturing as a Wound Closure Technique in Adult Male Circumcision: A Randomized Controlled Pilot Study
This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. To the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. Additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.
Read the detailed description
This non-blinded, randomized controlled pilot study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients undergoing circumcision will be invited to participate in the study. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. Patients will be randomized to 2-Octyl cyanoacrylate (2-OCA) with four interrupted sutures vs. standard suturing alone. In the post-operative recovery area, patients will be asked to complete a VAS questionnaire. Patients will then be brought in for their routine visit 6 weeks post-op. During the visit, closure of the wound as well as any potential complications will be assessed by a research team member. At that time, a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision. Cosmesis and complications will also be assessed 12 weeks post-op.
- Conditions
- Phimosis, Paraphimosis
- Being tested
- Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures, Circumcision wound closure using continuous sutuing
- Medical subject headings
- Phimosis, Paraphimosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted suturesProcedure or surgery
2-octyl cyanoacrylate glue is a wound closure adhesive which will be used with four interrupted sutures following circumcision for wound closure.
Circumcision wound closure using continuous sutuingProcedure or surgery
Continuous suturing is the standard following circumcision for wound closure.
| Study group | Role | What they receive |
|---|---|---|
| 2-octyl cyanoacrylate glue with four interrupted sutures | Experimental | In this arm the provider will use 2-octyl cyanoacrylate glue with four interrupted sutures for wound closing following circumcision. Receives: Procedure: Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures |
| Continuous suture | Active comparator | In this arm the provider will use continuous suturing for wound closing following circumcision. Receives: Procedure: Circumcision wound closure using continuous sutuing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmesis
A cosmetic appearance satisfaction questionnaire will be administered at weeks 6 and 12 post-operation.
Measured: 6 and 12 weeks post-operation
Post-operative Pain
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient to determine their pain.
Measured: Immediately post-operation and 6 weeks post-operation
Complication Rate
Measuring and recording any adverse events post procedure such as surgical site infection, bleeding, hematoma, diffuse swelling, and increased sensitivity amidst intercourse.
Measured: 6 and 12 weeks post-operation
Intra-Operative Time
Intra-operative time will be measured starting when the physician makes the first incision and ends when sutures are finished.
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start26 Aug 2024
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhimosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premal Patel, MD, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487494
- Sponsor's protocol ID
- HS26545
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures Non-inferior to Continuous Suturing as a Wound Closure Technique in Adult Male Circumcision: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06487494
- Acronym / sponsor ID
- HS26545
- Conditions
- Phimosis, Paraphimosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. To the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. Additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.
Detailed description
This non-blinded, randomized controlled pilot study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients undergoing circumcision will be invited to participate in the study. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. Patients will be randomized to 2-Octyl cyanoacrylate (2-OCA) with four interrupted sutures vs. standard suturing alone. In the post-operative recovery area, patients will be asked to complete a VAS questionnaire. Patients will then be brought in for their routine visit 6 weeks post-op. During the visit, closure of the wound as well as any potential complications will be assessed by a research team member. At that time, a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision. Cosmesis and complications will also be assessed 12 weeks post-op.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-octyl cyanoacrylate glue with four interrupted sutures | Experimental | Procedure: Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted suturesIn this arm the provider will use 2-octyl cyanoacrylate glue with four interrupted sutures for wound closing following circumcision. |
| Continuous suture | Active comparator | Procedure: Circumcision wound closure using continuous sutuingIn this arm the provider will use continuous suturing for wound closing following circumcision. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >16 years of age undergoing circumcision will be included.
Key exclusion criteria (1 listed)
- Patients <16 years of age who did not provide consent to be randomized.
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 |
|---|---|---|
| Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures2-octyl cyanoacrylate glue is a wound closure adhesive which will be used with four interrupted sutures following circumcision for wound closure. | Procedure or surgery | 2-octyl cyanoacrylate glue with four interrupted sutures |
| Circumcision wound closure using continuous sutuingContinuous suturing is the standard following circumcision for wound closure. | Procedure or surgery | Continuous suture |
Primary outcome
Cosmesis
Time frame: 6 and 12 weeks post-operation
A cosmetic appearance satisfaction questionnaire will be administered at weeks 6 and 12 post-operation.
Post-operative Pain
Time frame: Immediately post-operation and 6 weeks post-operation
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient to determine their pain.
Complication Rate
Time frame: 6 and 12 weeks post-operation
Measuring and recording any adverse events post procedure such as surgical site infection, bleeding, hematoma, diffuse swelling, and increased sensitivity amidst intercourse.
Intra-Operative Time
Time frame: During the operation
Intra-operative time will be measured starting when the physician makes the first incision and ends when sutures are finished.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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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 study testing Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures and Circumcision wound closure using continuous sutuing in people with Phimosis and Paraphimosis, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 1 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 5 Sep 2025. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cosmesis (time frame: 6 and 12 weeks post-operation). The study lists 4 primary outcomes in all. 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 5 Sep 2025.