Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult M… (NCT06487494) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult Male Circumcision
Canada20 participantsStarted 2024-08-26
Plain-language 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 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.
Who can participate
Age range
16 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients \>16 years of age undergoing circumcision will be included.
Exclusion Criteria:
* Patients \<16 years of age who did not provide consent to be randomized.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared 2-octyl cyanoacrylate tissue glue with just four interrupted sutures to close the wound after circumcision — how does that approach compare to the standard suturing technique my surgeon would normally use, and what are the potential trade-offs in terms of healing?
2Since this trial has already completed and measured things like complication rates and post-operative pain, has my doctor seen or reviewed any of the published results, and do they change how they'd recommend closing the wound in my case?
3The trial was specifically done in adult males with phimosis or paraphimosis — given my specific diagnosis, does my doctor think the findings from this study would be relevant to my situation, or are there differences in my case that might make standard techniques a better fit?
4Because the trial tracked cosmetic outcomes as a primary measure, what does that actually mean for how the scar or wound site looks long-term, and is that something I should factor into my decision about which closure method to discuss with my surgeon?
5Given that this was a Phase NA study — meaning it wasn't a standard drug-safety phase trial — how confident is my doctor in the evidence behind using tissue glue combined with fewer sutures, and would they feel comfortable offering me that approach based on what's currently known?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cosmesis
Timeframe: 6 and 12 weeks post-operation
2
Post-operative Pain
Timeframe: Immediately post-operation and 6 weeks post-operation