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Tissue Adhesive

Dermabond for Circumcision Complications

Phase 3
Recruiting
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of hematological diseases with clotting or bleeding disorders such as hemophilia, Von Willebrand diseases
Aged 2 to 60 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours, within 2 weeks, within 30 days within 30 to 180 days
Awards & highlights

Study Summary

This trial is testing whether 2-Octyl Cyanoacrylate (Dermabond), a medical adhesive, can help to prevent complications in neonatal circumcision.

Who is the study for?
This trial is for male newborns aged 2 to 60 days in good health, eligible for circumcision without genital anomalies or a family history of bleeding disorders. Babies with known allergies to Dermabond, clotting issues, recent febrile illness, or conditions that could affect study participation are excluded.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of using Dermabond (2-Octyl Cyanoacrylate) on the circumcision site in newborns. It compares babies treated with Dermabond to those who aren't, looking at complication rates and pain within six months post-procedure.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Dermabond components, infection requiring antibiotics or drainage, excess skin affecting parental satisfaction, meatal stenosis (narrowing), adhesion needing surgical correction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have blood diseases like hemophilia.
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I am between 2 and 60 days old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours and 30 days post neonatal circumcision
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours and 30 days post neonatal circumcision for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complication rates (Composite)
Secondary outcome measures
Complication rates (specific case characteristics)
Pain score (FLACC) by Parents
Pain score (MBPS) by Medical Personnel
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2-Octyl Cyanoacrylate (Dermabond) GroupExperimental Treatment1 Intervention
2-Octyl Cyanoacrylate (Dermabond) 0.5ml/ sticks topical application around post-circumcision site subcoronal area immediately after the circumcision devise is removed and circumcision procedure was done
Group II: Control GroupActive Control1 Intervention
will receive Vaseline cream application around the post-circumcision site immediately after circumcision

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
690 Previous Clinical Trials
6,945,198 Total Patients Enrolled

Media Library

2-octyl cyanoacrylate (Tissue Adhesive) Clinical Trial Eligibility Overview. Trial Name: NCT04908137 — Phase 3
Phimosis Research Study Groups: 2-Octyl Cyanoacrylate (Dermabond) Group, Control Group
Phimosis Clinical Trial 2023: 2-octyl cyanoacrylate Highlights & Side Effects. Trial Name: NCT04908137 — Phase 3
2-octyl cyanoacrylate (Tissue Adhesive) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908137 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared 2-octyl cyanoacrylate for sale and use?

"2-octyl cyanoacrylate has been studied in multiple Phase 3 trials, meaning that there is both efficacy and safety data available. As such, our team has decided to rate it as a 3 in terms of safety."

Answered by AI

What existing research exists on 2-octyl cyanoacrylate?

"There are currently 2 clinical trials testing 2-octyl cyanoacrylate with 1 in Phase 3. Most of these tests are being conducted in Vancouver, British Columbia, but there are also 2 other locations running similar trials."

Answered by AI

Does this study involve any geriatric patients?

"This study is only for infants aged 2 days to 60 days old."

Answered by AI

Who would be the ideal candidate for this clinical trial?

"This study is for infants with redundant prepuce who are between 2 days and 60 days old--approximately 280 patients will be accepted."

Answered by AI

Are there any more open positions for participants in this trial?

"This study is currently recruiting patients, according to the information on clinicaltrials.gov. The study was originally posted on April 1, 2021, and was last edited on October 8, 2021."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial
Michael Chua 2021. "Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908137.
~70 spots leftby Apr 2025
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