← Back to Search

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

Must not have

Presence of bleeding or clotting disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours, within 2 weeks, within 30 days within 30 to 180 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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

Select...

I do not have blood diseases like hemophilia.

Select...

I am between 2 and 60 days old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a bleeding or clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours and 30 days post neonatal circumcision

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complication rates (Composite)

Secondary study objectives

Complication rates (specific case characteristics)

Pain score (FLACC) by Parents

Pain score (MBPS) by Medical Personnel

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met