Status:
UNKNOWN
Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Redundant Prepuce
Eligibility:
MALE
2-60 years
Phase:
PHASE3
Brief Summary
Study Description: 2-Octyl Cyanoacrylate (Dermabond) use in neonatal circumcision are being practiced to prevent complications; however, no randomized controlled trials was ever done to assess efficac...
Eligibility Criteria
Inclusion
- Consent provided by one of the parents
- Male sex eligible for neonatal circumcision (with no genital anomalies, such as hypospadias components or congenital curvatures)
- Aged 2 to 60 days
- In good general health as evidenced by medical history
- No history of hematological diseases with clotting or bleeding disorders such as hemophilia, Von Willebrand diseases
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Presence of bleeding or clotting disorders
- Family history of bleeding or clotting disorder
- Genital anomalies such as hypospadias, severe ventral curvatures
- Known allergic reactions to components of the 2-Octyl Cyanoacrylate (Dermabond)
- Febrile illness within 48hrs
- Any condition or diagnosis, that could in the opinion of the Principal Investigator or the delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04908137
Start Date
April 1 2021
End Date
December 31 2024
Last Update
October 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8