Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial

NCT04908137 | Unknown Phase 3 DMC

• 1 other identifier: 1000070281
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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 efficacy and safety. This is a single-centered, randomized clinical trial to assess the efficacy and safety of 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision to prevent complication. Primary Objective: To determine the efficacy and safety of 2-Octyl Cyanoacrylate (Dermabond) application versus control in neonatal circumcision to prevent post-procedural complication. Secondary Objectives:

• Infection requiring antibiotic administration or wound drainage
• Excess skin as assessed by parents satisfaction
• Meatal stenosis
• Adhesion requiring surgical correction. Secondary Endpoints:
• pain score within 5 min and 30 minutes postneonatal circumcision using the FLACC score by parents and MBPS scale by a medical allied personnel.
• Parents satisfaction as determined by a simple 10-score liked scale and cosmesis assessment scale within 24hrs and within 30 days post-neonatal circumcision. Complication rates detailed above in specific time points clustered according to (within 24 hrs, within 2 weeks, within 30 days, within 30 to 180 days).

Conditions

Redundant Prepuce

Keywords

Circumcision

Outcome Measures

Primary Outcomes (1)

• Complication rates (Composite)

  Composite complication rates post-neonatal circumcision within 180 days following neonatal circumcision

  180 days post neonatal circumcision

Secondary Outcomes (4)

• Pain score (FLACC) by Parents

  5 minutes and 30 minutes

• Pain score (MBPS) by Medical Personnel

  5 minutes and 30 minutes

• Parents Satisfaction

  within 24 hours and 30 days post neonatal circumcision

• Complication rates (specific case characteristics)

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

Study Arms (2)

2-Octyl Cyanoacrylate (Dermabond) Group

EXPERIMENTAL

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

Drug: 2-octyl cyanoacrylate

Control Group

NO INTERVENTION

will receive Vaseline cream application around the post-circumcision site immediately after circumcision

Interventions

2-octyl cyanoacrylate DRUG

Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D \& C Violet No. 2. It is provided as a single use applicator in a blister package

Also known as: Dermabond

2-Octyl Cyanoacrylate (Dermabond) Group

Eligibility Criteria

• Age: 2 Days - 60 Days
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Interventions

octyl 2-cyanoacrylate

Central Study Contacts

Michael E Chua, MD

CONTACT

4168136899; michael.chua@sickkids.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Urologist

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: December 31, 2024
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)