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

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:

1. To assess post-procedural pain score difference between with versus without 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision
2. To assess parents' satisfaction and cosmesis post-neonatal circumcision with versus without 2-Octyl Cyanoacrylate (Dermabond) application.

Endpoints: Primary Endpoint: Complication rates post-neonatal circumcision within 180 days with the following complication in specific or in composite ⦁ Bleeding requiring hemostatic intervention (suturing, dermabond application, silver nitrite application, pressure bandage)

• Infection requiring antibiotic administration or wound drainage
• Excess skin as assessed by parents satisfaction
• Meatal stenosis
• Adhesion requiring surgical correction.

Secondary Endpoints:

1. pain score within 5 min and 30 minutes postneonatal circumcision using the FLACC score by parents and MBPS scale by a medical allied personnel.
2. 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).

Study Population: 280 male neonates (140 each intervention groups) who are eligible for neonatal circumcision with no other medical co-morbidities.

Intervention:

2-Octyl Cyanoacrylate (Dermabond) 0.5ml/ sticks) topical application around post-circumcision site subcoronal area.

Study Overview

• Status: Recruiting
• Conditions: Redundant Prepuce
• Intervention / Treatment: Drug: 2-octyl cyanoacrylate

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Michael E Chua, MD; Phone Number: 4168136899; Email: michael.chua@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Katie Baker; Phone Number: 4168136917; Email: katie.baker@sickkids.ca
      • Contact: Barbara Pannozzo, RN; Phone Number: 4168136917; Email: urology.nurses@sickkids.ca
      • Principal Investigator: Joana Dos Santos, MD FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2-Octyl Cyanoacrylate (Dermabond) Group; 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; 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; Other Names: Dermabond
NO_INTERVENTION: Control Group; will receive Vaseline cream application around the post-circumcision site immediately after circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rates (Composite)	Composite complication rates post-neonatal circumcision within 180 days following neonatal circumcision	180 days post neonatal circumcision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score (FLACC) by Parents	pain score within 5 minutes post-neonatal circumcision using the FLACC score by parents. (Higher Score is Worse)	5 minutes and 30 minutes
Pain score (MBPS) by Medical Personnel	pain score within 5 minutes and 30 minutes post-neonatal circumcision using the MBPS scale by a medical allied personnel. (Higher Score is Worse)	5 minutes and 30 minutes
Parents Satisfaction	Parents satisfaction as determined by a simple 10-score liked scale and cosmetic assessment scale within 24hours and within 30 days post-neonatal circumcision	within 24 hours and 30 days post neonatal circumcision
Complication rates (specific case characteristics)	Complication rates post-neonatal circumcision	within 24 hours, within 2 weeks, within 30 days within 30 to 180 days

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (ACTUAL): June 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Circumcision
• Other Study ID Numbers: 1000070281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No