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

Last updated: October 8, 2021
Sponsor: The Hospital for Sick Children
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04908137
1000070281
  • Ages < 60
  • Male

Study 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:

  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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consent provided by one of the parents
  • Male sex eligible for neonatal circumcision (with no genital anomalies, such ashypospadias 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 ashemophilia, Von Willebrand diseases

Exclusion

Exclusion Criteria:

  • An individual who meets any of the following criteria will be excluded fromparticipation 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 PrincipalInvestigator or the delegate interfere with the participant's ability to complywith study instructions, might confound the interpretation of the study results,or put the participant at risk.

Study Design

Total Participants: 280
Study Start date:
April 01, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

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