Clinical trial NCT04908137: Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial
Official title: Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Redundant Prepuce
Keywords: Circumcision
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 280
Sex: MALE
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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 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.

Primary outcomes:
measure: Complication rates (Composite)
timeFrame: 180 days post neonatal circumcision
Secondary outcomes:
measure: Pain score (FLACC) by Parents
timeFrame: 5 minutes and 30 minutes
measure: Pain score (MBPS) by Medical Personnel
timeFrame: 5 minutes and 30 minutes
measure: Parents Satisfaction
timeFrame: within 24 hours and 30 days post neonatal circumcision
measure: Complication rates (specific case characteristics)
timeFrame: within 24 hours, within 2 weeks, within 30 days within 30 to 180 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: