Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial
NCT ID: NCT04908137
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2021-04-01
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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
Control Group
will receive Vaseline cream application around the post-circumcision site immediately after circumcision
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Days
60 Days
MALE
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Michael Chua
Staff Urologist
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1000070281
Identifier Type: -
Identifier Source: org_study_id