Dermabond for Circumcision Complications
What You Need to Know Before You Apply
What is the purpose of this 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 circumcision2. 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.
Are You a Good Fit for This Trial?
This trial is for male newborns aged 2 to 60 days in good health, eligible for circumcision without genital anomalies or a family history of bleeding disorders. Babies with known allergies to Dermabond, clotting issues, recent febrile illness, or conditions that could affect study participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Application of 2-Octyl Cyanoacrylate (Dermabond) or Vaseline cream immediately after neonatal circumcision
Follow-up
Participants are monitored for complications, pain scores, and parents' satisfaction post-circumcision
What Are the Treatments Tested in This Trial?
Interventions
- 2-octyl cyanoacrylate
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Hospital for Sick Children
Lead Sponsor