Dermabond for Circumcision Complications

Overseen By Michael E Chua, MD

Age: < 18

Sex: Male

Trial Phase: Phase 3

Sponsor: The Hospital for Sick Children

Disqualifiers: Bleeding disorders, Genital anomalies, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: Immediate post-procedure

280 Participants Needed

Trial Summary

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 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

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

I am a male newborn eligible for circumcision without genital anomalies.

Consent provided by one of the parents

I do not have blood diseases like hemophilia.

Exclusion Criteria

Genital anomalies such as hypospadias, severe ventral curvatures

Known allergic reactions to components of the 2-Octyl Cyanoacrylate (Dermabond)

Family history of bleeding or clotting disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of 2-Octyl Cyanoacrylate (Dermabond) or Vaseline cream immediately after neonatal circumcision

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for complications, pain scores, and parents' satisfaction post-circumcision

180 days

Multiple assessments at 5 minutes, 30 minutes, 24 hours, 2 weeks, 30 days, and up to 180 days

Treatment Details

Interventions

• 2-octyl cyanoacrylate

Trial Overview The trial tests the safety and effectiveness of using Dermabond (2-Octyl Cyanoacrylate) on the circumcision site in newborns. It compares babies treated with Dermabond to those who aren't, looking at complication rates and pain within six months post-procedure.

Participant Groups

Group I: 2-Octyl Cyanoacrylate (Dermabond) Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

will receive Vaseline cream application around the post-circumcision site immediately after circumcision

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+