Recruiting
Phase 3

2-Octyl Cyanoacrylate

Sponsor:

The Hospital for Sick Children

Code:

NCT04908137

Conditions

Redundant Prepuce

Eligibility Criteria

Sex: Male

Age: 0

Healthy Volunteers: Not accepted

Interventions

2-octyl cyanoacrylate

Study Details

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.

Conditions

Redundant Prepuce

Study ID

NCT04908137

Start date

Apr 1, 2021

Status verified date

Oct, 2021

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Mar 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: Control Group

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

Interventions

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

Primary outcome measure

  • Complication rates (Composite) [ Time Frame: 180 days post neonatal circumcision ]

Central Contacts and Locations

Central contacts

Michael E Chua, MD

4168136899michael.chua@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Katie Baker

4168136917katie.baker@sickkids.ca

Barbara Pannozzo, RN

4168136917urology.nurses@sickkids.ca

Principal Investigator:

Joana Dos Santos, MD FRCPC

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Oct 15, 2021

Last verified

Oct, 2021

Keywords

  • Circumcision

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2021-10-15.