Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Recruiting

CT.gov ID

NCT04908137

Collaborator

(none)

280

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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:

To assess post-procedural pain score difference between with versus without 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision
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:

pain score within 5 min and 30 minutes postneonatal circumcision using the FLACC score by parents and MBPS scale by a medical allied personnel.
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.

Condition or Disease	Intervention/Treatment	Phase
Redundant Prepuce	Drug: 2-octyl cyanoacrylate	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: 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 Names: Dermabond
No Intervention: Control Group will receive Vaseline cream application around the post-circumcision site immediately after circumcision

Arm

Intervention/Treatment

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

Drug: 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 Names:

Dermabond

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

Complication rates (Composite) [180 days post neonatal circumcision]
Composite complication rates post-neonatal circumcision within 180 days following neonatal circumcision

Secondary Outcome Measures

Pain score (FLACC) by Parents [5 minutes and 30 minutes]
pain score within 5 minutes post-neonatal circumcision using the FLACC score by parents. (Higher Score is Worse)
Pain score (MBPS) by Medical Personnel [5 minutes and 30 minutes]
pain score within 5 minutes and 30 minutes post-neonatal circumcision using the MBPS scale by a medical allied personnel. (Higher Score is Worse)
Parents Satisfaction [within 24 hours and 30 days post neonatal circumcision]
Parents satisfaction as determined by a simple 10-score liked scale and cosmetic assessment scale within 24hours and within 30 days post-neonatal circumcision
Complication rates (specific case characteristics) [within 24 hours, within 2 weeks, within 30 days within 30 to 180 days]
Complication rates post-neonatal circumcision

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Days to 60 Days

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Chua, Staff Urologist, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT04908137

Other Study ID Numbers:

1000070281

First Posted:

Jun 1, 2021

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Michael Chua, Staff Urologist, The Hospital for Sick Children

Circumcision

Study Results

No Results Posted as of Oct 15, 2021