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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:
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)
Secondary Endpoints:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Octyl Cyanoacrylate (Dermabond) Group | Experimental | 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 |
|
| Control Group | No Intervention | will receive Vaseline cream application around the post-circumcision site immediately after circumcision |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-octyl cyanoacrylate | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rates (Composite) | Composite complication rates post-neonatal circumcision within 180 days following neonatal circumcision | 180 days post neonatal circumcision |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score (FLACC) by Parents | pain score within 5 minutes post-neonatal circumcision using the FLACC score by parents. (Higher Score is Worse) | 5 minutes and 30 minutes |
| Pain score (MBPS) by Medical Personnel |
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Inclusion Criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael E Chua, MD | Contact | 4168136899 | michael.chua@sickkids.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| C100832 | octyl 2-cyanoacrylate |
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pain score within 5 minutes and 30 minutes post-neonatal circumcision using the MBPS scale by a medical allied personnel. (Higher Score is Worse)
| 5 minutes and 30 minutes |
| Parents Satisfaction | Parents satisfaction as determined by a simple 10-score liked scale and cosmetic assessment scale within 24hours and within 30 days post-neonatal circumcision | within 24 hours and 30 days post neonatal circumcision |
| Complication rates (specific case characteristics) | Complication rates post-neonatal circumcision | within 24 hours, within 2 weeks, within 30 days within 30 to 180 days |