Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of the study is to compare cosmetic outcomes of simple facial lacerations in children repaired with Dermabond (skin glue) compared with Dermabond (skin glue) with underlying steristrips (skin adhesive strips).

Official Title
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Cosmetic Outcomes of Simple Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips: A Randomized Controlled Trial

Conditions
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Facial Laceration

Intervention / Treatment
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* Procedure: Dermabond and steristrips
* Procedure: Dermabond


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≤17 years old Presents with simple, linear facial laceration requiring repair English or Spanish speaking parents or guardians Exclusion Criteria: Laceration to lips, nose, ear, eyelids, eyebrows Laceration requiring multi-layer closure Laceration requiring sub-specialty care Laceration that has previously been repaired Animal/human bites Lacerations >5cm in length Allergy to adhesive

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermabond with underlying steristrips<br> | Procedure: Dermabond and steristrips<br>* Laceration repaired with Dermabond with underlying steristrips<br>|
| Active Comparator: Dermabond<br> | Procedure: Dermabond<br>* Laceration repaired with Dermabond<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmesis | cosmetic scar outcome; photo will be taken of scar at 2 months and graded using a visual analog scale (VAS) by blinded reviewers. The VAS is a 0-100mm standardized scale where 0mm represents the worst scar and 100mm represents the best scar and reviewers will place a marking along the line of where they feel the scar belongs. | 2 months after repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to repair laceration | A stopwatch will be used to time how long it takes the physician to repair the wound | Day 0 (physician will complete just after the repair) | 
| Ease of repair of laceration | Physicians will complete a VAS (visual analog scale) on how easy the laceration was to repair. The VAS is a 0-100mm scale where 0 will represent very easy and 100mm will represent very difficult to repair and the physician will mark along the scale. | Day 0 (physician will complete just after the repair) | 
| Type of analgesia & sedation required | Physician will write down what types of analgesia they used and whether or not sedation was used after the repair is complete | Day 0 (physician will complete just after the repair) | 
| Wound dehiscence | Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed. | 1 week | 
| Wound infection | Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar, cosmesis, facial laceration, pediatric, dermabond, skin glue, steristrips, skin adhesive