Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches

Study Overview
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Brief Summary
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There are several methods of closing a skin cut: stitches, skin glue, and medical tape. Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s) and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The purpose of this study is to find out which method (stitches, skin glue, or medical tape) of closing skin cuts results in the least amount of scarring. Other things the investigators will be looking at are which method is the cheapest, which causes the least pain, which requires the least amount of sedation, and which method patients and parents like the best.

Detailed Description
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When a child comes in to the Emergency Room with a skin cut, if the child and their parents consent to being in the study, they will be randomly assigned to one of three groups: stitches, skin glue, or medical tape. There will be about 30 kids in each group, and thus a goal of 90 kids total in the study. In the Emergency Room, a lidocaine ointment will be placed on the child's cut to decrease pain. The cut will be cleaned out with sterile saline. Then, depending on which method is used, the cut will be closed with either stitches, skin glue, or medical tape by their doctor. The participants will be asked to answer a short questionnaire. Finally, they will be given discharge instructions and sent home. At 3 months, the investigators will call parents for a quick questionnaire over the phone and parents will be asked to take a picture of the patient's scar and send it to the study staff. Once all 90 pictures have been collected, two Plastic Surgeons will be asked to rate the scars in terms of how they look. The Plastic Surgeons will not know which method was used to close which cut. Once all of the scars have been rated, the averages of scars will be compared for each closure method. The investigators will also look at how much each method cost, how much extra pain medications or sedation each group used, and which method was liked best.

Official Title
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A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures

Conditions
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Laceration

Intervention / Treatment
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* Procedure: Absorbable Sutures
* Procedure: Steri-Strips
* Procedure: Dermabond


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical complaint of laceration Single, linear laceration Laceration less than 5 cm in length and 0.5 cm in width Laceration less than 12 hours old Laceration minimally contaminated (no visible dirt in wound) Parents and child speak English Exclusion Criteria: Significant medical history that may impact wound healing (hematologic or oncologic diagnosis requiring chemotherapy, ichthyosis, epidermolysis bullosa, etc.) Use of oral steroids (more than 5 days in the past month) History of keloid formation Allergy to skin glue, medical tape, or topical anesthetics Lacerations requiring deep sutures Lacerations caused by animal bites or scratches Lacerations located on the scalp, eyebrow, eyelid, lip, mucosa, joint or nail bed No access to photographic capabilities (camera or smartphone) and/or e-mail, OR unable to return to the Vanderbilt Children's Hospital Emergency Room to have a picture taken at 3 months

Ages Eligible for Study
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Maximum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Absorbable Sutures<br>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed. | Procedure: Absorbable Sutures<br>* The patient's doctor will close the patient's laceration with absorbable sutures.<br>* Other names: Stitches;|
| Experimental: Steri-Strips<br>Patients will have their laceration closed with a special medical tape called Steri-Strips. | Procedure: Steri-Strips<br>* The patient's doctor will close the patient's laceration with Steri-Strips.<br>* Other names: Medical tape;|
| Experimental: Dermabond<br>Patients will have their laceration closed with a special skin glue called Dermabond | Procedure: Dermabond<br>* The patient's doctor will close the patient's laceration with Dermabond.<br>* Other names: Skin glue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Outcome of Scar at 3 Months | Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to worst scar and a score of 100 corresponding to best scar | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Experienced by Patient as Reported by Parent | Parents will each be asked to score how much pain they felt the patient experienced using a 100 mm Visual Analogue Scale with a score of 0 corresponding to No pain and a score of 100 corresponding to Terrible pain. | Baseline | 
| Satisfaction With Time in the Emergency Department | Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with 100 meaning completely satisfied and 0 meaning not at all satisfied | Baseline to wound closure, up to 30 minutes | 
| Likelihood That Parent Would Recommend Laceration Closure Method | Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to Extremely unlikely and a score of 100 corresponding to Extremely likely | Post-wound closure, approximately 30 minutes | 
| Number of Complications of the Wound Site | Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.). Investigators will count the number of complications reported. | 3 months | 
| Parental Reported Satisfaction With the Cosmetic Appearance of the Scar | Parents will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to worst scar and a score of 100 corresponding to best scar. | 3 months | 
| Presence of Train Tracks at the Scar Site | Plastic Surgeons will record if a scar appears to have train tracks (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each photo of the scar at 3 months post-closure. Surgeons will answer yes or no. | 3 months |