- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03280628
Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Absorbable Sutures
Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.
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The patient's doctor will close the patient's laceration with absorbable sutures.
Other Names:
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Experimental: Steri-Strips
Patients will have their laceration closed with a special medical tape called "Steri-Strips."
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The patient's doctor will close the patient's laceration with Steri-Strips.
Other Names:
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Experimental: Dermabond
Patients will have their laceration closed with a special skin glue called "Dermabond"
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The patient's doctor will close the patient's laceration with Dermabond.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cosmetic Outcome of Scar at 3 Months
Time Frame: 3 months
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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"
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Experienced by Patient as Reported by Parent
Time Frame: Baseline
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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."
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Baseline
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Satisfaction With Time in the Emergency Department
Time Frame: Baseline to wound closure, up to 30 minutes
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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
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Baseline to wound closure, up to 30 minutes
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Likelihood That Parent Would Recommend Laceration Closure Method
Time Frame: Post-wound closure, approximately 30 minutes
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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"
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Post-wound closure, approximately 30 minutes
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Number of Complications of the Wound Site
Time Frame: 3 months
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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.
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3 months
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Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
Time Frame: 3 months
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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".
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3 months
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Presence of Train Tracks at the Scar Site
Time Frame: 3 months
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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".
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3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Holly R Hanson, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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