Clinical trial NCT03280628: Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laceration
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 55
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cosmetic Outcome of Scar at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Pain Experienced by Patient as Reported by Parent
timeFrame: Baseline
measure: Satisfaction With Time in the Emergency Department
timeFrame: Baseline to wound closure, up to 30 minutes
measure: Likelihood That Parent Would Recommend Laceration Closure Method
timeFrame: Post-wound closure, approximately 30 minutes
measure: Number of Complications of the Wound Site
timeFrame: 3 months
measure: Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
timeFrame: 3 months
measure: Presence of Train Tracks at the Scar Site
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Holly R Hanson, MD
role: PRINCIPAL_INVESTIGATOR
References: