Clinical Trials Directory

Trials / Terminated

TerminatedNCT03280628

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAbsorbable SuturesThe patient's doctor will close the patient's laceration with absorbable sutures.
PROCEDURESteri-StripsThe patient's doctor will close the patient's laceration with Steri-Strips.
PROCEDUREDermabondThe patient's doctor will close the patient's laceration with Dermabond.

Timeline

Start date
2017-09-23
Primary completion
2021-02-01
Completion
2021-02-01
First posted
2017-09-12
Last updated
2023-07-17
Results posted
2023-07-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03280628. Inclusion in this directory is not an endorsement.