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

Laceration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03280628
• Other study ID #: 171108
• Status: Terminated
• Phase: N/A
• Start date: September 23, 2017
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Laceration
• Lacerations

Intervention

Procedure:
• Absorbable Sutures
The patient's doctor will close the patient's laceration with absorbable sutures.
• Steri-Strips
The patient's doctor will close the patient's laceration with Steri-Strips.
• Dermabond
The patient's doctor will close the patient's laceration with Dermabond.

Locations

Country	Name	City	State
United States	Vanderbilt Children's Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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