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

NCT03280628 | Terminated Results

• 1 other identifier: 171108
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Laceration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain Experienced by Patient as Reported by Parent

  Baseline

• Satisfaction With Time in the Emergency Department

  Baseline to wound closure, up to 30 minutes

• Likelihood That Parent Would Recommend Laceration Closure Method

  Post-wound closure, approximately 30 minutes

• Number of Complications of the Wound Site

  3 months

• Parental Reported Satisfaction With the Cosmetic Appearance of the Scar

  3 months

Study Arms (3)

Absorbable Sutures

ACTIVE COMPARATOR

Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.

Procedure: Absorbable Sutures

Steri-Strips

EXPERIMENTAL

Patients will have their laceration closed with a special medical tape called "Steri-Strips."

Procedure: Steri-Strips

Dermabond

EXPERIMENTAL

Patients will have their laceration closed with a special skin glue called "Dermabond"

Procedure: Dermabond

Interventions

Absorbable Sutures PROCEDURE

The patient's doctor will close the patient's laceration with absorbable sutures.

Also known as: Stitches

Absorbable Sutures

Steri-Strips PROCEDURE

The patient's doctor will close the patient's laceration with Steri-Strips.

Also known as: Medical tape

Steri-Strips

Dermabond PROCEDURE

The patient's doctor will close the patient's laceration with Dermabond.

Also known as: Skin glue

Dermabond

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Barton MS, Chaumet MSG, Hayes J, Hennessy C, Lindsell C, Wormer BA, Kassis SA, Ciener D, Hanson H. A Randomized Controlled Comparison of Guardian-Perceived Cosmetic Outcome of Simple Lacerations Repaired With Either Dermabond, Steri-Strips, or Absorbable Sutures. Pediatr Emerg Care. 2024 Oct 1;40(10):700-704. doi: 10.1097/PEC.0000000000003244. Epub 2024 Aug 2.

  PMID: 39141836 DERIVED

MeSH Terms

Conditions

Lacerations

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Early termination of the study due to limitation regarding the COVID-19 pandemic and prospective enrollment of pediatric patients in the Emergency Department. There were also only 55% of subjects who performed 3 month follow-up thus our primary outcome can only be measured on these subjects.

Results Point of Contact

• Title: Dr. Holly Hanson
• Organization: Vanderbilt University Medical Center

holly.r.hanson@vumc.org

615-936-7317

Study Officials

• Holly R Hanson, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Plastic Surgeons who rate all scars at the end of the study are blinded to the closure method.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 12, 2017
• Study Start: September 23, 2017
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)