Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients

January 31, 2020 updated by: Erin D Munns, University of Texas at Austin

Cosmetic Outcomes of Simple Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips: A Randomized Controlled Trial

The purpose of the study is to compare cosmetic outcomes of simple facial lacerations in children repaired with Dermabond (skin glue) compared with Dermabond (skin glue) with underlying steristrips (skin adhesive strips).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≤17 years old
  • Presents with simple, linear facial laceration requiring repair
  • English or Spanish speaking parents or guardians

Exclusion Criteria:

  • Laceration to lips, nose, ear, eyelids, eyebrows
  • Laceration requiring multi-layer closure
  • Laceration requiring sub-specialty care
  • Laceration that has previously been repaired
  • Animal/human bites
  • Lacerations >5cm in length
  • Allergy to adhesive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dermabond with underlying steristrips
Procedure: Dermabond and steristrips
Laceration repaired with Dermabond with underlying steristrips
Active Comparator: Dermabond
Procedure: Dermabond
Laceration repaired with Dermabond

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmesis
Time Frame: 2 months after repair
cosmetic scar outcome; photo will be taken of scar at 2 months and graded using a visual analog scale (VAS) by blinded reviewers. The VAS is a 0-100mm standardized scale where 0mm represents the "worst scar" and 100mm represents the "best scar" and reviewers will place a marking along the line of where they feel the scar belongs.
2 months after repair

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to repair laceration
Time Frame: Day 0 (physician will complete just after the repair)
A stopwatch will be used to time how long it takes the physician to repair the wound
Day 0 (physician will complete just after the repair)
Ease of repair of laceration
Time Frame: Day 0 (physician will complete just after the repair)
Physicians will complete a VAS (visual analog scale) on how easy the laceration was to repair. The VAS is a 0-100mm scale where 0 will represent "very easy" and 100mm will represent "very difficult" to repair and the physician will mark along the scale.
Day 0 (physician will complete just after the repair)
Type of analgesia & sedation required
Time Frame: Day 0 (physician will complete just after the repair)
Physician will write down what types of analgesia they used and whether or not sedation was used after the repair is complete
Day 0 (physician will complete just after the repair)
Wound dehiscence
Time Frame: 1 week
Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.
1 week
Wound infection
Time Frame: 1 week
Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Erin Munns, MD, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05-0081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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