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OpenTrials
Completed

NCT Number: NCT03685565

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

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).

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Key information

Conditions

Facial Laceration Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dell Children's Hospital

Austin, Texas, 78723, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermabond and steristrips

Procedure

Laceration repaired with Dermabond with underlying steristrips

Dermabond

Procedure

Laceration repaired with Dermabond

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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