NCT03685565

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

September 17, 2018

Last Update Submit

January 31, 2020

Conditions

Facial Laceration

Keywords

facial lacerationpediatricdermabondskin gluesteristripsskin adhesivescarcosmesis

Outcome Measures

Primary Outcomes (1)

  • Cosmesis

    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 Outcomes (5)

  • Time to repair laceration

    Day 0 (physician will complete just after the repair)

  • Ease of repair of laceration

    Day 0 (physician will complete just after the repair)

  • Type of analgesia & sedation required

    Day 0 (physician will complete just after the repair)

  • Wound dehiscence

    1 week

  • Wound infection

    1 week

Study Arms (2)

Dermabond with underlying steristrips

EXPERIMENTAL
Procedure: Dermabond and steristrips

Dermabond

ACTIVE COMPARATOR
Procedure: Dermabond

Interventions

Dermabond and steristripsPROCEDURE

Laceration repaired with Dermabond with underlying steristrips

Dermabond with underlying steristrips
DermabondPROCEDURE

Laceration repaired with Dermabond

Dermabond

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dell Children's Hospital

Austin, Texas, 78723, United States

Location

Related Publications (1)

  • Munns E, Kienstra AJ, Combs PD, Gabriele G, Wilkinson M. Cosmetic Outcomes of Simple Pediatric Facial Lacerations Repaired With Skin Adhesive Compared With Skin Adhesive With Underlying Adhesive Strips: A Randomized Controlled Trial. Pediatr Emerg Care. 2022 Oct 1;38(10):477-480. doi: 10.1097/PEC.0000000000002837. Epub 2022 Aug 26.

    PMID: 36018733DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Erin Munns, MD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow Physician

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 26, 2018

Study Start

September 15, 2018

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)