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

University of Texas at Austin1 site in 1 country120 target enrollmentSeptember 15, 2018

ConditionsFacial Laceration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Facial Laceration
Sponsor: University of Texas at Austin
Enrollment: 120
Locations: 1
Primary Endpoint: Cosmesis
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 15, 2018

End Date

January 15, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Texas at Austin

Responsible Party

Principal Investigator

Erin D Munns

Fellow Physician

University of Texas at Austin

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Ease of repair of laceration(Day 0 (physician will complete just after the repair))
Time to repair 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)