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

NCT ID: NCT03685565

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2020-01-15

Brief Summary

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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).

Detailed Description

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Conditions

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Facial Laceration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dermabond with underlying steristrips

Group Type EXPERIMENTAL

Dermabond and steristrips

Intervention Type PROCEDURE

Laceration repaired with Dermabond with underlying steristrips

Dermabond

Group Type ACTIVE_COMPARATOR

Dermabond

Intervention Type PROCEDURE

Laceration repaired with Dermabond

Interventions

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Dermabond and steristrips

Laceration repaired with Dermabond with underlying steristrips

Intervention Type PROCEDURE

Dermabond

Laceration repaired with Dermabond

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Erin D Munns

Fellow Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erin Munns, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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Dell Children's Hospital

Austin, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36018733 (View on PubMed)

Other Identifiers

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2018-05-0081

Identifier Type: -

Identifier Source: org_study_id

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