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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03685565
Enrollment
120
Registered
2018-09-26
Start date
2018-09-15
Completion date
2020-01-15
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Laceration

Keywords

facial laceration, pediatric, dermabond, skin glue, steristrips, skin adhesive, scar, cosmesis

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).

Interventions

PROCEDUREDermabond and steristrips

Laceration repaired with Dermabond with underlying steristrips

PROCEDUREDermabond

Laceration repaired with Dermabond

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cosmesis2 months after repaircosmetic 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

MeasureTime frameDescription
Time to repair lacerationDay 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
Ease of repair of lacerationDay 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.
Type of analgesia & sedation requiredDay 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
Wound dehiscence1 weekFamilies will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.
Wound infection1 weekFamilies will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026