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

Not Applicable

Completed

• Conditions: Facial Laceration
• Interventions: Procedure: Dermabond and steristrips; Procedure: Dermabond

• Registration Number: NCT03685565
• Lead Sponsor: University of Texas at Austin

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-15
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Status Verified: 2020-01
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermabond with underlying steristrips	Dermabond and steristrips	-
Dermabond	Dermabond	-

Primary Outcome Measures

Name	Time	Method
Cosmesis	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 Outcome Measures

Name	Time	Method
Ease of repair of laceration	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.
Time to repair laceration	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
Type of analgesia & sedation required	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
Wound dehiscence	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.
Wound infection	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.

Trial Locations

Locations (1)

Dell Children's Hospital; 🇺🇸 Austin, Texas, United States