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

Facial Laceration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685565
• Other study ID #: 2018-05-0081
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Laceration
• Facies
• Lacerations

Intervention

Procedure:
• Dermabond and steristrips
Laceration repaired with Dermabond with underlying steristrips
• Dermabond
Laceration repaired with Dermabond

Locations

Country	Name	City	State
United States	Dell Children's Hospital	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to repair laceration	A stopwatch will be used to time how long it takes the physician to repair the wound	Day 0 (physician will complete just after the repair)
Secondary	Ease of repair of laceration	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.	Day 0 (physician will complete just after the repair)
Secondary	Type of analgesia & sedation required	Physician will write down what types of analgesia they used and whether or not sedation was used after the repair is complete	Day 0 (physician will complete just after the repair)
Secondary	Wound dehiscence	Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.	1 week
Secondary	Wound infection	Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.	1 week