Back to resultsFacial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients
Primary Purpose
Facial Laceration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dermabond and steristrips
Dermabond
Sponsored by
About this trial
This is an interventional treatment trial for Facial Laceration focused on measuring facial laceration, pediatric, dermabond, skin glue, steristrips, skin adhesive, scar, cosmesis
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
Sites / Locations
- Dell Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dermabond with underlying steristrips
Dermabond
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to repair laceration
A stopwatch will be used to time how long it takes the physician to repair the wound
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.
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
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.
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.
Full Information
NCT ID
NCT03685565
First Posted
September 17, 2018
Last Updated
January 31, 2020
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT03685565
Brief Title
Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients
Official Title
Cosmetic Outcomes of Simple Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Laceration
Keywords
facial laceration, pediatric, dermabond, skin glue, steristrips, skin adhesive, scar, cosmesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dermabond with underlying steristrips
Arm Type
Experimental
Arm Title
Dermabond
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Dermabond and steristrips
Intervention Description
Laceration repaired with Dermabond with underlying steristrips
Intervention Type
Procedure
Intervention Name(s)
Dermabond
Intervention Description
Laceration repaired with Dermabond
Primary Outcome Measure Information:
Title
Cosmesis
Description
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.
Time Frame
2 months after repair
Secondary Outcome Measure Information:
Title
Time to repair laceration
Description
A stopwatch will be used to time how long it takes the physician to repair the wound
Time Frame
Day 0 (physician will complete just after the repair)
Title
Ease of repair of laceration
Description
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 Frame
Day 0 (physician will complete just after the repair)
Title
Type of analgesia & sedation required
Description
Physician will write down what types of analgesia they used and whether or not sedation was used after the repair is complete
Time Frame
Day 0 (physician will complete just after the repair)
Title
Wound dehiscence
Description
Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.
Time Frame
1 week
Title
Wound infection
Description
Families will get a phone call at 1 week to discuss if this has occurred. The electronic medical record will also be reviewed.
Time Frame
1 week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Munns, MD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dell Children's Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36018733
Citation
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.
Results Reference
derived
Learn more about this trial
Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients
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