Facial LacerationNCT03685565
Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients
A study testing Dermabond and steristrips and Dermabond in people with Facial Laceration, run by University of Texas at Austin at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Facial Laceration
- What is being tested?
- Dermabond and steristrips and Dermabond
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≤17 years old
- Presents with simple, linear facial laceration requiring repair
- English or Spanish speaking parents or guardians
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cosmetic Outcomes of Simple Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips: A Randomized Controlled Trial
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).
- Conditions
- Facial Laceration
- Being tested
- Dermabond and steristrips, Dermabond
- Keywords
- facial laceration, pediatric, dermabond, skin glue, steristrips, skin adhesive, scar, cosmesis
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond and steristripsProcedure or surgery
Laceration repaired with Dermabond with underlying steristrips
DermabondProcedure or surgery
Laceration repaired with Dermabond
| Study group | Role | What they receive |
|---|---|---|
| Dermabond with underlying steristrips | Experimental | Not described Receives: Procedure: Dermabond and steristrips |
| Dermabond | Active comparator | Not described Receives: Procedure: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months after repair
Secondary outcomes (5)
Time to repair laceration
A stopwatch will be used to time how long it takes the physician to repair the wound
Measured: Day 0 (physician will complete just after the repair)
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.
Measured: Day 0 (physician will complete just after the repair)
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
Measured: Day 0 (physician will complete just after the repair)
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.
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start15 Sep 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial LacerationStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin D Munns, University of Texas at Austin
- Investigators
- Erin Munns, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685565
- Sponsor's protocol ID
- 2018-05-0081
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36018733
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Outcomes of Simple Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03685565
- Acronym / sponsor ID
- 2018-05-0081
- Conditions
- Facial Laceration
- Keywords
- facial laceration, pediatric, dermabond, skin glue, steristrips, skin adhesive, scar, cosmesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone
| Arm | Type | Receives |
|---|---|---|
| Dermabond with underlying steristrips | Experimental | Procedure: Dermabond and steristrips |
| Dermabond | Active comparator | Procedure: Dermabond |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ≤17 years old
- Presents with simple, linear facial laceration requiring repair
- English or Spanish speaking parents or guardians
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermabond and steristripsLaceration repaired with Dermabond with underlying steristrips | Procedure or surgery | Dermabond with underlying steristrips |
| DermabondLaceration repaired with Dermabond | Procedure or surgery | Dermabond |
Primary outcome
Cosmesis
Time frame: 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.
5 secondary outcomes
Time to repair laceration
Time frame: Day 0 (physician will complete just after the repair)
Ease of repair of laceration
Time frame: Day 0 (physician will complete just after the repair)
Type of analgesia & sedation required
Time frame: Day 0 (physician will complete just after the repair)
Wound dehiscence
Time frame: 1 week
Wound infection
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 36018733Munns 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Munns, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermabond and steristrips and Dermabond in people with Facial Laceration, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmesis (time frame: 2 months after repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.