LacerationNCT03280628
Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
A study testing Absorbable Sutures, Steri-Strips and Dermabond in people with Laceration, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
There are several methods of closing a skin cut: stitches, skin glue, and medical tape. Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s) and medical tape (invented in the 1960s) are two newer methods to close skin cuts. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Laceration
- What is being tested?
- Absorbable Sutures, Steri-Strips and Dermabond
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2017to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Medical complaint of laceration
- Single, linear laceration
- Laceration less than 5 cm in length and 0.5 cm in width
- Laceration less than 12 hours old
- Laceration minimally contaminated (no visible dirt in wound)
- Parents and child speak English
Who cannot join
- Significant medical history that may impact wound healing (hematologic or oncologic diagnosis requiring chemotherapy, ichthyosis, epidermolysis bullosa, etc.)
- Use of oral steroids (more than 5 days in the past month)
- History of keloid formation
- Allergy to skin glue, medical tape, or topical anesthetics
- Lacerations requiring deep sutures
- Lacerations caused by animal bites or scratches
- Lacerations located on the scalp, eyebrow, eyelid, lip, mucosa, joint or nail bed
- No access to photographic capabilities (camera or smartphone) and/or e-mail, OR unable to return to the Vanderbilt Children's Hospital Emergency Room to have a picture taken at 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Children's Hospital
Nashville, Tennessee, 37212
About this study
Official title: A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures
There are several methods of closing a skin cut: stitches, skin glue, and medical tape. Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s) and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The purpose of this study is to find out which method (stitches, skin glue, or medical tape) of closing skin cuts results in the least amount of scarring. Other things the investigators will be looking at are which method is the cheapest, which causes the least pain, which requires the least amount of sedation, and which method patients and parents like the best.
Read the detailed description
When a child comes in to the Emergency Room with a skin cut, if the child and their parents consent to being in the study, they will be randomly assigned to one of three groups: stitches, skin glue, or medical tape. There will be about 30 kids in each group, and thus a goal of 90 kids total in the study.
In the Emergency Room, a lidocaine ointment will be placed on the child's cut to decrease pain. The cut will be cleaned out with sterile saline. Then, depending on which method is used, the cut will be closed with either stitches, skin glue, or medical tape by their doctor. The participants will be asked to answer a short questionnaire. Finally, they will be given discharge instructions and sent home. At 3 months, the investigators will call parents for a quick questionnaire over the phone and parents will be asked to take a picture of the patient's scar and send it to the study staff.
Once all 90 pictures have been collected, two Plastic Surgeons will be asked to rate the scars in terms of how they look. The Plastic Surgeons will not know which method was used to close which cut. Once all of the scars have been rated, the averages of scars will be compared for each closure method. The investigators will also look at how much each method cost, how much extra pain medications or sedation each group used, and which method was liked best.
- Conditions
- Laceration
- Being tested
- Absorbable Sutures, Steri-Strips, Dermabond
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable SuturesProcedure or surgery
Also called Stitches
The patient's doctor will close the patient's laceration with absorbable sutures.
Steri-StripsProcedure or surgery
Also called Medical tape
The patient's doctor will close the patient's laceration with Steri-Strips.
DermabondProcedure or surgery
Also called Skin glue
The patient's doctor will close the patient's laceration with Dermabond.
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Sutures | Active comparator | Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed. Receives: Procedure: Absorbable Sutures |
| Steri-Strips | Experimental | Patients will have their laceration closed with a special medical tape called "Steri-Strips." Receives: Procedure: Steri-Strips |
| Dermabond | Experimental | Patients will have their laceration closed with a special skin glue called "Dermabond" Receives: Procedure: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Outcome of Scar at 3 Months
Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar"
Measured: 3 months
Secondary outcomes (6)
Pain Experienced by Patient as Reported by Parent
Parents will each be asked to score how much pain they felt the patient experienced using a 100 mm Visual Analogue Scale with a score of 0 corresponding to "No pain" and a score of 100 corresponding to "Terrible pain."
Measured: Baseline
Satisfaction With Time in the Emergency Department
Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with "100" meaning completely satisfied and "0" meaning not at all satisfied
Measured: Baseline to wound closure, up to 30 minutes
Likelihood That Parent Would Recommend Laceration Closure Method
Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "Extremely unlikely" and a score of 100 corresponding to "Extremely likely"
Measured: Post-wound closure, approximately 30 minutes
Number of Complications of the Wound Site
Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.). Investigators will count the number of complications reported.
Measured: 3 months
Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
Parents will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar".
Measured: 3 months
Presence of Train Tracks at the Scar Site
Plastic Surgeons will record if a scar appears to have "train tracks" (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each photo of the scar at 3 months post-closure. Surgeons will answer "yes" or "no".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start23 Sep 2017
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: The COVID-19 pandemic made prospective enrollment no longer possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LacerationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Hanson, Vanderbilt University Medical Center
- Investigators
- Holly R Hanson, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280628
- Sponsor's protocol ID
- 171108
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2017
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barton MS, Chaumet MSG, Hayes J, Hennessy C, Lindsell C, Wormer BA, Kassis SA, Ciener D, Hanson H. A Randomized Controlled Comparison of Guardian-Perceived Cosmetic Outcome of Simple Lacerations Repaired With Either Dermabond, Steri-Strips, or Absorbable Sutures. Pediatr Emerg Care. 2024 Oct 1;40(10):700-704. doi: 10.1097/PEC.0000000000003244. Epub 2024 Aug 2.
PubMed 39141836
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures
- ClinicalTrials.gov ID
- NCT03280628
- Acronym / sponsor ID
- 171108
- Conditions
- Laceration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The COVID-19 pandemic made prospective enrollment no longer possible
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are several methods of closing a skin cut: stitches, skin glue, and medical tape. Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s) and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The purpose of this study is to find out which method (stitches, skin glue, or medical tape) of closing skin cuts results in the least amount of scarring. Other things the investigators will be looking at are which method is the cheapest, which causes the least pain, which requires the least amount of sedation, and which method patients and parents like the best.
Detailed description
When a child comes in to the Emergency Room with a skin cut, if the child and their parents consent to being in the study, they will be randomly assigned to one of three groups: stitches, skin glue, or medical tape. There will be about 30 kids in each group, and thus a goal of 90 kids total in the study.
In the Emergency Room, a lidocaine ointment will be placed on the child's cut to decrease pain. The cut will be cleaned out with sterile saline. Then, depending on which method is used, the cut will be closed with either stitches, skin glue, or medical tape by their doctor. The participants will be asked to answer a short questionnaire. Finally, they will be given discharge instructions and sent home. At 3 months, the investigators will call parents for a quick questionnaire over the phone and parents will be asked to take a picture of the patient's scar and send it to the study staff.
Once all 90 pictures have been collected, two Plastic Surgeons will be asked to rate the scars in terms of how they look. The Plastic Surgeons will not know which method was used to close which cut. Once all of the scars have been rated, the averages of scars will be compared for each closure method. The investigators will also look at how much each method cost, how much extra pain medications or sedation each group used, and which method was liked best.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Absorbable Sutures | Active comparator | Procedure: Absorbable SuturesPatients will have their laceration closed with sutures that absorb on their own and do not need to be removed. |
| Steri-Strips | Experimental | Procedure: Steri-StripsPatients will have their laceration closed with a special medical tape called "Steri-Strips." |
| Dermabond | Experimental | Procedure: DermabondPatients will have their laceration closed with a special skin glue called "Dermabond" |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Medical complaint of laceration
- Single, linear laceration
- Laceration less than 5 cm in length and 0.5 cm in width
- Laceration less than 12 hours old
- Laceration minimally contaminated (no visible dirt in wound)
Key exclusion criteria (8 listed)
- Significant medical history that may impact wound healing (hematologic or oncologic diagnosis requiring chemotherapy, ichthyosis, epidermolysis bullosa, etc.)
- Use of oral steroids (more than 5 days in the past month)
- History of keloid formation
- Allergy to skin glue, medical tape, or topical anesthetics
- Lacerations requiring deep sutures
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 |
|---|---|---|
| Absorbable SuturesAlso: StitchesThe patient's doctor will close the patient's laceration with absorbable sutures. | Procedure or surgery | Absorbable Sutures |
| Steri-StripsAlso: Medical tapeThe patient's doctor will close the patient's laceration with Steri-Strips. | Procedure or surgery | Steri-Strips |
| DermabondAlso: Skin glueThe patient's doctor will close the patient's laceration with Dermabond. | Procedure or surgery | Dermabond |
Primary outcome
Cosmetic Outcome of Scar at 3 Months
Time frame: 3 months
Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar"
6 secondary outcomes
Pain Experienced by Patient as Reported by Parent
Time frame: Baseline
Satisfaction With Time in the Emergency Department
Time frame: Baseline to wound closure, up to 30 minutes
Likelihood That Parent Would Recommend Laceration Closure Method
Time frame: Post-wound closure, approximately 30 minutes
Number of Complications of the Wound Site
Time frame: 3 months
Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
Time frame: 3 months
Presence of Train Tracks at the Scar Site
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39141836Barton MS, Chaumet MSG, Hayes J, Hennessy C, Lindsell C, Wormer BA, Kassis SA, Ciener D, Hanson H. A Randomized Controlled Comparison of Guardian-Perceived Cosmetic Outcome of Simple Lacerations Repaired With Either Dermabond, Steri-Strips, or Absorbable Sutures. Pediatr Emerg Care. 2024 Oct 1;40(10):700-704. doi: 10.1097/PEC.0000000000003244. Epub 2024 Aug 2.
- 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.
Holly R Hanson, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable Sutures, Steri-Strips and Dermabond in people with Laceration, run by Vanderbilt University Medical Center 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cosmetic Outcome of Scar at 3 Months (time frame: 3 months). 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 NCT03280628, 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 17 Jul 2023.