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The COVID-19 pandemic made prospective enrollment no longer possible
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable Sutures | Active Comparator | Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed. |
|
| Steri-Strips | Experimental | Patients will have their laceration closed with a special medical tape called "Steri-Strips." |
|
| Dermabond | Experimental | Patients will have their laceration closed with a special skin glue called "Dermabond" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Absorbable Sutures | Procedure | The patient's doctor will close the patient's laceration with absorbable sutures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline |
| Satisfaction With Time in the Emergency Department |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly R Hanson, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39141836 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Absorbable Sutures | Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed. Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures. |
| FG001 | Steri-Strips | Patients will have their laceration closed with a special medical tape called "Steri-Strips." Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips. |
| FG002 | Dermabond | Patients will have their laceration closed with a special skin glue called "Dermabond" Dermabond: The patient's doctor will close the patient's laceration with Dermabond. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Absorbable Sutures | Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed. Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures. |
| BG001 | Steri-Strips |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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" | 55 subjects were enrolled in the Emergency Department but only 30 subjects sent 3 month follow-up photos of their child's scar thus only 30 scars were reviewed by the plastic surgeons. | Posted | Median | Inter-Quartile Range | units on a visual analog scale | 3 months |
|
Baseline to 3 months post-procedure.
No difference in definition for adverse event and serious adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Absorbable Sutures | Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed. Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures. |
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Early termination of the study due to limitation regarding the COVID-19 pandemic and prospective enrollment of pediatric patients in the Emergency Department. There were also only 55% of subjects who performed 3 month follow-up thus our primary outcome can only be measured on these subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly Hanson | Vanderbilt University Medical Center | 615-936-7317 | holly.r.hanson@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2017 | Mar 24, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2019 | Mar 30, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C100832 | octyl 2-cyanoacrylate |
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The Plastic Surgeons who rate all scars at the end of the study are blinded to the closure method.
| Steri-Strips | Procedure | The patient's doctor will close the patient's laceration with Steri-Strips. |
|
|
| Dermabond | Procedure | The patient's doctor will close the patient's laceration with Dermabond. |
|
|
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 |
| 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" | 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. | 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". | 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". | 3 months |
Patients will have their laceration closed with a special medical tape called "Steri-Strips." Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips. |
| BG002 | Dermabond | Patients will have their laceration closed with a special skin glue called "Dermabond" Dermabond: The patient's doctor will close the patient's laceration with Dermabond. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Laceration Length (cm) | Median | Inter-Quartile Range | cm |
|
| Laceration Width (cm) | Median | Inter-Quartile Range | cm |
|
| Training Level of Proceduralist | Count of Participants | Participants |
|
| Steri-Strips |
Patients will have their laceration closed with a special medical tape called "Steri-Strips." Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips. |
| OG002 | Dermabond | Patients will have their laceration closed with a special skin glue called "Dermabond" Dermabond: The patient's doctor will close the patient's laceration with Dermabond. |
|
|
| Secondary | 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." | Posted | Median | Inter-Quartile Range | units on a scale | Baseline |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | units on a scale | Baseline to wound closure, up to 30 minutes |
|
|
|
| Secondary | 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" | Posted | Median | Inter-Quartile Range | units on a scale | Post-wound closure, approximately 30 minutes |
|
|
|
| Secondary | 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. | 55 subject were enrolled but only 30 completed 3 month follow-up. This outcome measure was collected at 3 months. | Posted | Number | complications | 3 months |
|
|
|
| Secondary | 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". | Only 30 parents/subjects provided 3 month follow-up photos of their scar | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
|
|
| Secondary | 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". | 55 subjects were enrolled but only 30 subjects submitted scar photos 3 months after closure. | Posted | Number | scars with train tracks | 3 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Steri-Strips | Patients will have their laceration closed with a special medical tape called "Steri-Strips." Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Dermabond | Patients will have their laceration closed with a special skin glue called "Dermabond" Dermabond: The patient's doctor will close the patient's laceration with Dermabond. | 0 | 18 | 0 | 18 | 0 | 18 |
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