An interventional study of Absorbable Sutures and Steri-Strips in Laceration, sponsored by Vanderbilt University Medical Center. Terminated at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
140 studies on the registry are indexed under Lacerations; 30 are open to participants now.
This study's enrollment of 55 is below the median of 79 across 111 interventional studies indexed under Lacerations.
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Exclusion Criteria:
Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.
Procedure: Absorbable Sutures
Patients will have their laceration closed with a special medical tape called "Steri-Strips."
Procedure: Steri-Strips
Patients will have their laceration closed with a special skin glue called "Dermabond"
Procedure: Dermabond
The patient's doctor will close the patient's laceration with absorbable sutures.
Also known as: Stitches
The patient's doctor will close the patient's laceration with Steri-Strips.
Also known as: Medical tape
The patient's doctor will close the patient's laceration with Dermabond.
Also known as: Skin glue
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"
Time frame: 3 months
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."
Time frame: 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
Time frame: 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"
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 3 months
| Milestone | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Started | 20 | 17 | 18 |
| Completed | 12 | 11 | 7 |
| Not completed | 8 | 6 | 11 |
| Withdrew: Lost to follow-up | 8 | 6 | 11 |
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"
| units on a visual analog scale | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Cosmetic Outcome of Scar at 3 Months | 64.00 (51.00 to 76.00) | 54.00 (35.50 to 66.75) | 48.50 (29.50 to 78.75) |
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."
| units on a scale | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Pain Experienced by Patient as Reported by Parent | 17.00 (1.50 to 51.50) | 22.00 (9.00 to 28.00) | 11.00 (3.00 to 24.50) |
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
| units on a scale | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Satisfaction With Time in the Emergency Department | 89.50 (45.25 to 98.50) | 92.00 (83.00 to 100.00) | 94.00 (71.25 to 100.00) |
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"
| units on a scale | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Likelihood That Parent Would Recommend Laceration Closure Method | 99.50 (88.00 to 100.00) | 99.00 (95.00 to 100.00) | 99.50 (94.50 to 100.00) |
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.
| complications | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Number of Complications of the Wound Site | 0 | 0 | 0 |
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".
| units on a scale | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Parental Reported Satisfaction With the Cosmetic Appearance of the Scar | 70.50 (59.75 to 76.75) | 67.00 (55.00 to 78.00) | 85.00 (73.00 to 90.00) |
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".
| scars with train tracks | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Presence of Train Tracks at the Scar Site | 4 | 4 | 3 |
Collected over Baseline to 3 months post-procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Absorbable Sutures | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Steri-Strips | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Dermabond | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| Median | 3.50 (2.75 to 5.00) | 3.00 (2.00 to 5.00) | 4.00 (3.00 to 5.00) | 3.00 (2.75 to 5.00) |
| Sex: Female, Male(Participants) | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| Female | 3 | 5 | 4 | 12 |
| Male | 17 | 12 | 14 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 1 | 3 |
| Not Hispanic or Latino | 18 | 16 | 16 | 50 |
| Unknown or Not Reported | 0 | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 4 | 12 |
| White | 14 | 12 | 10 | 36 |
| More than one race | 1 | 1 | 3 | 5 |
| Unknown or Not Reported | 0 | 1 | 1 | 2 |
| Laceration Length (cm)(cm) | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| Median | 1.50 (1.19 to 2.00) | 1.00 (1.00 to 1.50) | 1.50 (1.00 to 2.00) | 1.50 (1.00 to 1.94) |
| Laceration Width (cm)(cm) | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| Median | 0.50 (0.30 to 0.50) | 0.50 (0.30 to 0.50) | 0.50 (0.50 to 0.50) | 0.50 (0.30 to 0.50) |
| Training Level of Proceduralist(Participants) | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| Resident | 7 | 11 | 10 | 28 |
| Fellow | 4 | 2 | 1 | 7 |
| Nurse Practitioner | 6 | 3 | 4 | 13 |
| Attending | 3 | 1 | 3 | 7 |
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