Laceration
Conditions
Brief 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. 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.
Interventions
PROCEDUREAbsorbable Sutures
The patient's doctor will close the patient's laceration with absorbable sutures.
PROCEDURESteri-Strips
The patient's doctor will close the patient's laceration with Steri-Strips.
PROCEDUREDermabond
The patient's doctor will close the patient's laceration with Dermabond.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The Plastic Surgeons who rate all scars at the end of the study are blinded to the closure method.
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome of Scar at 3 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Experienced by Patient as Reported by Parent | Baseline | 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. |
| Satisfaction With Time in the Emergency Department | Baseline to wound closure, up to 30 minutes | 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 |
| Likelihood That Parent Would Recommend Laceration Closure Method | Post-wound closure, approximately 30 minutes | 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 |
| Number of Complications of the Wound Site | 3 months | 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. |
| Parental Reported Satisfaction With the Cosmetic Appearance of the Scar | 3 months | 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. |
| Presence of Train Tracks at the Scar Site | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 17 |
| 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. | 18 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 6 | 11 |
Baseline characteristics
| Characteristic | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|
| Age, Continuous | 3.50 years | 3.00 years | 4.00 years | 3.00 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 16 Participants | 16 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Laceration Length (cm) | 1.50 cm | 1.00 cm | 1.50 cm | 1.50 cm |
| Laceration Width (cm) | 0.50 cm | 0.50 cm | 0.50 cm | 0.50 cm |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 12 Participants | 10 Participants | 36 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 14 Participants | 43 Participants |
| Training Level of Proceduralist Attending | 3 Participants | 1 Participants | 3 Participants | 7 Participants |
| Training Level of Proceduralist Fellow | 4 Participants | 2 Participants | 1 Participants | 7 Participants |
| Training Level of Proceduralist Nurse Practitioner | 6 Participants | 3 Participants | 4 Participants | 13 Participants |
| Training Level of Proceduralist Resident | 7 Participants | 11 Participants | 10 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 20 | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 17 | 0 / 18 |
Outcome results
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
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Absorbable Sutures | Cosmetic Outcome of Scar at 3 Months | 64.00 units on a visual analog scale |
| Steri-Strips | Cosmetic Outcome of Scar at 3 Months | 54.00 units on a visual analog scale |
| Dermabond | Cosmetic Outcome of Scar at 3 Months | 48.50 units on a visual analog scale |
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
Time frame: Post-wound closure, approximately 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Absorbable Sutures | Likelihood That Parent Would Recommend Laceration Closure Method | 99.50 units on a scale |
| Steri-Strips | Likelihood That Parent Would Recommend Laceration Closure Method | 99.00 units on a scale |
| Dermabond | Likelihood That Parent Would Recommend Laceration Closure Method | 99.50 units on a scale |
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.
Time frame: 3 months
Population: 55 subject were enrolled but only 30 completed 3 month follow-up. This outcome measure was collected at 3 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorbable Sutures | Number of Complications of the Wound Site | 0 complications |
| Steri-Strips | Number of Complications of the Wound Site | 0 complications |
| Dermabond | Number of Complications of the Wound Site | 0 complications |
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Absorbable Sutures | Pain Experienced by Patient as Reported by Parent | 17.00 units on a scale |
| Steri-Strips | Pain Experienced by Patient as Reported by Parent | 22.00 units on a scale |
| Dermabond | Pain Experienced by Patient as Reported by Parent | 11.00 units on a scale |
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.
Time frame: 3 months
Population: Only 30 parents/subjects provided 3 month follow-up photos of their scar
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Absorbable Sutures | Parental Reported Satisfaction With the Cosmetic Appearance of the Scar | 70.50 units on a scale |
| Steri-Strips | Parental Reported Satisfaction With the Cosmetic Appearance of the Scar | 67.00 units on a scale |
| Dermabond | Parental Reported Satisfaction With the Cosmetic Appearance of the Scar | 85.00 units on a scale |
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.
Time frame: 3 months
Population: 55 subjects were enrolled but only 30 subjects submitted scar photos 3 months after closure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorbable Sutures | Presence of Train Tracks at the Scar Site | 4 scars with train tracks |
| Steri-Strips | Presence of Train Tracks at the Scar Site | 4 scars with train tracks |
| Dermabond | Presence of Train Tracks at the Scar Site | 3 scars with train tracks |
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
Time frame: Baseline to wound closure, up to 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Absorbable Sutures | Satisfaction With Time in the Emergency Department | 89.50 units on a scale |
| Steri-Strips | Satisfaction With Time in the Emergency Department | 92.00 units on a scale |
| Dermabond | Satisfaction With Time in the Emergency Department | 94.00 units on a scale |