Trial Outcomes & Findings for Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches (NCT NCT03280628)
NCT ID: NCT03280628
Last Updated: 2023-07-17
Results Overview
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"
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
3 months
Results posted on
2023-07-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
18
|
|
Overall Study
COMPLETED
|
12
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
11
|
Baseline Characteristics
Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
Baseline characteristics by cohort
| Measure |
Absorbable Sutures
n=20 Participants
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.
|
Steri-Strips
n=17 Participants
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.
|
Dermabond
n=18 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.50 years
n=5 Participants
|
3.00 years
n=7 Participants
|
4.00 years
n=5 Participants
|
3.00 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Laceration Length (cm)
|
1.50 cm
n=5 Participants
|
1.00 cm
n=7 Participants
|
1.50 cm
n=5 Participants
|
1.50 cm
n=4 Participants
|
|
Laceration Width (cm)
|
0.50 cm
n=5 Participants
|
0.50 cm
n=7 Participants
|
0.50 cm
n=5 Participants
|
0.50 cm
n=4 Participants
|
|
Training Level of Proceduralist
Resident
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Training Level of Proceduralist
Fellow
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Training Level of Proceduralist
Nurse Practitioner
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Training Level of Proceduralist
Attending
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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"
Outcome measures
| Measure |
Absorbable Sutures
n=12 Participants
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.
|
Steri-Strips
n=11 Participants
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.
|
Dermabond
n=7 Participants
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.
|
|---|---|---|---|
|
Cosmetic Outcome of Scar at 3 Months
|
64.00 units on a visual analog scale
Interval 51.0 to 76.0
|
54.00 units on a visual analog scale
Interval 35.5 to 66.75
|
48.50 units on a visual analog scale
Interval 29.5 to 78.75
|
SECONDARY outcome
Timeframe: BaselineParents 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."
Outcome measures
| Measure |
Absorbable Sutures
n=20 Participants
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.
|
Steri-Strips
n=17 Participants
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.
|
Dermabond
n=18 Participants
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.
|
|---|---|---|---|
|
Pain Experienced by Patient as Reported by Parent
|
17.00 units on a scale
Interval 1.5 to 51.5
|
22.00 units on a scale
Interval 9.0 to 28.0
|
11.00 units on a scale
Interval 3.0 to 24.5
|
SECONDARY outcome
Timeframe: Baseline to wound closure, up to 30 minutesParents 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
Outcome measures
| Measure |
Absorbable Sutures
n=20 Participants
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.
|
Steri-Strips
n=17 Participants
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.
|
Dermabond
n=18 Participants
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.
|
|---|---|---|---|
|
Satisfaction With Time in the Emergency Department
|
89.50 units on a scale
Interval 45.25 to 98.5
|
92.00 units on a scale
Interval 83.0 to 100.0
|
94.00 units on a scale
Interval 71.25 to 100.0
|
SECONDARY outcome
Timeframe: Post-wound closure, approximately 30 minutesParents 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"
Outcome measures
| Measure |
Absorbable Sutures
n=20 Participants
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.
|
Steri-Strips
n=17 Participants
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.
|
Dermabond
n=18 Participants
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.
|
|---|---|---|---|
|
Likelihood That Parent Would Recommend Laceration Closure Method
|
99.50 units on a scale
Interval 88.0 to 100.0
|
99.00 units on a scale
Interval 95.0 to 100.0
|
99.50 units on a scale
Interval 94.5 to 100.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 55 subject were enrolled but only 30 completed 3 month follow-up. This outcome measure was collected at 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.
Outcome measures
| Measure |
Absorbable Sutures
n=12 Participants
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.
|
Steri-Strips
n=11 Participants
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.
|
Dermabond
n=7 Participants
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.
|
|---|---|---|---|
|
Number of Complications of the Wound Site
|
0 complications
|
0 complications
|
0 complications
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only 30 parents/subjects provided 3 month follow-up photos of their 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".
Outcome measures
| Measure |
Absorbable Sutures
n=12 Participants
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.
|
Steri-Strips
n=11 Participants
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.
|
Dermabond
n=7 Participants
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.
|
|---|---|---|---|
|
Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
|
70.50 units on a scale
Interval 59.75 to 76.75
|
67.00 units on a scale
Interval 55.0 to 78.0
|
85.00 units on a scale
Interval 73.0 to 90.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 55 subjects were enrolled but only 30 subjects submitted scar photos 3 months after closure.
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".
Outcome measures
| Measure |
Absorbable Sutures
n=12 Participants
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.
|
Steri-Strips
n=11 Participants
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.
|
Dermabond
n=7 Participants
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.
|
|---|---|---|---|
|
Presence of Train Tracks at the Scar Site
|
4 scars with train tracks
|
4 scars with train tracks
|
3 scars with train tracks
|
Adverse Events
Absorbable Sutures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Steri-Strips
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dermabond
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place