This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches (NCT03280628), a randomized na study. The primary outcome is Cosmetic Outcome of Scar at 3 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03280628 |
| Phase | NA |
| Condition | Laceration |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 55 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Vanderbilt University Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Children with lacerations treated in the Emergency Department. The registry record reports that 55 subjects enrolled, but only subjects whose families submitted follow-up scar photographs could contribute to the primary cosmetic assessment.
Intervention
Closure with absorbable sutures, which absorb without removal; Steri-Strips, a medical adhesive tape; or Dermabond, a tissue adhesive.
Comparator
The three closure methods were assigned as parallel randomized groups. The posted primary results give a separate scar-rating summary for each method.
Primary question
How did blinded plastic surgeons rate the cosmetic appearance of scars at 3 months on a 0 to 100 mm visual analog scale, where 0 means “worst scar” and 100 means “best scar”?
The study was designed to compare the cosmetic outcomes of these closure approaches in children. The registry summary also describes interest in cost, pain, sedation, and the preferences of patients and parents. However, the primary endpoint is the surgeons’ assessment of scar appearance, not a combined measure of those other considerations.
The posted arm-level medians are 64.0 for absorbable sutures, 54 for Steri-Strips, and 48.5 for Dermabond. These are descriptive summaries of the scars that were rated; they do not, by themselves, establish whether differences between methods are statistically distinguishable. Comparative analysis results are not reported in the registry record.
3. Trial Design
This was a randomized, single-masked, parallel trial comparing three procedures for closing pediatric lacerations: absorbable sutures, Steri-Strips, and Dermabond. The registry record identifies Vanderbilt University Medical Center as the sponsor and lists an enrollment of 55. The trial status is terminated. The reason for termination is not reported in the registry record.
For the primary outcome, two blinded plastic surgeons rated scar appearance from follow-up photographs. The assessment took place at 3 months and used a 0 to 100 mm visual analog scale, with higher values representing a better cosmetic rating. The registry record says 55 subjects enrolled in the Emergency Department, while only 30 subjects sent photographs at the 3-month follow-up. The reported arm-level primary summaries include 12 scars in the absorbable-suture group, 11 in the Steri-Strips group, and 7 in the Dermabond group.
The registry identifies the study as randomized and single-masked, but it does not report the randomization sequence method, allocation concealment, or which participants or study personnel were masked. It does identify the plastic surgeons who rated the photographs as blinded. Further details about how the ratings from the two surgeons were combined are not reported in the registry record.
The registry summary describes other study interests, including pain, time in the Emergency Department, recommendations by parents, wound complications, parental satisfaction with scar appearance, and train-track marks. Numerical results for these secondary outcomes are not reported in the registry record. Details of the trial’s statistical plan, including any planned comparisons among the three groups, are also not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| STARTED | 20 | 17 | 18 |
| COMPLETED | 12 | 11 | 7 |
| NOT COMPLETED | 8 | 6 | 11 |
Reasons for not completing this period:
| Reason | Absorbable Sutures | Steri-Strips | Dermabond |
|---|---|---|---|
| Lost to Follow-up | 8 | 6 | 11 |
Analysis population for the primary outcome, as defined in the registry: 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.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Absorbable Sutures | Steri-Strips | Dermabond | Total |
|---|---|---|---|---|---|
| Participants analysed | 20 | 17 | 18 | 55 | |
| Age, Continuous | years | 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: Female | Participants | 3 | 5 | 4 | 12 |
| Sex: Female, Male: Male | Participants | 17 | 12 | 14 | 43 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 0 | 1 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 18 | 16 | 16 | 50 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 3 | 4 | 12 |
| Race (NIH/OMB): White | Participants | 14 | 12 | 10 | 36 |
| Race (NIH/OMB): More than one race | Participants | 1 | 1 | 3 | 5 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 | 2 |
| Laceration Length (cm) | cm | 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 | 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: Resident | Participants | 7 | 11 | 10 | 28 |
| Training Level of Proceduralist: Fellow | Participants | 4 | 2 | 1 | 7 |
| Training Level of Proceduralist: Nurse Practitioner | Participants | 6 | 3 | 4 | 13 |
| Training Level of Proceduralist: Attending | Participants | 3 | 1 | 3 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Cosmetic Outcome of Scar at 3 Months, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | units on a visual analog scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the cosmetic outcome of the scar at 3 months. Two blinded plastic surgeons rated each scar from a follow-up photograph using a 0 to 100 mm visual analog scale. The scale anchors were 0 for “worst scar” and 100 for “best scar.” Thus, higher ratings correspond to more favorable cosmetic assessments on the scale.
The registry reports the endpoint as a median with an interquartile range for each treatment group. The median describes the middle of the observed ratings and is less affected by unusually high or low values than an arithmetic mean. The interquartile range describes the central spread of ratings, from the lower to the upper quartile. It helps convey how much ratings varied among the scars that were assessed.
A clinician-rated cosmetic measure provides a structured way to compare scar appearance across closure methods. It does not capture every aspect of the experience, such as pain, cost, sedation, or parental preference. Those topics appear among the study’s other stated interests, but their numerical results are not reported in the registry record. The primary outcome also applies only to the scars with submitted follow-up photographs and ratings, rather than all 55 enrolled subjects.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results are group-level summaries of scar ratings at 3 months. The median was 64.0 for absorbable sutures, with an interquartile range from 51.0 to 76.0. For Steri-Strips, the median was 54, with an interquartile range from 35.5 to 66.75. For Dermabond, the median was 48.5, with an interquartile range from 29.5 to 78.75. On this scale, higher ratings indicate a better cosmetic assessment.
These summaries show the observed distribution of ratings among the assessed scars. The medians differ across the three groups, while the reported ranges indicate variation within each group. The ranges overlap, but overlap or lack of overlap in descriptive ranges does not by itself determine whether a formal comparison would find a statistically detectable difference. The registry record does not report comparative test results, confidence intervals for between-group effects, or a model-based estimate of the treatment contrasts. It therefore does not support a claim about statistical significance or the precision of a difference between methods.
The group sizes for the primary endpoint were 12 scars for absorbable sutures, 11 for Steri-Strips, and 7 for Dermabond. These ratings came from a subset of the enrolled subjects: the registry reports that 30 subjects sent photographs, out of 55 enrolled. The numbers contributing to the arm-level summaries are small, especially for Dermabond, so the group medians and spreads describe a limited set of observed scars. The registry does not report why some families did not submit follow-up photographs, or whether the missing photographs differed in scar appearance from those received.
Random assignment is intended to support fair comparisons between groups, but it does not remove uncertainty in results from a small set of observed outcomes or resolve potential concerns about missing follow-up. Because the trial record does not provide a reported analysis comparing the groups, the posted values should be read as descriptive rather than as evidence that one method performed better than another. The record’s terminated status does not explain why the trial ended, and the reason is not reported in the registry record.
The stated aims included outcomes beyond cosmetic ratings, such as pain, cost, sedation, and parental preferences. Those aims give context to the study question but do not supply evidence about those outcomes. Numerical findings for the listed secondary outcomes are not reported in the registry record. The posted primary results consequently address only the clinician-rated cosmetic endpoint among subjects with submitted photographs.
9. Statistical Methods Explained
The posted primary summaries use medians and interquartile ranges, which suit an endpoint recorded on a bounded visual analog scale and presented as a distribution rather than an average. The registry record identifies the endpoint parameter as the median and its dispersion as the interquartile range. It does not report a statistical comparison among the three groups, an adjusted estimate, or a confidence interval for a between-group difference.
What does the median describe?
In general, the median is the central value after observations are ordered from low to high. It is useful when the distribution may be skewed or when a small number of unusually high or low observations could influence an average. In this trial, each arm’s median summarizes the ratings for the scars represented in that arm’s primary endpoint data. The medians are 64.0 for absorbable sutures, 54 for Steri-Strips, and 48.5 for Dermabond. A median is a description of the observed group, not an estimate of the probability that one closure method is superior.
What does the interquartile range add?
In general, the interquartile range gives the interval between the lower and upper quartiles. It describes the spread of the central portion of a set of observations, rather than the full minimum-to-maximum range. The reported interval is 51.0 to 76.0 for absorbable sutures, 35.5 to 66.75 for Steri-Strips, and 29.5 to 78.75 for Dermabond. These intervals help readers see that ratings varied within each group. They are not confidence intervals for the median or for a comparison between groups.
A confidence interval, in general, describes uncertainty around an estimate under a specified statistical method. A comparative confidence interval would be useful for judging the range of differences in scar ratings compatible with the data and method. Such an interval is not reported in the registry record. The arm-level interquartile ranges cannot substitute for it because they describe within-group variation, not uncertainty around a treatment contrast.
How should the rating scale be read?
The cosmetic endpoint uses a 0 to 100 mm visual analog scale. The stated anchors give the direction: 0 corresponds to “worst scar,” and 100 corresponds to “best scar.” Therefore, higher scores indicate a more favorable rating on this scale. The endpoint is a surgeon-rated assessment of cosmetic appearance from photographs. It should not be interpreted as a direct measure of pain, healing time, cost, or parental satisfaction.
In general, ratings on a bounded scale may have distributions that are not well represented by a mean and standard deviation. The registry’s choice to report medians and interquartile ranges communicates the central location and spread without requiring an assumption that the values follow a normal distribution. The statistical plan behind this reporting choice is not reported in the registry record, so it is not possible to say whether it was prespecified or whether other summaries were planned.
What can randomization establish?
Random assignment is intended to make treatment groups comparable, on average, with respect to factors measured or not measured at baseline. That principle supports a fair comparison when assignment is carried out as planned and outcomes are adequately observed. The registry says that allocation was randomized, but the sequence generation and allocation concealment procedures are not reported in the registry record. The record also does not describe baseline characteristics by arm, so the extent of observed balance cannot be assessed from these registry entries.
The trial is described as single-masked. The identity of the masked party is not reported in the registry record. Separately, the outcome description says that two blinded plastic surgeons rated the photographs. Blinded assessment can reduce the chance that knowledge of group assignment influences ratings, but the record does not explain how blinding was maintained or whether the raters could infer the closure method from the photographs.
How do planning calculations differ from trial evidence?
In general, a sample-size calculation estimates how many participants would be needed under stated assumptions to detect a specified effect with a chosen error rate and power. The planning illustration associated with this trial is described as using the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It is a planning exercise, not an analysis of the trial’s actual design. The record does not report the trial’s own sample-size justification. A calculation based on an observed effect also does not measure the probability that the completed trial produced a true finding. It should not be described as observed power.
More generally, small samples can make estimates imprecise, and estimates based on observed effects can be especially uncertain. The arm-level medians and interquartile ranges describe the posted data, but the absence of reported comparative uncertainty means that the precision of differences among methods cannot be determined from the registry results alone. Any formal statistical analysis would also need to address the limited outcome follow-up and specify how missing photographs and multiple outcomes were handled; those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The study lists multiple outcomes in addition to the primary cosmetic assessment. These include parent-reported pain, satisfaction with time in the Emergency Department, willingness to recommend the closure method, wound complications, parental satisfaction with scar appearance, and train-track marks. The registry record also lists seven outcome measures in total. Numerical findings for the secondary outcomes are not reported in the registry record.
When a study examines several outcomes or makes multiple group comparisons, the chance of obtaining at least one apparently notable result can increase. Statistical methods sometimes address this through a prespecified hierarchy or multiplicity adjustment. The registry record does not report whether such a plan was used, whether the primary endpoint was formally prioritized for testing, or whether any adjustment was made. No comparative analysis results are reported, so multiplicity-adjusted or unadjusted p-values cannot be assessed.
Missing primary outcome data are a central limitation. The registry reports 55 subjects enrolled, but only 30 sent photographs for the 3-month scar assessment. The recorded primary endpoint summaries include 12 scars for absorbable sutures, 11 for Steri-Strips, and 7 for Dermabond. The reasons photographs were not submitted, the characteristics of subjects without ratings, and the statistical handling of missing outcomes are not reported in the registry record. No imputation method or sensitivity analysis is described.
The analysis population is also not reported in the registry record. It is therefore unclear whether the posted results follow an intention-to-treat approach, include only participants with available photographs, or use another defined population. Randomization supports comparisons based on assigned groups, but missing outcomes can weaken that protection if follow-up is related to treatment assignment or scar appearance. The available information does not establish whether that occurred.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Absorbable Sutures | 0 | 20 | 0.0% |
| Steri-Strips | 0 | 17 | 0.0% |
| Dermabond | 0 | 18 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Absorbable Sutures | 0 of 20 |
| Steri-Strips | 0 of 17 |
| Dermabond | 0 of 18 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Absorbable Sutures | 0 of 20 |
| Steri-Strips | 0 of 17 |
| Dermabond | 0 of 18 |
The registry reports serious adverse events, other adverse events, and deaths by intervention group. For absorbable sutures, 20 participants were listed at risk for serious events and 0 were affected; the same 20 were listed for other events, with 0 affected and 0 deaths. For Steri-Strips, 17 were listed at risk in each event category, with 0 serious events, 0 other events, and 0 deaths. For Dermabond, 18 were listed at risk in each category, with 0 serious events, 0 other events, and 0 deaths.
These entries mean that no events were recorded in the registry’s adverse-event figures for the listed groups. A count of zero is not proof that an event is impossible or that no event occurred outside the reporting definitions or observation period. The registry record does not report further detail about event definitions, duration of safety follow-up, or how adverse events were collected. These safety counts should be read separately from the primary cosmetic endpoint, whose arm-level group sizes differ because it includes subjects with submitted follow-up photographs.
12. What the Result Does, and Does Not, Mean
The posted data describe the cosmetic ratings assigned to scars that were assessed at the 3-month follow-up. The median ratings were 64.0 for absorbable sutures, 54 for Steri-Strips, and 48.5 for Dermabond, on a scale where higher values represent a better cosmetic rating. The interquartile ranges show that ratings varied within each group.
Those descriptive results do not establish that the methods differ in their effects. The registry record does not report a statistical comparison, a treatment-effect estimate, or uncertainty around differences between groups. Nor do the medians show how any individual child’s scar would be rated under a different closure method. They summarize the observed ratings within the trial groups.
The primary endpoint was available for a subset of enrolled subjects: 30 submitted photographs, while the registry reports 55 subjects enrolled. The arm-level counts were 12, 11, and 7. Because reasons for missing photographs and the approach to missing outcome data are not reported, the results may not represent all enrolled subjects in a way that can be evaluated from this record. The registry also does not provide numerical results for the secondary outcomes described in its study aims.
The findings therefore concern a clinician-rated cosmetic scale among submitted photographs, not the full range of practical and patient-centered outcomes raised by the study. The registry’s terminated status is recorded, but the reason for termination is not reported in the registry record. Without comparative analyses, complete outcome follow-up, and additional details about the planned analysis, the posted values are best understood as descriptive evidence from the assessed scars rather than a conclusive ranking of closure methods.
13. Why This Trial Matters Statistically
This trial illustrates a common distinction in clinical research: a randomized design and posted outcome summaries do not automatically provide a precise answer to a comparative question. The study assigned participants among three closure methods, but the primary numerical results are group-specific medians and interquartile ranges. Without a reported analysis of differences, the reader cannot determine how uncertain any apparent separation between those summaries is under a formal comparison.
The endpoint also highlights the importance of defining what is being measured. A blinded surgeon’s rating of scar appearance is a focused clinical outcome, while pain, time in the Emergency Department, parental preference, and complications represent other dimensions of care. The registry describes those additional interests, but their numerical results are not reported in the registry record. A cosmetic rating alone cannot stand in for all those outcomes.
Follow-up completeness matters to interpretation. The registry reports 55 enrolled subjects and 30 photo submissions for the primary assessment. When outcome availability is incomplete, the analysis population and reasons for missingness help determine how confidently the observed group summaries can be generalized to everyone enrolled. Those details are not reported in the registry record.
The record also demonstrates why safety counts need context. Zero recorded adverse events in the listed groups is a clear description of the posted counts, but interpretation depends on definitions, ascertainment, and follow-up information. Those details are not reported in the registry record. Together, these features make the trial statistically informative as an example of the difference between descriptive results and a fully reported comparative analysis.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary outcome is available only for subjects whose families sent follow-up photographs. The registry reports that 30 subjects submitted photographs, compared with 55 enrolled. It does not explain why photographs were missing, whether the reasons differed across treatment groups, or how missing outcomes were handled. This limits assessment of whether the rated scars represent all randomized participants.
The primary endpoint group sizes are modest: 12 for absorbable sutures, 11 for Steri-Strips, and 7 for Dermabond. The posted medians and interquartile ranges can describe those observations, but the registry does not report confidence intervals or formal comparisons. Consequently, the precision of contrasts between groups is not available from the record.
Further details about trial conduct and analysis are absent. The sequence generation method, allocation concealment, identity of the single-masked party, analysis population, and statistical plan are not reported in the registry record. The surgeons’ ratings are described as blinded, but the approach to combining ratings from the two surgeons is not reported. The record also does not describe any adjustment for multiple outcomes or comparisons.
The registry lists several secondary outcomes but does not report numerical results for them. The study status is terminated, but the reason is not reported in the registry record. These gaps prevent a fuller account of the trial’s completion, its planned analyses, and the relationship between the posted primary summaries and the broader outcomes described in the study aims.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches — NCT03280628.
- Registry record last updated 2023-07-17; status last verified 2022-09.
- Results first posted 2023-07-17.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a randomized, single-masked, parallel trial comparing absorbable sutures, Steri-Strips, and Dermabond for pediatric laceration closure. It lists 55 enrolled subjects and a terminated status; the reason for termination is not reported in the registry record.
The primary endpoint was cosmetic scar appearance at 3 months, rated by two blinded plastic surgeons on a 0 to 100 mm visual analog scale. The arm-level medians were 64.0 for absorbable sutures, 54 for Steri-Strips, and 48.5 for Dermabond. The registry reports that 30 subjects sent photographs; the primary arm summaries include 12, 11, and 7 scars, respectively.
The registry does not report comparative statistical analyses, a missing-data method, or numerical results for the listed secondary outcomes. Adverse-event figures list 0 serious events, 0 other events, and 0 deaths in each group.