Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects (NCT03470012), a na na study. The primary outcome is The Face, Legs, Activity, Cry, Consolability (FLACC) Score..

2. Clinical Question

The objective is framed as an assessment of relative gentleness, but the listed design does not include a second tape as a concurrent comparator. As a result, the question addressed by the recorded endpoint is narrower: what change in FLACC score was observed from the with-tape baseline to the post-removal assessment in this group? A before-and-after measurement can describe change over that interval, but by itself it does not establish how that change compares with another tape or with no tape removal.

The registry identifies the study as completed, with start on 2018-01-16 and primary completion on 2018-01-23. It lists enrollment of 24. The outcome description gives the measurement timing and the score scale, but the result itself is not reported in the registry record. Therefore, the clinical question can be described from the registered objective and endpoint, while the observed answer cannot be quantified from the record.

3. Trial Design

The registry describes a completed, single-group device study sponsored by Solventum US LLC. It lists the intervention as Multi-Purpose Gentle Tape and describes the Treatment Arm as investigational tape. The listed enrollment is 24, and the record gives a study start date of 2018-01-16 and a primary completion date of 2018-01-23. The study is marked as having no phase, allocation, or masking classification beyond the entries NA and NONE, respectively.

These design details matter for interpretation. A single-group before-and-after assessment differs from a randomized comparison: each participant’s baseline measurement is used as a reference for the later measurement, but there is no concurrently randomized control group in the registry. The baseline is described as a FLACC score with tape still in place; the follow-up score was recorded after removal at the 24 hour visit. Thus the endpoint expresses change across two measurement conditions and times, rather than a contrast between assigned treatment groups.

The registry identifies one primary outcome measure, the Face, Legs, Activity, Cry, Consolability (FLACC) score, and reports zero analyses. It does not describe a statistical analysis plan, a sample-size justification, interim analyses, or an analysis population. Those omissions limit what can be said about how the study was intended to quantify uncertainty or handle data. The absence of an analysis listing is not evidence that a particular analysis was performed or not performed outside what the record states; it means the registry record does not report one.

The study’s stated objective is to determine the relative gentleness of a new medical tape. The registered setup measures score change around tape removal, but it does not identify a comparator tape. This design can characterize the recorded change in the studied group if results are available. It does not, on its own, supply a like-for-like comparison of the investigational tape with another tape. The registry’s caution that the arms are not a like-for-like control comparison is consistent with its single-group classification.

The status is COMPLETED, but completion status is not a numerical outcome. It indicates the registry’s recorded study status and does not fill in the missing primary result. The numerical mean change, its full range, and any inferential analysis are 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

Analysis population for the primary outcome, as defined in the registry: Measure change in FLACC score for 24 Participants at the time of tape removal and baseline.

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.

6. Primary Endpoint

The registry lists the primary outcome as The Face, Legs, Activity, Cry, Consolability (FLACC) Score., measured over 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline..

The primary endpoint is the change in FLACC score between a baseline measurement taken with tape still in place and a measurement taken after tape removal at the 24 hour visit. The registry defines the reported value as the score after removal minus the baseline score. The scale is described as a pain-assessment measure for children between 2 months and 7 years or for individuals unable to communicate their pain. Its range is 0-10, with 0 representing no pain; lower values represent lessening pain on the scale.

A change endpoint places the two recorded scores on a common scale and describes how the measured score differed across the specified assessments. The score with tape in place provides the participant’s own baseline reference. In general, a scale intended to assess pain can be useful when participants may not be able to communicate pain in other ways, as the registry description notes. The score is still a measurement, not a direct observation of every aspect of comfort or skin response.

The primary outcome is specified as a mean, with dispersion described as the full range. The record states that change was to be measured for 24 participants, but it does not give the numerical mean change or the endpoints of the range. Therefore, the direction, magnitude, and spread of the observed endpoint cannot be evaluated from the registry record. Nor does the endpoint alone measure a comparison with another tape, because no comparator tape is listed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is a change score: the FLACC value after tape removal minus the baseline FLACC value recorded while tape remained in place. This definition fixes the direction of subtraction. In general, the sign of a change score depends on the order of subtraction, so it is important to preserve the registry’s stated order when interpreting any result. The registry does not report a numerical change, so only the definition—not the observed direction—can be explained.

What does a mean change describe?

A mean summarizes the average of the participant-level changes included in an analysis. It can provide a compact description of the group’s change, but it does not show whether every participant changed in the same direction or by a similar amount. Different patterns of participant-level values can produce the same mean. The registry specifies a mean as the primary outcome parameter, but does not report the mean value or the participant-level data. The record also does not report how many participants contributed usable primary outcome measurements or how missing measurements were handled.

The endpoint’s scale is described as running from 0-10, with 0 representing no pain and lower values representing lessening pain. A change score uses the scale’s units to describe movement between assessments. In general, interpretation should account for both the scale’s meaning and the subtraction order. A numerical change cannot be interpreted for this study because the value is not reported in the registry record. It would also be inappropriate to infer that a score change necessarily captures every relevant aspect of tape gentleness.

Why report a range?

The registry specifies the full range as the dispersion measure. A range describes the lowest and highest values observed, and therefore indicates the span of observed results. In general, it is sensitive to extreme observations and does not reveal how values are distributed between the endpoints. It is not equivalent to a confidence interval: a range describes observed data, whereas a confidence interval is an inferential summary of uncertainty around an estimate. The record gives no range values and no confidence interval.

Other ways to express variability or precision could include a standard deviation, standard error, or confidence interval, but the registry record does not report these for the primary endpoint. Their absence should not be filled by an assumption based on the stated mean and range format. Without a numerical estimate and its variability, readers cannot judge how tightly or loosely the observed group result is characterized.

What does a single-group design permit?

In a single-group before-and-after design, participants have a measurement at baseline and another after the intervention-related event. The difference can describe within-group change across those assessments. In general, a before-and-after comparison does not have the same interpretation as a randomized comparison, because there is no concurrent group assigned to a different treatment condition. Changes over time, measurement circumstances, or other factors may also influence the observed difference. This is a general design limitation, not evidence that any particular influence occurred in this study.

The registry marks allocation as NA, masking as NONE, and the model as SINGLE GROUP. It also identifies the investigational tape without a listed comparator tape. Those entries support describing the study as nonrandomized and single-group, not as a controlled comparison. The score recorded with tape still in place is the baseline reference for calculating the change; it does not create an independent control arm.

How should the planning assumptions be read?

The registry’s planning assumptions describe an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect to detect is a stated fraction of the observed effect. In general, a planning calculation asks what sample size might be needed under specified assumptions. It is not a report of what the study observed, and it does not show that the original study was designed using those assumptions.

The planning illustration is explicitly separate from the trial’s own design. The actual registry design is single-group, whereas the illustration assumes equal allocation between two arms. The record does not report a sample-size justification for the study, its intended power, or its statistical plan. The planning assumptions must not be treated as an observed-power calculation. No numerical planning estimates are described in the registry information available for this analysis, and the observed primary effect needed as the planning reference is not reported there.

In general, a significance level sets a decision threshold for a specified statistical test, while power is a planning concept related to the chance of detecting a prespecified effect under assumed conditions. Neither concept supplies evidence about the actual result. A planning illustration based on a hypothetical fraction of an observed effect also depends on the effect estimate used as its reference. Because the registry does not report that observed endpoint estimate, the assumptions alone cannot be used to infer a study result, confidence interval, or test outcome.

What inferential results are available?

The registry lists zero analyses and does not report a p-value, confidence interval, standard error, or test statistic for the primary outcome. Thus, there is no inferential result to interpret. In general, a p-value is not a measure of effect size, and a confidence interval is useful for understanding the range of values compatible with an analysis under its assumptions. Neither can be reconstructed from the endpoint definition alone. The absence of a reported analysis also means the model, covariate adjustment, and any assumptions used for inference are not reported in the registry record.

Over-dispersion is a general concern when data vary more than a model assumes; when relevant, it can make uncertainty estimates too small if ignored. The registry does not report a model for the primary endpoint or information establishing whether over-dispersion applies. It would therefore be speculative to say that a particular distributional issue affected this analysis. More generally, methods should be matched to the outcome’s scale and the study design, but the analysis details needed to assess that match are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies one primary outcome measure: change in FLACC score between the measurement with tape in place and the measurement after removal. It does not list an analysis for that outcome. A multiplicity adjustment is a method for addressing the increased chance of false-positive findings when several outcomes or comparisons are tested. Since the record lists one primary outcome measure and zero analyses, it does not provide a testing strategy or an adjustment method to assess. The record does not report whether other outcomes or exploratory analyses were conducted outside the registry listing.

Missing-data handling is not reported in the registry record. The study description says the change was to be measured for 24 participants, while the enrollment is listed as 24. Those statements do not establish that all enrolled participants had complete measurements at both assessments or were included in an analysis. There is no reported account of missing scores, exclusions, imputation, or sensitivity analyses. These details affect how a mean change should be understood, but cannot be inferred from enrollment alone.

The analysis population is also not reported in the registry record. The record does not specify whether analyses were based on all enrolled participants, participants with both measurements, or another defined population. It also does not report a statistical analysis plan or decision rules for handling protocol deviations. Consequently, the estimand—the precise group and treatment condition the analysis is intended to describe—cannot be fully reconstructed beyond the registered endpoint definition.

These omissions do not prove that missing data, additional outcomes, or analysis decisions were present. They indicate that the registry record does not document them. Without an analysis population, missing-data approach, and reported endpoint result, readers cannot assess the effect of exclusions or incomplete observations on the primary estimate.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists 24 participants at risk for serious adverse events and 24 at risk for other adverse events in the Treatment Arm. It reports zero serious adverse events, zero other adverse events, and zero deaths for that group. No serious adverse-event terms are listed. These figures describe what is recorded for the group in the registry; they do not provide a comparison with another treatment group.

A reported count of zero means that no events in that category are listed in the record. It does not establish that an event could never occur, nor does it quantify the uncertainty around an event rate. In general, safety observations from a study group are interpreted in light of the number of participants observed, the duration and completeness of follow-up, and how events were collected and classified. The registry does not provide detail on those safety methods or on follow-up completeness beyond the listed adverse-event fields.

The primary endpoint concerns FLACC score change, while the adverse-event entries are separate safety information. The zero counts do not substitute for the missing primary outcome result, and the outcome definition does not determine the safety findings. The registry’s entries can be reported as recorded, without extending them to a claim about risk outside this study.

12. What the Result Does, and Does Not, Mean

The registry establishes that a completed, single-group study evaluated Multi-Purpose Gentle Tape in healthy infant subjects and specified a FLACC score change around tape removal as its primary endpoint. The endpoint compares a baseline score with the tape in place to a score after removal at the 24 hour visit. These details clarify what the study set out to measure and how the change was defined.

The registry does not report the numerical mean change or full range. Without those values, it is not possible to describe the observed direction, size, or variability of the primary result. The record also lists zero analyses and gives no confidence interval, p-value, or other inferential result. It therefore does not support a conclusion about statistical significance or precision. Completion status and enrollment do not replace an outcome estimate.

The single-group design also defines what the endpoint can address. A baseline-to-follow-up change can describe how the recorded score differed between assessments in the study group. It is not a randomized comparison with another tape, because no concurrent comparator group is listed. The study’s stated objective uses the language of relative gentleness, but the registered setup does not provide a like-for-like comparator for estimating a relative effect.

The safety record lists zero serious adverse events, zero other adverse events, and zero deaths in the Treatment Arm, with 24 participants at risk for each adverse-event category. These are registry entries for this study group and should not be interpreted as proof that risks are absent in other settings or populations. The record does not provide additional safety-method details needed to broaden that interpretation.

In short, the registry supports a description of the study’s population, intervention, design, endpoint definition, and recorded safety counts. It does not supply the primary outcome value needed to judge what change was observed. It also does not establish comparative gentleness, a causal effect relative to another tape, or a statistical conclusion about the endpoint.

13. Why This Trial Matters Statistically

This study is statistically instructive because its objective and design need to be read together. The objective is to determine the relative gentleness of a new tape, while the registry describes a single-group measurement around tape removal and does not list a comparator tape. The score change can be framed as a within-group description, but a relative claim requires a meaningful comparison. This distinction prevents an endpoint’s wording from being mistaken for a design feature that is not present.

The record also illustrates why outcome definitions and outcome results are separate. It specifies the FLACC scale, the baseline condition, the post-removal assessment, the subtraction order, and the intended summary as a mean with full range. Those details allow readers to understand what was to be measured. They do not reveal the observed change. Because the registry record does not report the numerical result, interpretation must stop short of describing the outcome’s direction or magnitude.

Planning calculations also require careful separation from observed evidence. The planning assumptions describe a two-arm illustration even though the actual study is listed as single-group. The assumptions are not a report of the trial’s own design or an observed-power result. More generally, planning estimates depend on assumptions about the effect and analysis; they cannot repair missing outcome reporting or create a comparator where none was registered.

Finally, the safety entries show how zero event counts should be reported without overinterpretation. The registry records no serious or other adverse events and no deaths in the group, but those entries remain bounded by the study’s recorded population and reporting. Clear statistical interpretation states what the record documents, distinguishes it from what cannot be determined, and avoids turning an absent estimate into a favorable or unfavorable conclusion.

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 limitation for interpreting the result is that the registry record does not report the numerical FLACC change, even though it defines the endpoint and specifies a mean with full-range dispersion. Without the estimate and range, the observed direction, magnitude, and variability are unknown from the record. The registry also lists zero analyses and does not report a confidence interval, p-value, or other inferential result.

The study is identified as single-group, with allocation listed as NA and masking as NONE. No comparator tape is listed. A change from baseline can describe the measurements in this group, but the design does not provide a concurrent like-for-like control comparison. The baseline score is taken with tape still in place; it is not equivalent to random assignment to a control condition. This limits what can be concluded about relative gentleness or attribution of any change.

The registry does not report an analysis population, missing-data method, exclusions, or completeness of paired measurements. Enrollment of 24 and the endpoint description do not establish that each participant contributed both scores to an analysis. The record also does not state whether adjustments, additional outcomes, or sensitivity analyses were planned or performed.

Participant characteristics beyond the description of healthy infant subjects are not reported in the registry record. The record does not provide detailed eligibility criteria or a distribution of ages. The FLACC scale’s stated intended use does not establish the exact characteristics of those enrolled. Safety entries are limited to the listed event counts; additional event-collection and follow-up details are not reported. These limitations constrain generalization and detailed evaluation of both the primary endpoint and the safety record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects — NCT03470012.
• Registry record last updated 2024-10-02; status last verified 2024-09.
• Results first posted 2020-07-20.
• 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.

18. Record Summary

NCT03470012 is a completed, single-group device study sponsored by Solventum US LLC. It evaluated Multi-Purpose Gentle Tape in healthy infant subjects, with enrollment listed as 24. The study started on 2018-01-16 and reached primary completion on 2018-01-23.

The primary outcome was mean change in FLACC score between baseline with tape in place and the score after tape removal at the 24 hour visit; dispersion was specified as the full range. The registry record does not report the numerical outcome or an analysis. It lists zero serious adverse events, zero other adverse events, and zero deaths in the Treatment Arm. No comparator group is listed, so the registered design does not provide a randomized, like-for-like comparison.