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 Healing Ointment Usage Post-surgical Procedure (NCT05686928), a na phase 4 study. The primary outcome is Objective Erythema Assessment Using Clinical Grading Analog Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05686928 |
| Phase | Phase 4 |
| Condition | Surgical Wound |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with a surgical wound after a dermatologic procedure. The registry record lists an enrollment of 15 and says the primary outcome population was based on the Intent-to-Treat population. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The intervention was Cetaphil Healing Ointment, described as a petrolatum-based opaque ointment applied to the surgical wound twice daily. The study aimed to evaluate skin improvement after dermatologic procedures. The registry record does not report additional details about how application was monitored or whether adherence was measured.
Comparator
There was no comparator group in the registry record. The study is listed as a single-group study, with allocation marked NA and masking listed as none. The ointment group therefore cannot be interpreted as one arm of a randomized comparison against a control group.
Primary question
The primary outcome was an objective clinical grading of erythema at the surgical area, with lower scores indicating a better outcome. The registry describes change in tolerability from baseline to day 28 after daily ointment use, with assessments immediately after the procedure and on day 7/14 and day 28. The actual outcome values are not reported in the registry record.
In statistical terms, the registry poses a within-group descriptive question: how erythema scores were assessed over time among participants using the ointment. Without a concurrent comparison group, changes over time cannot isolate the ointment’s contribution from other influences, such as the natural course of wound healing or differences in procedures and participants. The registry record does not report a treatment-effect estimate against a control condition.
3. Trial Design
The registry identifies this study as a multi-center, prospective pilot study and lists it as phase 4. It is marked completed, with a start date of 2022-08-17 and a primary completion date of 2022-10-31. The listed enrollment is 15. The condition is surgical wound, and the brief summary describes evaluating benefits of a healing ointment for skin improvement after dermatologic procedures.
The design is single-group, with allocation marked NA and masking listed as none. The intervention is Cetaphil Healing Ointment. Its description specifies a petrolatum-based opaque ointment applied to the surgical wound twice daily. These design details mean the study follows an ointment group without a listed randomized or concurrent control group. It is not a like-for-like controlled comparison, and the posted information should be read as describing that group rather than a contrast between treatments.
The primary outcome is a clinical erythema grade collected at several stated time points: immediately post-procedure on the same day, day 7/14, and day 28 from baseline. The endpoint description identifies a scale from 0 to 3 and says lower scores reflect a better outcome. The primary outcome population is described as based on Intent-to-Treat. The registry record does not report additional detail about how that population was operationalized, how many participants contributed data at each time point, or how measurements were handled if they were unavailable.
The study title and description identify it as a pilot, but a sample-size justification and further protocol details are not reported in the registry record. The record lists 9 outcome measures and 0 analyses. It also lists the same subject-satisfaction self-assessment outcome twice among the secondary outcomes. No posted primary outcome summary values are reported in the registry record, so the design can be described but the observed trajectory cannot be assessed from the registry information.
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.
Before assignment: 15 subjects met the inclusion and exclusion criteria, and were enrolled in the study.
Overall Study
| Stage | Healing Ointment |
|---|---|
| STARTED | 15 |
| COMPLETED | 12 |
| NOT COMPLETED | 3 |
Analysis population for the primary outcome, as defined in the registry: Analysis population was based on Intent-to-Treat population.
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 | Healing Ointment |
|---|---|---|
| Participants analysed | 15 | |
| Age, Continuous | years | 56.3 (SD 21.85) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 7 |
| Race/Ethnicity, Customized: Race/Ethnicity – Caucasian Non-Hispanic | Participants | 10 |
| Race/Ethnicity, Customized: Race/Ethnicity – Hispanic | Participants | 5 |
| Region of Enrollment: United States | participants | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Erythema Assessment Using Clinical Grading Analog Scale, measured over Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is an objective clinical grading of erythema at the surgical area after use of the healing ointment. Erythema means redness, and the registry describes a clinical scale from 0 to 3: 0 is none, 1 is mild, 2 is moderate, and 3 is severe. Lower scores indicate a better outcome. The registry identifies the endpoint as continuous for summary purposes and specifies a mean with standard deviation.
The stated assessment schedule is immediately after the procedure on the same day, day 7/14, and day 28 from baseline. The endpoint description refers to change in tolerability from baseline to day 28. The listed schedule can track how the clinical grade varies across those visits, while the day 28 change describes the stated end-of-follow-up focus. The registry record does not report the score summaries or the change values.
Clinical grading provides a structured way to describe erythema rather than relying only on an unstructured impression. A scale can make observations more consistent, but it remains important to know how grading was conducted and whether assessors were masked. Masking is listed as none; other grading procedures are not reported in the registry record. Because the grade uses ordered categories, a mean can be a compact summary, but it does not show the full pattern of grades or how many participants were in each category. The scale’s purpose and summaries do not, by themselves, establish that any change was caused by the ointment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a prospective, single-group study of a healing ointment and identifies clinical erythema grading as the primary outcome. It gives the assessment schedule and says the scale ranges from 0 to 3, with lower scores reflecting a better outcome. However, the primary outcome values are not reported in the registry record. There is therefore no posted mean, standard deviation, change estimate, or time-specific score to interpret. The direction or size of any observed change cannot be determined from the registry information.
The single-group design is central to interpreting this study. Repeated assessments can describe what happened within the group over time, but they do not establish what would have happened over the same period without the ointment. Wound healing can change with time, and procedural or participant characteristics can also affect erythema. Without a concurrent comparator, such influences cannot be separated from an ointment-associated change. The record itself flags that this is not a randomized comparison and that the arms are not a like-for-like control comparison.
The registry specifies a mean and standard deviation for a scale with ordered grades. A mean can describe the group’s average score, while the standard deviation describes variation in scores around that average. Neither summary alone shows whether scores were concentrated in one grade or spread across categories. The actual summaries are not reported in the registry record, so even these descriptive features cannot be assessed. Confidence intervals and inferential tests are also not reported in the registry record; precision and statistical evidence for change therefore cannot be evaluated from the posted information.
The listed population is based on Intent-to-Treat, but the record does not provide the number of observations contributing to each assessment or explain how missing assessments were handled. This matters for a repeated-measure outcome: if data availability differs over time, later summaries may reflect a different observed subset. The registry record does not give enough information to assess that possibility.
The adverse-event listing reports 0 serious adverse events, 0 other adverse events, and 0 deaths, with 15 at risk for each adverse-event category. These are the posted counts for the listed group. They are descriptive safety counts, not proof that an event is impossible or that safety is established for other settings or populations. The study’s pilot, single-group design and the absence of detailed outcome results limit what can be inferred about both effectiveness and safety.
9. Statistical Methods Explained
The statistical information in the registry record is limited. It identifies the primary measure as continuous, specifies a mean and standard deviation, gives an assessment schedule, and describes the analysis population as Intent-to-Treat. It does not report a detailed statistical analysis plan, a model for repeated measurements, a missing-data approach, confidence intervals, or inferential test results. The explanations below describe general statistical concepts and should not be read as claims about analyses that were conducted.
What does a mean describe?
For a continuous summary, the mean is the arithmetic average of the observed scores. In this study, the underlying clinical grade is an ordered scale from 0 to 3. Summarizing ordered grades with a mean can give a concise account of the group’s central score, but it can conceal the distribution across grades. For example, a group average does not reveal whether observations clustered in one category or were spread across several categories. The registry record does not provide the score distribution or the mean values.
The standard deviation describes how dispersed individual observations are around the mean. It is a measure of variation among observations, not a measure of how precisely the mean has been estimated. A small standard deviation indicates that observations are relatively close to the mean; a larger one indicates more spread. Since no standard deviations are reported in the registry record, the variability of the erythema grades cannot be assessed.
What would a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity, such as a mean or change. A narrower interval indicates greater precision under the assumptions of the method used; a wider interval indicates more uncertainty. A confidence interval does not fix design limitations. In a single-group study, an interval around a within-group change would not, on its own, estimate the difference between ointment use and a comparator. No confidence interval for the primary outcome is reported in the registry record.
How should repeated assessments be understood?
The registry lists assessments immediately after the procedure, on day 7/14, and on day 28. Repeated measures allow observations at different times to be described, but measurements from the same participant are generally related rather than independent. General statistical methods for repeated data account for that relationship when estimating change or comparing time points. The registry record does not report whether such a method was used, or specify a model, covariance structure, or adjustment for baseline values. It is therefore not possible to identify the analysis approach from the posted record.
The endpoint description refers to change from baseline to day 28, while the time frame also names intermediate assessments. A change score compares a later value with a baseline value; interpretation depends on a clear definition of baseline and on the availability of paired observations. The registry record does not report the numerical baseline or follow-up summaries, the calculation details, or how incomplete pairs were handled.
Why does the single-group design matter?
A within-group change can be a useful descriptive quantity, but it is not equivalent to a controlled treatment effect. Without a comparator, the observed course may reflect time, the procedure, participant characteristics, co-occurring care, or other influences as well as ointment use. Random allocation and masking are not listed: allocation is NA, masking is none, and the study model is single group. The registry record does not report an adjusted comparison or a method that could remove these design limitations.
Masking can matter when outcomes require judgment. A clinical grade uses defined categories, but grading may still involve assessment decisions. With masking listed as none, knowledge of study participation or ointment use could potentially influence assessment. This is a general consideration, not evidence that any particular assessment was biased. Further information about assessors and grading procedures is not reported in the registry record.
What do planning sample sizes mean?
Any sample-size figures associated with this study should be understood as planning illustrations, not as observed power. The stated illustration framework uses a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation; it bases the effect to detect on a stated fraction of the observed effect. These assumptions are not a description of the actual single-group design. A hypothetical two-arm planning calculation does not create a control group, change the study allocation, or show that the study had a particular probability of detecting an effect. The registry record does not report a sample-size justification for the trial itself. No planning values should be interpreted as results or as observed power.
More generally, statistical power is a prospective design concept that depends on assumptions about the effect, variability, allocation, and analysis. A planning illustration can show how a hypothetical design might be sized under its assumptions. It cannot establish that an observed result is reliable, and it does not substitute for an estimate with its uncertainty. Because primary outcome results are not reported in the registry record, a study-specific observed effect cannot be evaluated from the posted information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 9 outcome measures and 0 analyses. The primary outcome is the objective erythema assessment. The secondary outcome list contains the subject satisfaction self-assessment questionnaire twice under the same name. The record does not explain whether the repeated listing reflects separate assessments, a duplicate entry, or a distinction not captured in the registry information.
Multiplicity arises when a study evaluates multiple outcomes, time points, or statistical comparisons. In general, considering many tests can increase the chance that at least one result appears notable by chance. Statistical plans may address this through a prespecified primary endpoint, a hierarchy of tests, or an adjustment procedure. The registry record does not report a multiplicity strategy, a testing hierarchy, or any inferential analyses. It would therefore be inappropriate to assume an adjustment was or was not applied beyond what is explicitly listed.
The primary outcome population is described as based on Intent-to-Treat. The record does not report how that population was defined in practice, how many participants contributed to each time point, or how missing observations were handled. Missing-data methods are not reported in the registry record. In general, missing follow-up measurements can affect summaries if the participants with observed data differ from those without observed data. For an outcome measured repeatedly, reporting availability by visit and explaining the handling of missing values helps readers judge whether the observed trajectory may be affected by incomplete follow-up.
The record does not report imputation, sensitivity analyses, interim analyses, or a detailed analysis plan. These should be treated as unreported rather than assumed absent from the study process. With no posted outcome summaries or analyses, readers cannot assess the role of multiplicity or missing data in any estimated result.
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 |
|---|---|---|---|
| Healing Ointment | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Healing Ointment | 0 of 15 |
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 |
|---|---|
| Healing Ointment | 0 of 15 |
The registry lists 15 at risk for serious adverse events and reports 0 serious adverse events. It also lists 15 at risk for other adverse events and reports 0 other adverse events. The death count is 0. No serious adverse event terms are listed. These are the safety counts recorded for the Healing Ointment group; they are not a comparison with an untreated or alternative-treatment group.
A count of 0 means that no events of that category were recorded in the posted results for the listed group. It does not establish that such events cannot occur, and it does not provide a comparative estimate of risk. Safety interpretation also depends on how events were defined, collected, and followed. Further detail about those procedures is not reported in the registry record.
The listed at-risk counts describe the registry’s safety denominators. They should not be expanded into claims about people outside this study or about other uses of the ointment. The record does not provide event-level descriptions for non-serious events, and it lists no serious adverse event terms. These counts are descriptive; they do not establish general safety or replace a comparison designed to assess differences between groups.
12. What the Result Does, and Does Not, Mean
The registry record describes a prospective pilot study in which a healing ointment was applied to surgical wounds twice daily. It identifies erythema grading as the primary outcome and states that lower scores reflect a better outcome. These details clarify what the study set out to assess and how the clinical scale was interpreted. However, primary outcome values are not reported in the registry record, so no conclusion about the observed score pattern or its precision can be drawn from the posted information.
The single-group design allows the study to describe assessments over time among participants using the ointment. It does not provide a randomized, concurrent comparison that could distinguish changes associated with ointment use from changes that might occur with time or other factors. A within-group difference, if reported, would not by itself show what the outcome would have been without the ointment. The record does not report a control group or a comparative effect estimate.
The registry’s safety listing records 0 serious adverse events, 0 other adverse events, and 0 deaths. Those counts describe the posted safety results for the listed group. They should not be read as proof that adverse events cannot occur, nor as evidence of comparative safety. Further safety-collection details are not reported in the registry record.
More broadly, a pilot study can contribute descriptive information about how an outcome is assessed in a study setting. But the registry record does not report the sample-size justification, detailed statistical methods, missing-data handling, or primary outcome summaries needed to assess the observed erythema trajectory. The posted information therefore supports a description of the study’s design and measures, not an estimate of the ointment’s effect. It does not establish benefit, lack of benefit, or a treatment recommendation.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of how design determines the questions an outcome can answer. The registry identifies a prospective, multi-center pilot study with a single-group model. The primary measure is repeated clinical grading of erythema, with lower scores described as better. A schedule of assessments can characterize how a score changes over time, but a single-group trajectory is not a controlled estimate of what the ointment itself caused.
The scale also illustrates the trade-off between concise summaries and detail. A mean and standard deviation can communicate a central score and its spread, while the underlying grades are ordered categories. Category-level results could show patterns that a mean alone cannot. The registry record does not report those distributions or the mean and standard deviation values, so that distinction cannot be explored for this study’s observed data.
The record is also a reminder that interpretation depends on transparent reporting. Information about the primary outcome values, uncertainty, analysis methods, missing observations, and assessment procedures would help readers understand the evidence. The registry record does not report those details. The absence of posted results limits interpretation independently of the study’s design.
Finally, the listed sample-size framework is a planning illustration based on hypothetical two-arm assumptions, whereas the actual study is single group. Keeping planning calculations separate from observed findings prevents a hypothetical design calculation from being mistaken for trial power or evidence of a treatment effect. This distinction is important when communicating results from pilot studies and registry records.
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 main limitation for interpreting this specific study is that the registry record does not report the primary outcome values. Without the mean, standard deviation, change estimate, or visit-specific scores, the erythema trajectory and its precision cannot be assessed. The record also lists 0 analyses, so there are no posted analysis results to interpret.
The single-group design has no concurrent comparator. Consequently, even if within-group changes were available, they could not separate ointment-associated change from natural change over time, effects of the dermatologic procedure, or other influences. Allocation is marked NA and masking is listed as none. The registry record does not describe additional safeguards against assessment or other sources of bias.
The endpoint is summarized as a mean and standard deviation despite being based on an ordered clinical scale. That summary can be useful, but it does not reveal the distribution across the scale’s grades. No category-level results are reported in the registry record. Further details about assessor training, grading consistency, or how erythema was assessed are also not reported.
The record describes the primary outcome population as based on Intent-to-Treat, but does not report the number of observations available at each visit or how missing data were handled. A sample-size justification, detailed statistical analysis plan, confidence intervals, and multiplicity approach are not reported in the registry record. The listed secondary satisfaction outcome is repeated under the same name, without an explanation of the duplication. These reporting gaps restrict assessment of the analysis and of the uncertainty around any result.
The safety listing contains zero events in its reported categories, but details about event collection, definitions, and follow-up are not reported. The pilot designation and enrollment of 15 are part of the record; the record does not provide a basis for treating the findings as broadly representative. These design and reporting limitations should be kept in view when interpreting the study’s scope.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Healing Ointment Usage Post-surgical Procedure — NCT05686928.
- Registry record last updated 2025-05-22; status last verified 2025-05.
- Results first posted 2025-05-22.
- 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 identifies NCT05686928 as a completed, phase 4, multi-center, prospective pilot study titled “Healing Ointment Usage Post-surgical Procedure.” It lists Galderma R&D as sponsor, an enrollment of 15, and a study period beginning 2022-08-17 with primary completion on 2022-10-31.
The study is single group, with allocation marked NA and masking listed as none. The intervention is Cetaphil Healing Ointment, described as a petrolatum-based opaque ointment applied to a surgical wound twice daily. The primary outcome is objective erythema grading on a scale from 0 to 3, assessed immediately after the procedure, on day 7/14, and on day 28. Lower scores indicate a better outcome.
The registry record describes an Intent-to-Treat primary outcome population and specifies a mean and standard deviation, but does not report the primary outcome values or analyses. Safety listings report 0 serious adverse events, 0 other adverse events, and 0 deaths. A comparator group is not listed, so the record describes a single-group assessment rather than a randomized treatment comparison.