Prevention of Incontinence-associated Dermatitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Prevention of Incontinence-associated Dermatitis (NCT05403762), a randomized na study. The primary outcome is Incidence of Incontinence-associated Dermatitis (IAD).

2. Clinical Question

The trial addresses a practical prevention question: whether outcomes differ when one of two types of skin protectant is added to a shared cleansing regimen, compared with cleansing alone. Because the two intervention groups receive the same described cleansing approach, the planned contrast concerns the added skin-protection product as part of each regimen, not cleansing versus no cleansing.

The primary endpoint is the cumulative incidence of IAD, classified by visual inspection using the Ghent Global IAD Categorisation Tool (GLOBIAD). The record also lists secondary measures covering erythema, erosion, maceration, pain, itch, local intolerance, and adverse events. Those outcomes broaden the clinical description, but their presence in the registry does not establish what was observed or how comparisons were conducted.

The study is described as exploratory. The registry does not report a primary-outcome analysis, event counts by group, an effect estimate, or a confidence interval. The comparative question therefore remains unanswered by the results recorded in this registry entry.

3. Trial Design

This is a randomized, parallel-group, exploratory trial sponsored by Charite University, Berlin, Germany. The registry lists the allocation as randomized and masking as single. It does not identify who was masked or describe the randomization procedure, allocation concealment, or implementation details; these details are not reported in the registry record. The phase is listed as NA.

The study concerns elderly nursing-home residents and geriatric patients. The registry reports enrollment of 220. The intervention arms share a standardized mild skin-cleansing regimen administered by nursing staff, with one arm receiving daily ESENTA™ Skin Barrier Spray and the other daily Hydrophobes Basisgel DAC on exposed skin areas. The Standard Care group receives the cleansing regimen without an additional skin protectant.

The primary outcome is the incidence of IAD over 14 Days. The endpoint description uses GLOBIAD categories based on visual inspection and specifies different at-risk populations for different incidence definitions. Participants with IAD category 2 at baseline were excluded. The record states that incidence of IAD 2A/2B is based on all enrolled participants (n=167), while incidence of IAD 1 or 2 (n=143) excludes those with IAD. The registry does not explain the relationship between the enrollment figure and these outcome-specific denominators beyond those definitions.

The record lists a start date of 2022-08-19, primary completion on 2025-02-06, and status as COMPLETED. Completion status does not itself establish that results were analyzed or reported. The registry lists 10 outcome measures, including secondary outcomes, but reports 0 analyses. No analysis plan, sample-size justification for the trial itself, or primary-outcome comparison is 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.

Before assignment: 53/220 individuals were excluded before randomisation for the following reasons: * not meeting the inclusion criteria (n = 20; for example, a pre-existing wound at the investigational area), * unavailability at baseline screening (n = 12), * discharge or absence at baseline (n = 7), * terminal condition or death (n = 7), * declined participation (n = 2), * other reasons (n = 5).

Overall Study

Analysis population for the primary outcome, as defined in the registry: Denominators vary because outcome-specific at-risk populations were defined by baseline IAD status. Participants with IAD category 2 at baseline were excluded from the study. Incidence of IAD 2A/2B is based on all enrolled participants (n=167). Incidence of IAD 1 or 2 (n=143) excludes those with IAD 1A at baseline. Other rows are restricted to baseline-defined subgroups (no IAD or IAD 1A).

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 Incidence of Incontinence-associated Dermatitis (IAD), measured over 14 Days.

The primary endpoint is the incidence of incontinence-associated dermatitis (IAD), expressed as the number of participants who develop IAD among the relevant participants at risk. Its timeframe is 14 Days. Cumulative incidence describes whether an event occurred during a defined follow-up period; it is different from a measure of how quickly the event occurred.

IAD severity is classified using GLOBIAD, which the registry describes as a visual-inspection classification. Category 1A is persistent redness without clinical signs of infection; category 1B is persistent redness with clinical signs of infection. Category 2A is skin loss without clinical signs of infection; category 2B is skin loss with clinical signs of infection.

The registry gives distinct denominator definitions: participants with IAD category 2 at baseline were excluded from the study; incidence of IAD 2A/2B is based on all enrolled participants (n=167); and incidence of IAD 1 or 2 (n=143) excludes those with IAD. These definitions matter because an incidence proportion depends on which participants were eligible to develop the outcome. The stated denominators should not be treated as interchangeable.

In general, a cumulative-incidence endpoint is useful for describing the proportion of an at-risk population experiencing an event over a specified period. However, the registry record does not report the primary endpoint's event counts by group, an effect estimate, or an uncertainty interval. The endpoint is defined, but its comparative results cannot be interpreted from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel-group exploratory trial and defines a binary primary outcome as the number of participants developing IAD during 14 Days. The record does not describe the statistical methods used to compare groups. The explanations below are general statistical context; they should not be read as a description of an analysis actually performed for this trial.

What does a binary outcome represent?

A binary outcome records whether a participant experienced an event within the defined period. For a cumulative-incidence analysis, the basic descriptive quantities are the number with the event and the number eligible to experience it. A proportion or risk can then describe event occurrence in a group. The registry supplies outcome-specific denominator definitions, but it does not report the primary endpoint's group-specific event counts or analysis results. No group risks or treatment contrasts can therefore be stated from this record.

Comparisons of binary outcomes can be expressed in different ways, such as an absolute difference in risks or a relative contrast. These measures answer related but distinct questions: an absolute contrast concerns the difference in event probabilities, while a relative contrast compares them proportionally. The choice affects interpretation, and the registry record does not identify a primary effect measure. No new effect measure can be reconstructed without the requisite event counts and denominators for each group.

Why do the denominator definitions matter?

An incidence calculation is meaningful only when its population at risk is clearly defined. A participant who already has the outcome at baseline may not be eligible to count as a new incident case under a particular definition. Here, the registry says participants with IAD category 2 at baseline were excluded, and it gives separate populations for incidence of IAD 2A/2B and IAD 1 or 2. A comparison must apply the relevant eligibility definition consistently across the groups. The registry does not report the corresponding primary-outcome denominators by randomized group or explain further how each definition was operationalized.

More generally, outcome-specific denominators may differ because baseline status affects eligibility. They should not automatically be treated as the randomized group sizes, nor should they be combined across outcomes. A difference between an enrollment figure and an outcome-specific population is not, on its own, evidence of missing follow-up or a reporting error. The registry record does not provide enough detail to explain those figures beyond the stated definitions.

How should uncertainty be understood?

General statistical interpretation relies on both an estimate and its uncertainty. A confidence interval describes a range of values that are reasonably compatible with the data and the method used to calculate the interval. Wider intervals indicate less precision; narrower intervals indicate greater precision under the same framework. The interval does not guarantee that the true effect lies within it, and it does not replace consideration of the study design or outcome definition. The registry does not report a primary-outcome estimate or confidence interval.

A hypothesis test and its p-value are another possible part of an analysis. In general, a p-value measures how unusual data at least as incompatible with a stated null hypothesis would be under the model assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. No primary-outcome p-value or testing procedure is reported in the registry record. Accordingly, there is no basis to characterize the trial's primary result as statistically significant or not statistically significant.

What can randomization contribute?

In general, random allocation can help make comparison groups similar with respect to both measured and unmeasured baseline factors, on average. It does not ensure identical groups in a particular trial, prevent missing outcome data, or guarantee that every subsequent analysis is unbiased. Interpretation also depends on how allocation was implemented, whether participants were analyzed according to assigned group, and how outcome data were handled. Although the registry labels allocation randomized, those procedural and analysis details are not reported in the registry record.

What do the planning assumptions mean?

The registry describes a planning illustration based on the observed effect, a stated fraction of that effect, two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. It distinguishes participants per arm for non-time-to-event outcomes from total events for time-to-event calculations. These are planning assumptions, not evidence about how the trial was designed, and any resulting sample-size illustration would not be observed power. The record does not report the trial's own sample-size justification. The primary outcome has no reported comparative estimate in the registry record, so its observed effect cannot be interpreted from the listed results.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including secondary outcomes covering instrumental and visual erythema, erosion, maceration, pain, itch, local intolerances, and adverse events. A list of outcomes does not establish how many statistical tests were conducted, which outcomes were confirmatory, or how the analyses were prioritized. The record reports 0 analyses and does not provide a multiplicity strategy, such as an adjustment for testing several outcomes or a prespecified hierarchy. Those details are not reported in the registry record.

In general, when many outcomes or comparisons are tested, the chance of observing at least one apparently notable result can increase. Statistical approaches to multiplicity can control that risk, but they can also affect precision and interpretation. Without the analysis plan and reported tests, it is not possible to determine whether multiplicity was addressed or how any reported result should be interpreted in that respect.

The record identifies outcome-specific populations for the primary endpoint. It says participants with IAD category 2 at baseline were excluded, that IAD 2A/2B incidence is based on all enrolled participants (n=167), and that IAD 1 or 2 incidence (n=143) excludes those with IAD. It does not report the number of missing primary-outcome observations, reasons for missingness, imputation procedures, or whether any sensitivity analyses were performed. These details are not reported in the registry record.

The analysis population is also unspecified. The record does not say whether primary analyses followed randomized assignment, used a per-protocol population, or applied another definition. The outcome-specific denominators alone do not identify the analysis population or establish how participants with incomplete follow-up were handled. These omissions limit assessment of the estimand, potential bias, and robustness of any comparative result.

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 reports serious and other adverse-event counts separately for each group. For ESENTA™ Skin Barrier Spray, the listed serious-adverse-event risk set is 57 and the number affected is 0; the other-adverse-event risk set is also 57 and the number affected is 0. For Hydrophobes Basisgel DAC, the corresponding risk sets are 57 and 57, with 0 affected in each category. For Standard Care, the risk sets are 53 and 53, again with 0 affected. Deaths are listed as 0 in all three groups.

These figures are counts as recorded in the registry, not estimates of comparative risk. A zero count means no affected participants are recorded in that category among the listed group at risk; it does not establish that the true event risk is zero. With no additional event details or uncertainty estimates reported, the precision of these safety observations cannot be assessed.

The registry does not report serious adverse-event terms, and no top serious terms are listed. The safety figures should be read separately from the primary IAD endpoint: they do not provide primary-outcome event counts or answer whether IAD incidence differed between regimens. Details about adverse-event collection, observation duration, and handling of missing safety information are not reported in the registry record.

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

The registry record establishes that the study was designed as a randomized, parallel-group exploratory comparison of two skin-protection regimens with standard care in geriatric care settings. It defines a primary outcome based on new IAD over 14 Days and records safety counts for serious adverse events, other adverse events, and deaths. These details describe the question and the recorded outcomes; they do not establish a comparative treatment effect.

The primary-outcome results needed to assess the comparison are not reported in the registry record. In particular, there are no group-specific event counts, effect estimates, confidence intervals, or p-values for IAD incidence. It is therefore not possible to determine from this record whether the observed incidence was higher, lower, or similar across groups, or how precise any difference might be. The record's completed status does not fill this gap.

The endpoint definitions also constrain interpretation. The registry identifies different at-risk populations for different IAD incidence categories, including participants with IAD category 2 at baseline being excluded. Without the corresponding group-level denominators and event counts, the outcome-specific incidence cannot be independently evaluated. The secondary outcome list likewise indicates what was measured or intended to be measured, not what results were found.

In general, a trial result is specific to its population, intervention procedures, comparator, follow-up period, outcome definitions, and analysis methods. This record describes an elderly and care-dependent population and a daily product application in addition to standardized mild cleansing. It does not report enough outcome or methods information to judge the magnitude, precision, or robustness of a comparative effect.

The appropriate reading is therefore limited: the registry documents a completed exploratory trial and its planned clinical comparison, but does not provide analyzable primary-outcome findings. The reported zero adverse-event counts are descriptive registry entries and should not be interpreted as proof of absence of harm. Neither benefit nor lack of benefit for any regimen can be concluded from the posted results.

13. Why This Trial Matters Statistically

This trial raises a statistical issue that is common in prevention studies: defining who is at risk of a new event. The primary outcome is cumulative incidence of IAD, but the registry describes different populations for different severity-based definitions. Baseline disease status can determine whether a participant can contribute to an incident outcome, so denominator choices are part of the estimand rather than a minor reporting detail.

The three-group structure also separates two product regimens from a shared standard-care comparator. In general, each pairwise comparison addresses a different question: one compares the film-forming protectant regimen with standard care, another compares the hydrophobic protectant regimen with standard care, and a direct comparison of the two products addresses a distinct contrast. Multiple comparisons can complicate interpretation, especially when several outcomes are also considered. The registry record does not report which contrasts were analyzed or how multiplicity was handled.

The exploratory designation is useful context, but it does not reveal the intended statistical framework or justify treating any result as definitive. The record does not report the trial's own sample-size justification, primary-outcome analysis, or precision estimates. Its planning assumptions describe illustrations rather than observed power or proof of adequate design.

Finally, the record illustrates why completion and enrollment figures are not substitutes for transparent results. Clear reporting of group-specific denominators, event counts, estimates, uncertainty, missing-data handling, and analysis populations is necessary to interpret a randomized comparison. With those primary analyses absent from the registry record, the clinical question remains statistically unresolved in the posted results.

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 trial is that the registry record reports no primary-outcome analyses. It does not provide group-specific IAD events, comparative estimates, confidence intervals, or p-values. As a result, neither effect direction nor precision can be assessed from the posted results.

The record's outcome-population description is specific but incomplete for independent evaluation. It states that participants with IAD category 2 at baseline were excluded, gives n=167 for incidence of IAD 2A/2B, and gives n=143 for incidence of IAD 1 or 2, excluding those with IAD. It does not provide the arm-specific denominators or clarify further how these populations relate to the enrollment figure of 220. The record does not report missing outcome counts or reasons for missingness.

Important methods details are also absent. The registry labels the study randomized and single-masked, but does not identify the masked party or report allocation procedures, the analysis population, the statistical model, adjustment factors, or handling of missing data. The multiplicity approach and the trial's own sample-size justification are not reported in the registry record. These omissions prevent assessment of how the analysis addressed the design and multiple outcomes.

The safety results are limited to recorded counts and risk sets. The registry lists zero serious adverse events, other adverse events, and deaths in each group, but does not provide further collection or follow-up details that would establish the completeness or precision of safety ascertainment. These limitations concern what can be learned from the registry record; they do not establish that the trial itself lacked these procedures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Prevention of Incontinence-associated Dermatitis — NCT05403762.
• Registry record last updated 2026-03-18; status last verified 2026-02.
• Results first posted 2026-03-18.
• 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

NCT05403762 is a completed, randomized, parallel-group exploratory trial comparing ESENTA™ Skin Barrier Spray and Hydrophobes Basisgel DAC, each added to standardized mild cleansing, with standard care consisting of cleansing without an additional protectant. The study concerns elderly nursing-home residents and geriatric patients and lists enrollment of 220. Its primary endpoint is IAD incidence over 14 Days, classified using GLOBIAD.

The registry reports outcome-specific populations of n=167 for IAD 2A/2B incidence and n=143 for IAD 1 or 2 incidence, with baseline eligibility qualifications. It lists secondary outcomes related to skin findings, symptoms, local intolerance, and adverse events. No primary-outcome analyses are reported. The registry records zero serious adverse events, zero other adverse events, and zero deaths in each group, but these counts do not establish comparative safety or effectiveness.