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 Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk (NCT05619003), a na na study. The primary outcome is Number of Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05619003 |
| Phase | NA |
| Condition | Pressure Injury Prevention |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 67 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Coloplast A/S |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned hospital-admitted patients considered at risk of developing a pressure injury. The registry record lists an enrollment of 67. It does not report the eligibility criteria used to define risk, or details such as participants’ ages, diagnoses, baseline pressure-injury status, or other clinical characteristics. Those omissions limit how specifically the study population can be described and to whom the observations might apply.
Intervention
The intervention was Biatain Silicone Sacral dressing, a device studied for preventive use. The study is described as a prospective post-market clinical follow-up investigation of its safety. The registry record does not give further details of dressing application, replacement, adherence, or concurrent preventive care, so the intervention should be understood as the device in the context of the study rather than as a fully specified care package.
Comparator
There was no comparator group. The registry classifies the study as a single-group study with no allocation and no masking. This means its design does not provide a direct comparison with another dressing, usual care, or no dressing. The observed safety counts therefore describe the enrolled group; they do not estimate a difference between treatment strategies.
Primary question
The primary outcome was the number of adverse events over 7 days, with the description focusing on events the investigator considered related to the investigational device during the investigation period, up to 7 days or until discharge. The question is therefore about safety observations during a short, defined period. The registry record does not report a primary-endpoint count or an analysis of that endpoint. The available adverse-event summaries should not be treated as a reported answer to the primary question, particularly because the registry’s adverse-event categories do not establish that each event was considered device-related.
3. Trial Design
This was a prospective, single-arm post-market clinical follow-up study of Biatain Silicone Sacral dressing. Its stated purpose was to investigate safety when the dressing was used as prevention in hospital-admitted patients at risk of developing a pressure injury. The registry lists the study as completed, with a start date of 2022-08-15 and a primary completion date of 2022-12-08. Enrollment was 67.
The design has one group and no allocation to competing interventions. Masking was listed as none. Thus, the group’s observations are not a randomized comparison and are not a like-for-like control comparison. Without a comparator, the study cannot estimate a between-group treatment effect from its design. Its adverse-event counts can be described, but they cannot show what would have occurred in a similar group receiving a different approach.
The intervention is recorded as a device: Biatain Silicone Sacral dressing. The primary outcome was the number of adverse events over 7 days. Its description specifies adverse events considered related to the investigational device by the investigator during the investigation period, up to 7 days or until discharge. A secondary outcome was the number of device deficiencies. The record lists two outcome measures, but it does not report analyses for them.
The registry identifies Coloplast A/S as sponsor and describes the study as a post-market clinical follow-up investigation. Further information about sites, recruitment procedures, eligibility criteria, the number of dressings used, care given alongside the device, or follow-up procedures is not reported in the registry record. The record also does not report a comparator protocol or an allocation sequence; in a single-group study, no such comparison is described.
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 | Biatain Silicone Sacral Dressing |
|---|---|
| STARTED | 67 |
| COMPLETED | 66 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Biatain Silicone Sacral Dressing |
|---|---|
| Adverse Event | 1 |
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.
Population: Numbers of participants constitutes the ITT population (participants exposed to the investigational device with information on at least one endpoint) and differ from the overall (safety population constituted by all subjects with a valid informed consent)
| Characteristic | Unit | Biatain Silicone Sacral Dressing |
|---|---|---|
| Participants analysed | 66 | |
| Age, Continuous | years | 70.5 (46 to 92) |
| Sex: Female, Male: Female | Participants | 39 |
| Sex: Female, Male: Male | Participants | 27 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Denmark | Participants | 66 |
| BMI | kg/m2 | 27.4 (15 to 50) |
| Urinary incontinence | Participants | 18 |
| Faecal incontinence | Participants | 12 |
| Braden Scale Score | scores on a scale | 15.9 (11 to 18) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Adverse Events, measured over 7 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Adverse events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of adverse events. Its unit is adverse events, so the intended measure is a count of events, rather than a measure of pressure-injury incidence or a comparative effect. The endpoint description focuses on events the investigator considered related to the investigational device. The observation period is 7 days, or until discharge, as stated in the registry record.
A count of adverse events is used to describe the safety experience observed during a defined period of device use. It can make the reported burden of events visible, but interpretation depends on how events were identified, classified, and attributed. In particular, an event’s occurrence and its assessment as related to a device are separate judgments. The endpoint description assigns the relatedness judgment to the investigator; the registry record does not provide further criteria for making that judgment.
The primary endpoint result and its analysis are not reported in the registry record. The adverse-event summary includes counts of people affected by serious and other adverse events, but those summaries do not supply the primary count of device-related events. Counts of affected people and counts of events are not interchangeable: one person may experience more than one event, and an event count may include multiple events for a person. The record does not provide enough detail to reconcile those measures or determine how the primary endpoint was tabulated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a single-group study of Biatain Silicone Sacral dressing and reports safety summaries for that group. Its adverse-event listing reports 4 affected by serious adverse events and 5 affected by other adverse events, with 67 listed as at risk for each category. It also reports 1 death. These are descriptive figures from the registry record, not results of a comparison with another group. The categories may overlap, so they should not be added or treated as mutually exclusive.
The serious-event terms listed are Dyspnoea, Death, Aspiration, and Intraabdominal bleeding, each with 1.5%. Those entries describe terms and percentages in the adverse-event listing. They do not by themselves establish that the events were caused by the dressing, nor do they establish that they were judged related to the device by the investigator. The record does not report event-level attribution for these terms. The one death appears in the same safety summary, but the record does not explain its relationship to other listed categories or to the device.
The main interpretive gap is that the primary endpoint is a count of adverse events considered device-related by the investigator, yet a primary-endpoint result and analysis are not reported in the registry record. The reported summaries of people affected by serious or other adverse events cannot be substituted for that outcome. They provide a limited account of recorded safety observations, not a complete account of the primary endpoint as defined.
Precision also cannot be assessed for the primary outcome from the registry record: it does not report an estimate, confidence interval, or other analysis for that endpoint. In general, a confidence interval expresses the range of values compatible with an estimate under the analysis assumptions; without a reported estimate and interval, the uncertainty around the primary result cannot be evaluated. Nor does the single-group design separate the device’s contribution from background health events, other care, or the clinical circumstances of hospitalization.
The study’s completed status does not resolve these limitations. Completion is a registry status, not evidence that every planned outcome was reported or analyzed. The record lists 0 analyses. That means analyses are not reported in the record; it does not establish what analyses may or may not have been conducted outside the registry. The data can therefore be read as a descriptive safety record with important gaps, rather than as a conclusive test of device-related risk or a comparative assessment of preventive benefit.
9. Statistical Methods Explained
The study is a single-group investigation, which determines what kinds of statistical conclusions are available. A one-group study can describe observations in the enrolled group, such as counts of adverse events or people affected. It cannot directly estimate a treatment contrast against a control group because no comparator group is included. Differences over time or from an external benchmark would require additional data and assumptions; such comparisons are not reported in the registry record.
What does a count endpoint represent?
A count endpoint records how many events occur over a specified observation period. It differs from a binary endpoint that records whether a participant experienced at least one event. The same person may contribute more than one event to a count, while a participant-based summary ordinarily counts that person once in an affected category. This distinction matters for the primary outcome, whose unit is adverse events, and for the adverse-event summaries, which report numbers affected. The registry record does not report enough detail to map the affected-person summaries to the primary event count.
Counts often require careful consideration of exposure time and variation between people. If observation periods differ, a count over a fixed period may not represent the same amount of time at risk for every participant. Here, the primary timeframe is stated as 7 days, while its description allows follow-up until 7 days or discharge. The record does not report individual follow-up times or an analysis accounting for differing observation time. General statistical practice may use event rates or count models when exposure time varies, but the registry record does not report such an analysis for this study.
Why can count data be more variable than a simple model expects?
Some count-data methods assume that the variability is closely linked to the average count. In real clinical data, event counts may vary more than that assumption allows, a feature called over-dispersion. It can arise when participants differ in underlying risk, when events cluster within people, or when other sources of heterogeneity affect counts. If over-dispersion is present but ignored, standard errors may be too small and confidence intervals may be too narrow. This is a general statistical consideration, not a finding about this study: the registry record does not report a fitted count model, an over-dispersion assessment, or a confidence interval for the primary endpoint.
For event counts, analysts may also need to distinguish the number of events from the number of people experiencing events, account for observation time, and state how recurrent events are handled. These choices affect both the estimand—the quantity the analysis is intended to describe—and its uncertainty. The primary endpoint description gives an event count and a timeframe, but further details on counting rules, recurrent events, and missing observations are not reported in the registry record. No specific model or estimation method can therefore be attributed to the trial.
What does the single-arm design allow?
In a randomized comparative study, treatment groups can be compared under a defined assignment process. In this study, allocation is listed as not applicable and the model is single group. The observed adverse-event summaries consequently describe the study group, without a randomized reference for separating device-related effects from other causes. Even when an investigator judges an event related to a device, that is an attribution made under the study’s assessment process; it is not the same as a randomized estimate of causation.
Masking is listed as none. In general, lack of masking can affect judgments that require interpretation, including event attribution, because knowledge of the treatment may influence assessment. This is a potential design consideration, not evidence that any assessment was biased. The record does not report procedures intended to standardize or independently review relatedness assessments, so their influence cannot be evaluated from the registry record.
How should planning illustrations be interpreted?
Planning illustrations are not observed trial results. The stated assumptions for those illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. The illustration is explicitly not the trial’s own design. It assumes a two-arm allocation even though the registry describes a single-group study, so it should be read as a hypothetical planning exercise rather than a description of how this study was designed or analyzed.
For non-time-to-event outcomes, the stated convention is to express the planning quantity as participants per arm; for time-to-event outcomes, it is the total number of events. Such calculations depend on the assumed effect and model. They do not show the probability that the completed study detected an effect, and they are not observed power. Because the registry record does not report a primary-endpoint analysis or estimate, the connection between an observed effect and the clinical study result cannot be evaluated from the record. The planning assumptions should not be used as a substitute for a reported trial analysis.
More broadly, statistical interpretation would require a clear definition of the analysis population, endpoint handling, follow-up completeness, missing-data approach, and method for quantifying uncertainty. Those details are not reported in the registry record. The registry lists 0 analyses, so no model, test, or inferential procedure for the outcomes can be identified. It is therefore appropriate to describe the available figures as recorded counts and to avoid attaching unreported inferential conclusions to them.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the primary number of adverse events and the secondary number of device deficiencies. It reports 0 analyses. No multiplicity strategy is reported in the registry record. In general, when several outcomes are tested, the chance of at least one apparently notable result can increase unless the analysis plan accounts for multiple testing. That general issue cannot be quantified for this study because the record does not report outcome analyses, tests, or a multiplicity procedure.
Missing-data methods are not reported in the registry record. The primary outcome timeframe is 7 days or until discharge, but the record does not state how early discharge, incomplete follow-up, or unavailable event information was handled. It also does not report whether participants with missing observations were excluded, retained for some outcomes, or handled using an imputation method. No missingness assumptions or sensitivity analyses are reported. These details matter because incomplete observation can affect how many events are captured and how representative the reported summaries are.
The analysis population is not reported in the registry record. Although enrollment is listed as 67, the record does not specify which participants contributed to each outcome analysis or whether the outcome summaries use all enrolled participants. Nor does it report a prespecified analysis set. The available safety counts should therefore be read as registry summaries, without assuming a particular population definition.
Interim analyses and a statistical analysis plan are not reported in the registry record. Their absence from the registry entry does not establish whether such procedures existed elsewhere. Without these details and without reported outcome analyses, readers cannot assess whether outcome selection, analysis populations, missing observations, or multiple testing influenced the statistical results.
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 |
|---|---|---|---|
| Biatain Silicone Sacral Dressing | 4 | 67 | 6.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Biatain Silicone Sacral Dressing | 1 of 67 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Biatain Silicone Sacral Dressing | 5 of 67 |
Most frequent serious adverse event terms
| Event term | Organ system | Biatain Silicone Sacral Dressing |
|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 67 |
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 67 |
| Aspiration | Respiratory, thoracic and mediastinal disorders | 1 of 67 |
| Intraabdominal bleeding | Surgical and medical procedures | 1 of 67 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Biatain Silicone Sacral Dressing |
|---|---|---|
| Incision site pain | Nervous system disorders | 5 of 67 |
Serious events with the highest arm-level rate: dyspnoea (1.5%), death (1.5%), aspiration (1.5%), intraabdominal bleeding (1.5%).
The adverse-event summary lists 4 affected by serious adverse events and 5 affected by other adverse events; each category lists 67 at risk. It also lists 1 death. The serious-event terms are Dyspnoea, Death, Aspiration, and Intraabdominal bleeding, each reported as 1.5%. These figures describe what the registry records for the study group. The serious and other categories may overlap, and the death may also be represented in a serious-event category, so the counts should not be added together.
These summaries are distinct from the primary endpoint. The primary outcome is the number of adverse events considered related to the investigational device by the investigator during the stated period. The adverse-event summary does not establish that all listed events were considered device-related, and the registry record does not report a primary-endpoint count or an event-level attribution for the listed terms. A count of people affected also differs from a count of events, since one person may have more than one event.
The reported terms and percentages should not be read as evidence that the dressing caused the events. The study has no comparator group, and the registry does not report causal attribution for the listed safety terms. These figures are descriptive observations, not a comparative safety estimate.
12. What the Result Does, and Does Not, Mean
The record documents a prospective, single-arm post-market study of Biatain Silicone Sacral dressing in hospital-admitted patients at risk of pressure injury. It records an enrollment of 67 and reports adverse-event summaries for the study group. The listings include serious adverse events, other adverse events, a death, and several serious-event terms with associated percentages. These observations are relevant to describing what the registry records during the investigation, but they do not by themselves answer every safety question about the device.
The primary endpoint was the number of adverse events considered related to the investigational device by the investigator during 7 days or until discharge. That result and its analysis are not reported in the registry record. The available participant-level adverse-event summaries are not a substitute for the primary event count, and the listed terms do not establish device-relatedness. The record also does not provide a comparative estimate against another preventive approach.
Consequently, the information does not establish whether the dressing changes pressure-injury risk or whether its use causes or prevents any particular adverse event. A single-group description cannot determine what outcomes would have occurred in a comparable group without the dressing or with another intervention. The absence of a reported primary analysis also prevents assessment of the precision of the primary safety estimate. No conclusion about treatment effectiveness or comparative safety follows from these registry summaries alone.
The study’s completed status and its safety listings are meaningful as a record of the investigation, but completeness of reporting is a separate issue. The registry reports no analyses, and details about eligibility, event-counting procedures, missing observations, and analysis populations are not reported in the registry record. Those limits should stay in view when interpreting the counts. The record supports a cautious descriptive reading, not an unreported inferential or causal conclusion.
13. Why This Trial Matters Statistically
Statistically, the study illustrates the difference between collecting safety observations and reporting an analyzable endpoint result. Its primary outcome is a count of adverse events considered device-related by the investigator, but the registry record does not report the count or an analysis. Meanwhile, the adverse-event listing describes numbers of people affected and serious-event terms. Recognizing that these are different quantities prevents an affected-person summary from being mistaken for the primary event-count result.
The single-group design is also important to interpretation. It allows safety observations in the enrolled group to be described, but it supplies no randomized comparison for estimating how outcomes differ under another approach. This is especially relevant for clinical safety data, where events may reflect underlying illness, hospitalization, or other care as well as exposure to a device. The record’s investigator-relatedness description gives a defined attribution concept, but without a comparative group it does not provide a causal contrast.
The study also shows why endpoint definitions, follow-up, and analysis details matter. The primary timeframe is 7 days or until discharge, and the record does not report how differences in observation time or incomplete follow-up were handled. Nor are the population used for outcome analyses, missing-data methods, or multiplicity procedures reported. These details affect what a count represents and how certain an estimate is.
Finally, hypothetical planning illustrations should be distinguished from actual design and results. Their stated assumptions describe a planning exercise, while the registry classifies the clinical study as single group and reports no outcome analyses. Keeping those roles separate avoids treating a planning calculation as evidence of observed power or as the trial’s own statistical analysis. The central statistical lesson is to match each claim to the design, endpoint, and analysis that the registry actually reports.
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 single-arm design is the central limitation for comparative interpretation. With no control group and no allocation, the study cannot estimate a contrast between Biatain Silicone Sacral dressing and another preventive strategy. The lack of masking is also recorded, and the registry does not report procedures for independent or blinded assessment of adverse-event relatedness. This is relevant because the primary endpoint depends on an investigator’s judgment, although the record does not establish that any judgment was biased.
The primary endpoint result and analysis are not reported in the registry record. The safety summaries do not fully resolve that gap because they describe numbers affected and listed terms, rather than the primary count of events judged related to the device. The record does not explain whether the adverse-event categories overlap or how listed terms map to the primary endpoint. It therefore does not permit a complete reconstruction of the primary safety result.
The follow-up description is limited to 7 days or until discharge. The record does not report individual observation time or how early discharge was handled analytically. Details of the risk definition, eligibility criteria, baseline clinical characteristics, care provided alongside the dressing, and device-use procedures are also not reported in the registry record. These omissions make it difficult to assess the population’s clinical context or the applicability of the observations to other settings.
Finally, the record lists no analyses and does not report the analysis population, missing-data approach, statistical model, uncertainty estimates, or multiplicity strategy. These gaps limit assessment of precision and potential sources of bias. The planning assumptions describe an illustration rather than the study’s own single-group design and should not be used to fill the reporting gaps.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk — NCT05619003.
- Registry record last updated 2026-05-29; status last verified 2025-09.
- Results first posted 2025-09-10.
- 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 NCT05619003, a completed prospective single-arm post-market clinical follow-up study of Biatain Silicone Sacral dressing for pressure injury prevention in hospital-admitted patients at risk. Enrollment was 67. The study started on 2022-08-15, with primary completion on 2022-12-08. The primary outcome was the number of adverse events over 7 days, described as events the investigator considered related to the device during the investigation period, up to 7 days or until discharge. The secondary outcome was the number of device deficiencies.
The adverse-event summary lists 4 affected by serious adverse events, 5 affected by other adverse events, and 1 death, with 67 listed at risk for each adverse-event category. Four serious-event terms are listed at 1.5% each. These are descriptive registry summaries and do not establish device-relatedness for each event. The primary endpoint result and analysis are not reported in the registry record; the record lists 0 analyses. There was no comparator group, and masking was listed as none. Details on missing data, analysis populations, and statistical methods are not reported in the registry record.