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 SQ53 Disinfectant Wipes for Prevention of CRBSI (NCT04822467), a randomized na study. The primary outcome is Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04822467 |
| Phase | NA |
| Condition | Catheter-related Bloodstream Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 59 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The Cleveland Clinic |
| Results posted | Yes |
2. Clinical Question
Population
Patients receiving home parenteral nutrition who use a catheter. The registry describes analysis of all enrolled subjects and of those meeting protocol-defined compliance rates; it also notes that some subjects were removed because they could not continue under the protocol.
Intervention
Daily catheter cleaning with SQ53 wipes. The record describes SQ53 as an antimicrobial, sporicidal solution on a platform of quaternary ammonium chloride compounds, posted in a sterilized single-wipe pack.
Comparator
Daily catheter cleaning with ethanol-based wipes, identified in the arm description as the Standard Wipe. The official title calls the trial placebo-controlled, while the listed comparator intervention is an ethanol wipe.
Primary question
Whether the groups differed in the number of catheter-related bloodstream infections over 6 months, expressed as infections per 1000 days with catheter. The registry record does not report the primary outcome values or a between-group result.
3. Trial Design
This was a randomized, single-blind, parallel-group clinical trial of SQ53 wipes for catheter cleaning in patients receiving home parenteral nutrition. The registry lists 59 participants enrolled and identifies The Cleveland Clinic as the sponsor. The record marks the trial completed, with a start date of 2021-12-10 and a primary completion date of 2022-12-07.
The two listed interventions were SQ53 Wipe and Ethanol Wipe. Arm descriptions call the ethanol-based wipe arm “Standard Wipe” and state that participants in both groups received a supply of wipes for daily use. The official title describes the study as placebo-controlled, but the listed comparator is an ethanol-based wipe; the record does not explain the use of the placebo label or provide further information about how the comparison was implemented.
Masking is recorded as single blind. The record does not specify which participants, investigators, or other trial personnel were masked. Allocation is recorded as randomized, but details of sequence generation, concealment, or the allocation procedure are not reported in the registry record. The listed phase is NA.
The primary endpoint was catheter-related bloodstream infections over 6 months, expressed as infections per 1000 days with catheter. Catheter exchange rates are listed as a secondary outcome. The registry record does not report primary outcome values, a group comparison, or analyses for either outcome. It describes a target population and a compliance-based analysis population, but does not provide the number analyzed in either population.
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 | Standard Wipe | SQ53 Wipe |
|---|---|---|
| STARTED | 29 | 30 |
| COMPLETED | 29 | 30 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Data analysis was done on all subjects enrolled as well as those that met the protocol defined compliance rates. Subjects were removed due inability to continue with the protocol (moving to different Home Parenteral Nutrition service or not following treatment guidelines)
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 | Standard Wipe | SQ53 Wipe | Total |
|---|---|---|---|---|
| Participants analysed | 29 | 30 | 59 | |
| Age, Continuous | Years | 52.7 (SD 15) | 51.7 (SD 17.6) | 52.2 (SD 16.2) |
| Sex: Female, Male: Female | Participants | 21 | 26 | 47 |
| Sex: Female, Male: Male | Participants | 8 | 4 | 12 |
| Race/Ethnicity, Customized: Caucasian | Participants | 27 | 28 | 55 |
| Race/Ethnicity, Customized: African American | Participants | 1 | 2 | 3 |
| Race/Ethnicity, Customized: Asian or Pacific Islander | Participants | 1 | 0 | 1 |
| Region of Enrollment: United States | participants | 29 | 30 | 59 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Inter-Quartile Range |
| Unit | Infections per 1000 days with catheter |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint is the number of catheter-related bloodstream infections (CRBSI) at 6 months, reported as infections per 1000 days with catheter. It is described as a reduction in the number of CRBSI experienced by participants over a six-month period. The rate formulation relates infection events to time with a catheter, rather than treating every participant’s observation period as necessarily identical.
In general, an event rate uses exposure time as its denominator. This can be useful when participants contribute different amounts of time at risk, because the rate expresses events relative to the accumulated exposure. Interpretation still depends on how events and catheter-days are defined and collected. Those operational details are not reported in the registry record.
The endpoint description lists the mean as its summary measure and the inter-quartile range as its dispersion measure. These labels indicate that the planned summary was not described solely as a count or as a proportion of participants with at least one infection. However, the registry record contains no group-level means, inter-quartile ranges, event counts, exposure totals, or estimated treatment contrast. It therefore does not allow the infection rates in the two groups, or the precision of any difference, to be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives the trial question, design, and primary endpoint definition, but it does not provide the primary outcome results. There are no reported group-specific CRBSI rates, inter-quartile ranges, differences, confidence intervals, or p-values. Accordingly, the direction and size of any observed group contrast, and its statistical precision, cannot be described from this record.
The planned endpoint is a rate per 1000 days with catheter over 6 months. For a rate comparison to be interpreted, readers would need the event information and the exposure time contributing to each group, along with a clearly defined contrast and its uncertainty. None of those numerical primary-outcome results is reported in the registry record. The endpoint description identifies a mean and an inter-quartile range, but does not give their values.
The registry lists 59 participants enrolled. That enrollment figure does not by itself establish how many participants contributed to the primary analysis, how much catheter exposure time was observed, or how many CRBSI events occurred. The record says that analyses were performed on all enrolled subjects and on those meeting protocol-defined compliance rates, and notes removals for inability to continue. It does not give population-specific counts or outcomes.
The serious-adverse-event entries list zero affected in each group, while the other-adverse-event entries list one affected in each group. Deaths are listed as zero in both groups. These safety counts are descriptive entries and do not fill the gap in the primary endpoint results. The registry does not define the “other” category or provide further detail about those events.
Statistical significance and clinical importance are distinct questions. In general, a p-value addresses compatibility with a specified statistical model and null hypothesis, while a confidence interval conveys a range of values compatible with the observed data under that model. Neither can be assessed for the primary endpoint because the registry record does not report those statistics or the data needed to evaluate them. The record supports a description of what the trial was designed to compare, not a conclusion about the observed infection-rate comparison.
9. Statistical Methods Explained
The registry identifies a randomized, single-blind, parallel-group trial. These design features describe how participants were assigned, how masking was characterized, and how the comparison was organized. They do not, by themselves, provide the statistical methods used to analyze the primary endpoint. The registry record does not report an analysis model, an estimate of the group contrast, or a statistical test for the CRBSI rate.
What does a rate endpoint represent?
In general, an event rate relates the number of observed events to the time participants spend exposed or at risk. For this trial, the stated unit is infections per 1000 days with catheter, and the timeframe is 6 months. Using exposure time as a denominator can make rates more interpretable when time under observation differs between participants. To reproduce or evaluate a rate, readers would need event counts and the corresponding exposure totals, as well as definitions for qualifying events and exposure time. These details and numerical results are not reported in the registry record.
The primary outcome lists the mean as its parameter and the inter-quartile range as its dispersion measure. In general, the mean describes a distribution’s average, while the inter-quartile range describes the spread between its middle portions. These summaries alone do not specify how the two treatment groups were compared. The registry does not state whether the analysis used a model for rates, adjusted for any covariates, accounted for repeated observations, or used another approach.
Why can event-rate data require special care?
In general, count data often vary more than a simple Poisson model expects, a situation called over-dispersion. When over-dispersion is present, a model that assumes less variability may produce uncertainty estimates that are too narrow. General approaches can account for extra variation, but the registry record does not report whether over-dispersion was assessed or how it was handled in this trial. It also does not report the distribution of event counts or the model assumptions used.
Rates can also be affected by differences in the amount of observed exposure. In general, a rate comparison should make clear how exposure time was accumulated and whether participants with incomplete follow-up contributed the time they were observed. The record’s endpoint unit identifies catheter-days as the exposure basis, but does not report group-specific exposure totals, follow-up completeness, or the handling of time after a participant stopped following the protocol.
What would an estimate and confidence interval add?
In general, an estimated contrast summarizes the observed difference or ratio between groups, depending on the chosen method. A confidence interval expresses uncertainty around that estimate under the analysis model; it is not a guarantee that the true value lies within the interval. A narrow interval generally indicates greater precision than a wide one, but interpretation also depends on the endpoint scale and the range of values that would matter clinically. The registry record reports no primary estimate or confidence interval, so neither the size nor precision of the comparison can be assessed.
A p-value, in general, measures how unusual data at least as incompatible with a specified null hypothesis would be under a statistical model. It does not measure 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 is reported in the registry record. Without an estimate and its uncertainty, a p-value alone would also be insufficient to describe the result.
What do planning calculations mean?
In general, a sample-size planning illustration asks how many participants might be needed under stated assumptions to detect a chosen effect at a chosen power and significance level. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. The assumptions expressly distinguish planning illustrations from the trial’s own design. They do not establish the trial’s original sample-size justification, and the registry record does not report that justification.
Planning sample sizes are not observed power. In general, observed power calculated from an estimated effect largely restates information about the estimate and its uncertainty; it should not be treated as a separate measure of evidence. Planning illustrations instead depend on assumptions about the effect to detect and the analysis. No actual sample-size illustration values are reported in the registry record.
The record reports zero analyses. It does not describe a statistical analysis plan, interim analyses, model specifications, covariate adjustment, missing-data methods, or sensitivity analyses. Consequently, the statistical concepts above provide general context for the endpoint, not a description of methods confirmed to have been used in the trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and one secondary outcome, catheter exchange rates. It does not report outcome results or analysis details for either. The record does not describe a plan for handling multiple outcomes, multiple comparisons, or repeated testing. Whether any multiplicity adjustment was planned or used is not reported in the registry record.
The primary outcome description says that data analysis was done on all enrolled subjects and on subjects meeting protocol-defined compliance rates. It also says subjects were removed because they could not continue with the protocol, including moving to a different home parenteral nutrition service or not following treatment guidelines. The record does not define the compliance threshold, specify how the two analysis populations were formed, or report how many participants were included in each.
In general, missing outcome information can affect estimates when the reasons for missingness relate to participants’ outcomes or treatment. Assessing that possibility requires information about follow-up, missingness, and analysis choices. The registry record does not report the amount or pattern of missing primary-outcome data, the handling of incomplete follow-up, or any imputation or sensitivity analysis.
Randomization describes assignment, but does not by itself establish that every participant was included in every analysis or that missing data had no effect. The record does not report whether analyses followed an intention-to-treat principle, whether any participants were excluded from the primary analysis beyond the removals described, or how participants who discontinued contributed catheter exposure time and infection events.
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 |
|---|---|---|---|
| Standard Wipe | 0 | 29 | 0.0% |
| SQ53 Wipe | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard Wipe | 0 of 29 |
| SQ53 Wipe | 0 of 30 |
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 |
|---|---|
| Standard Wipe | 1 of 29 |
| SQ53 Wipe | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Standard Wipe | SQ53 Wipe |
|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | 1 of 29 | 1 of 30 |
The registry safety entries list zero serious adverse events among 29 at-risk participants in the Standard Wipe group and zero among 30 at-risk participants in the SQ53 Wipe group. In the other-adverse-event entries, one affected participant is listed in each group, with 29 and 30 at risk, respectively. Deaths are listed as zero in both groups.
These are descriptive counts, not a complete safety analysis. The registry record does not define the “other” category, provide event descriptions, state how events were collected or classified, or report timing, severity, relatedness, or statistical comparisons. The “top serious terms” list is empty. The at-risk counts in these safety entries should not be taken as confirmation of the number included in the primary endpoint analysis, which is not reported.
Zero serious events recorded in these entries does not establish that serious events were impossible or that the groups were equivalent in safety. In general, counts should be interpreted alongside the observation period, event definitions, completeness of reporting, and uncertainty. Those details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, single-blind, parallel-group trial compared daily SQ53 wipes with daily ethanol-based wipes in patients receiving home parenteral nutrition. Its primary question concerned catheter-related bloodstream infection rates per 1000 days with catheter over 6 months. The registry also records catheter exchange rates as a secondary outcome and lists adverse-event counts.
It does not establish what the primary outcome comparison showed. No group-specific infection rates, event totals, exposure totals, estimated contrast, confidence interval, or p-value are reported. Without these, readers cannot determine the observed direction or magnitude of the difference, how precisely it was estimated, or whether the groups’ results were compatible with a range of clinically meaningful effects.
The enrollment count is not a substitute for an analyzed sample size, and the safety entries are not a substitute for the primary outcome. The registry notes analyses of all enrolled subjects and those meeting protocol-defined compliance, as well as removals for inability to continue; it does not say how many participants contributed to either analysis or how missing observations were handled.
In general, a trial’s design and its results answer different questions. Randomization describes the intended allocation method, while outcome estimates describe what was observed and quantify uncertainty. The design information is useful for understanding the intended comparison, but cannot be used to infer an effect in the absence of reported outcome data.
No conclusion about whether one wipe reduced infections relative to the other can be drawn from the information recorded. That limitation concerns the absence of reported outcome results; it is not evidence that the treatments were the same, nor evidence that one was better. The appropriate reading is that the registry documents the trial and endpoint but does not report the primary comparison needed to characterize the result.
13. Why This Trial Matters Statistically
This trial addresses a specific measurement problem: comparing catheter-related bloodstream infections in patients receiving home parenteral nutrition when the endpoint is expressed relative to days with a catheter. For statistical interpretation, that rate scale makes exposure time part of the outcome definition. Readers need both event information and time-at-risk information to understand the comparison.
The design also highlights the importance of defining analysis populations. The registry describes analyses among all enrolled subjects and among those meeting protocol-defined compliance, while also noting removals when participants could not continue. Those populations can answer different questions in general, particularly when adherence or continued follow-up affects who contributes outcome data. Here, their sizes and results are not reported, so their implications cannot be assessed.
Another statistical issue is precision. A randomized comparison is most informative when an effect estimate is accompanied by uncertainty and a clear account of the data included. The record gives an enrollment count but does not provide the infection-rate estimates, exposure totals, or confidence intervals. Statistical significance, precision, and practical importance therefore cannot be evaluated for the primary endpoint.
The record is also a reminder to distinguish a study’s planning assumptions from its observed findings. It describes assumptions for planning illustrations, but those assumptions are not evidence of the trial’s original sample-size rationale or of its results. Planning calculations can help show how design choices relate to detectable effects in general; they cannot replace a reported treatment contrast.
For this trial, the statistically useful information is therefore the stated comparison, endpoint scale, and analysis-population description, alongside the clear limits of the outcome reporting. The absence of a posted primary comparison prevents assessment of the central statistical question the trial was designed to address.
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 of the registry record for interpreting this trial is that it does not report numerical results for the primary endpoint. It also does not provide a between-group estimate, confidence interval, or p-value. The stated mean and inter-quartile range are summary labels, not outcome values.
The endpoint is described as infections per 1000 days with catheter, but the record does not give the number of infections or catheter-days in either group. It does not report event definitions, event adjudication, or how exposure time was calculated. Without those details, the reported endpoint cannot be reconstructed or independently evaluated from the record.
The registry describes two analysis populations and reasons some subjects were removed, but does not state the number analyzed in either population, the compliance definition, or how incomplete follow-up was handled. It also does not report whether analyses followed an intention-to-treat principle, whether exclusions were made, or what sensitivity analyses were conducted.
Important design and analysis details are not reported in the registry record, including the masking procedure, randomization sequence and concealment, statistical model, covariate adjustment, handling of over-dispersion, and any interim analyses. The record does not provide the trial’s sample-size justification. The planning assumptions it does describe should not be taken as that justification.
Finally, the record calls the study placebo-controlled in its official title, while describing the comparison arm as an ethanol-based Standard Wipe. It does not explain this terminology. The safety entries are limited to counts and do not define the other-adverse-event category or provide event details. These limitations restrict interpretation of both efficacy and safety from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: SQ53 Disinfectant Wipes for Prevention of CRBSI — NCT04822467.
- Registry record last updated 2023-06-02; status last verified 2023-05.
- Results first posted 2023-06-02.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT04822467 is a completed randomized, single-blind, parallel-group trial sponsored by The Cleveland Clinic. The record lists 59 participants enrolled and compares daily SQ53 wipes with daily ethanol-based wipes among patients receiving home parenteral nutrition.
The primary outcome is catheter-related bloodstream infections over 6 months, expressed as infections per 1000 days with catheter; catheter exchange rates are listed as a secondary outcome. The registry describes analyses of all enrolled subjects and those meeting protocol-defined compliance, and notes removals for inability to continue.
Primary and secondary outcome results and statistical comparisons are not reported in the registry record. Safety entries list zero serious adverse events and zero deaths in both groups, with one affected participant in the other-adverse-event category in each group. The record does not provide further definitions or event details.