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 The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing (NCT01230489), a randomized na study. The primary outcome is Time From Catheter Implantation to First Exit Site Infection..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01230489 |
| Phase | NA |
| Condition | Renal Failure |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Missouri-Columbia |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned people with renal failure who had a newly created catheter exit site after surgical implantation. The registry does not report further eligibility criteria, participant characteristics, or the number assigned to each group.
Intervention
The intervention was MediHoney used as part of exit-site wound care. The planned dressing replaced a dry 2 x 2 dressing with a honey 2 x 2 dressing, with honey ointment applied to indentations in the exit-site wound before the dressing was placed.
Comparator
The comparator was the current standard of care for postoperative exit sites at the participating institutions. The registry does not describe the specific standard-care procedures beyond identifying this as the control group.
Primary question
The primary outcome was time from catheter implantation to the first exit-site infection, observed until infection or two years, whichever occurred first. The trial aimed to assess whether the wound-care approach changed that time. The registry reports that no analysis occurred, so it does not answer the comparative question.
3. Trial Design
The registry describes a randomized, open-label, controlled clinical trial with a parallel-group model. Participants were to receive either MediHoney or standard care for postoperative catheter exit sites. Because masking was listed as none, the trial was not blinded. The registry does not report the randomization procedure, allocation concealment, or how many of the enrolled participants entered each group.
The recorded enrollment was 13. The condition listed was renal failure, and the intervention was classified as biological. The study began in 2011-01, had a primary completion date of 2016-11-28, and is recorded as terminated. The registry attributes termination to loss of communication between the surgical and research departments.
The planned primary outcome was time from catheter implantation to the first exit-site infection, with follow-up ending at infection or two years, whichever was shortest. The study description also states an aim of preventing bacterial colonization, but the record lists one outcome measure and does not provide an analysis of it. There are no posted arm-specific outcome estimates or inferential results. The registry does not report the planned sample-size justification, detailed analysis plan, or reasons for the enrollment total.
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: Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
Overall Study
| Stage | Surgical Catheter Dressings |
|---|---|
| STARTED | 13 |
| COMPLETED | 8 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Surgical Catheter Dressings |
|---|---|
| Death | 2 |
| Adverse Event | 2 |
| Treatment modality changed | 1 |
Analysis population for the primary outcome, as defined in the registry: Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
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: Participants were assigned to receive the standard care dressing or the MediHoney dressing. It is unknown how many were assigned to each arm due to research staff no longer being available.
| Characteristic | Unit | Surgical Catheter Dressings |
|---|---|---|
| Participants analysed | 13 | |
| Age, Customized: Age 18 - 90 years | Participants | 13 |
| Sex/Gender, Customized: Unknown | Participants | 13 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Time From Catheter Implantation to First Exit Site Infection., measured over Two years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the elapsed time from catheter implantation until the first exit-site infection. Follow-up was to stop at the first infection or two years, whichever was shorter. This is a time-to-event outcome: it captures not only whether an event was observed but also when it occurred during follow-up.
In general, time-to-event endpoints can make use of information from participants who have different follow-up durations. Participants who have not had the event by the end of observation are usually treated as censored at their last known follow-up, rather than as though an event occurred. That distinction matters because the event time is not known for those participants. The registry does not report the censoring approach, follow-up completeness, or an analysis of event times.
Time to first infection was relevant to the stated aim of assessing exit-site healing and infection prevention. However, the registry says that data were unavailable because no analysis occurred. It therefore provides no event counts by arm, time-to-event summary, treatment-effect estimate, or confidence interval for this endpoint. The planned measure should not be mistaken for a reported finding.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the registry contains no analysis of the primary outcome. Although the trial enrolled 13 participants and specified time from catheter implantation to first exit-site infection as its primary measure, the registry states that data were unavailable because no analysis occurred. There is consequently no reported comparison of MediHoney with standard care for this outcome.
No estimate of the difference between groups, relative event rate, or time-to-event effect is reported. There is no confidence interval or p-value for the primary endpoint. Without these results, the direction and precision of any treatment contrast cannot be assessed. The record does not establish whether infection occurred earlier or later in either group, how many events occurred, or whether follow-up differed between groups.
In general, a confidence interval describes the range of effect estimates compatible with the data and the statistical method used. A narrow interval can indicate greater precision, while a wide interval can indicate substantial uncertainty. Here, no primary-outcome interval is reported, so the precision of a possible effect cannot be evaluated. The enrollment total alone does not supply that missing information.
The listed safety figures are also descriptive rather than an efficacy analysis. They appear under a combined group titled Surgical Catheter Dressings; the record does not assign those events to the MediHoney or standard-care arm. The figures therefore cannot be used to make an arm-to-arm safety comparison or to attribute events to the intervention.
The trial's randomized design describes the intended comparison, but randomization by itself does not provide a result. An analyzed comparison requires outcome data and an appropriate analysis. Since the registry identifies the absence of an analysis as the reason data are unavailable, the record supports describing the design and its missing results, not drawing a conclusion about the relative outcome of the two wound-care approaches.
9. Statistical Methods Explained
The registry describes a randomized, open-label, parallel-group design. Randomization is intended, in general, to make treatment groups comparable at the point of assignment by using chance rather than clinical judgment to allocate participants. It can reduce systematic differences between groups, especially when allocation is properly implemented. It does not guarantee that groups will look alike in a small trial, and it cannot compensate for missing outcome data. The record does not explain the randomization sequence or allocation concealment.
What does open-label mean?
Open-label means that masking was not used. In general, knowing which care was assigned can influence participant behavior, care delivery, outcome assessment, or decisions about whether an event has occurred. For an endpoint involving an exit-site infection, consistent definitions and assessment procedures can be important. The registry does not describe infection criteria, assessor masking, or procedures intended to limit assessment differences.
How should time to event be understood?
Time to first exit-site infection is a time-to-event endpoint. In general, analyses of this type account for both event occurrence and event timing. A participant with no recorded infection by the end of observed follow-up has an event time that is not known; such follow-up is commonly treated as censored. Valid interpretation depends on knowing when follow-up ended and why. The registry does not report event times, censoring information, a survival curve, or a model-based estimate.
Different methods can be used for time-to-event data, depending on the question and assumptions. A general comparison may focus on the pattern of event-free time, while a hazard model may compare event rates over follow-up under additional assumptions. These are examples of statistical approaches, not methods identified as used in this trial. The registry does not report which method was planned or performed. It would therefore be inappropriate to name a particular analysis as the trial's method.
What do uncertainty measures contribute?
In general, an effect estimate describes the size and direction of a comparison, while a confidence interval conveys its statistical uncertainty. A p-value, when used, assesses compatibility between data and a specified null hypothesis under the chosen analysis; it is not a measure of clinical importance. None of these primary-outcome results is reported in the registry. The absence of an estimate means there is no basis for evaluating either the size or precision of a possible effect.
What are the planning calculations?
General sample-size calculations illustrate how many participants or events might be needed under chosen assumptions. The registry's stated planning framework uses a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is described as a fraction of an observed effect. For time-to-event calculations, the stated convention is to express the total number of events using the Schoenfeld approach; other calculations express participants per arm. Such illustrations are not observed power and are not a substitute for an analyzed treatment effect. They should be understood as planning scenarios, not evidence that the study achieved a particular level of power or precision.
Over-dispersion is a general concern when observed variation exceeds what a statistical model assumes. In count or rate data, ignoring excess variation can make standard errors too small and confidence intervals too narrow. This trial's primary outcome is time to first infection, and the registry does not report a count model or an over-dispersion assessment. The concept is relevant to statistical interpretation generally but cannot be connected to an analysis reported for this trial.
The essential distinction is between a design and a completed analysis. The design identifies the intended comparison and endpoint. The registry states that no analysis occurred and does not report an analysis method or primary-outcome results. Accordingly, methodological discussion can explain general principles, but it cannot establish which model was used or what conclusion an analysis would have produced.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study makes several statistical comparisons or tests multiple outcomes. In general, repeated testing can increase the chance of a false-positive finding unless the analysis plan accounts for it. The registry lists one outcome measure and reports zero analyses. It does not report a multiplicity strategy, such as a hierarchy of outcomes or an adjustment to significance thresholds. No interim analysis plan is reported, and none should be inferred from the registry.
The main issue for interpretation is missing outcome analysis rather than an excess of reported tests. The registry explicitly says that primary-outcome data were unavailable because no analysis occurred after communication between the surgical and research departments was lost. It does not report the number of participants with outcome follow-up, infection status, event times, or reasons for any participant-level missingness.
In general, missing outcome information can affect both the precision and validity of a comparison. The impact depends on how much information is missing and why it is missing, as well as the analysis assumptions. Those details are not reported in the registry record. There is no reported imputation, sensitivity analysis, or other method for addressing missing outcome data.
The registry also does not identify an analysis population, such as all randomized participants or only participants with observed follow-up. It gives no arm-specific outcome population counts. Without these details and without the endpoint analysis, the effect of exclusions or missing follow-up cannot be assessed.
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 |
|---|---|---|---|
| Surgical Catheter Dressings | 2 | 13 | 15.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Surgical Catheter Dressings | 2 of 13 |
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 |
|---|---|
| Surgical Catheter Dressings | 0 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Surgical Catheter Dressings |
|---|---|---|
| Perforated bowel | Gastrointestinal disorders | 1 of 13 |
| Yeast Infection | Gastrointestinal disorders | 1 of 13 |
Serious events with the highest arm-level rate: perforated bowel (7.7%), yeast infection (7.7%).
The registry lists a safety group titled Surgical Catheter Dressings, with 13 participants at risk for serious adverse events and 2 affected. It records 13 at risk for other adverse events and 0 affected, and lists 2 deaths. The serious adverse terms shown are Perforated bowel and Yeast Infection, each listed as 7.7%.
These are descriptive registry figures. The record does not specify whether the serious events or deaths occurred in the MediHoney arm, the standard-care arm, or both. It does not report event timing, individual-level overlap, causes of death, or whether any event was judged related to the intervention. The safety group label alone does not support assigning events to a treatment group.
The figures should not be read as a comparative safety analysis. The registry does not provide arm-specific denominators or a statistical comparison of adverse events. In general, observed event counts describe what was recorded in the observed group; they do not by themselves establish causation or the rate expected in a broader population.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, open-label trial was planned to compare MediHoney wound care with standard care after catheter implantation. It specifies time to first exit-site infection as the primary endpoint and records enrollment of 13 participants. It also records that the study was terminated after communication between the surgical and research departments was lost.
The record does not establish whether MediHoney changed time to infection. No primary-outcome analysis, effect estimate, confidence interval, or p-value is reported. There is no result from which to assess the direction, size, or precision of a treatment difference. The presence of a planned randomized comparison is not itself evidence of benefit or harm.
The listed serious adverse events, other adverse events, and deaths are not presented by randomized arm. They cannot show that one approach had more or fewer events than the other, and the registry does not report whether events were considered related to treatment. They should be read as recorded safety counts with limited context.
In general, an inconclusive record is not equivalent to evidence that two approaches have the same effect. Establishing similarity or excluding an important difference requires an analysis with enough information and an appropriate uncertainty assessment. Neither is available for the primary endpoint in this record. The defensible interpretation is that the intended question remains unanswered by the posted results.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between registering a clinical question and answering it with analyzed outcome data. The record contains a randomized parallel-group design, a defined primary time-to-event outcome, and safety counts, but no analysis of the primary endpoint. Without that analysis, the planned comparison cannot yield an estimate of how the groups differed.
Randomization is valuable because it provides a framework for a fair comparison, but its value depends on retaining and analyzing outcome information. When a study ends without an outcome analysis, the design cannot support a treatment-effect conclusion. Enrollment alone does not reveal whether the study could distinguish an effect from chance variation, nor how precise any estimate would have been.
The record also demonstrates why endpoint details and analysis populations matter. Time to first infection requires information about event timing and follow-up, while interpretation of safety counts requires clarity about treatment-arm attribution. Neither kind of detail is sufficient to recover the missing primary comparison.
Finally, study termination and the stated loss of communication between departments are part of the context for interpreting the record. They explain why the registry says no analysis occurred; they do not supply an alternative statistical result. Transparent reporting of that limitation helps readers separate the trial's intended question from what its posted data can establish.
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 is that the registry reports no analysis of the primary outcome and says the data were unavailable. Consequently, there are no arm-specific infection counts, event times, follow-up summaries, effect estimates, confidence intervals, or p-values. The central efficacy question cannot be evaluated statistically from the posted results.
The recorded enrollment is 13, but the number assigned to each arm and the number contributing outcome data are not reported. The registry does not provide participant characteristics, the randomization method, allocation concealment, infection definitions, or details of follow-up. These omissions prevent assessment of group comparability, outcome ascertainment, and the potential consequences of missing data.
The study is recorded as terminated because communication between the surgical and research departments was lost. The record does not explain the timing or operational details of that loss, or whether any follow-up continued. It also does not report a protocol-level statistical analysis plan, sample-size justification, interim analyses, or a missing-data strategy.
Safety information is limited to a combined group label and counts. The record does not show how those events were distributed across treatment arms, whether they were related to the intervention, or whether adverse events overlapped with deaths. These limitations mean that neither comparative efficacy nor comparative safety can be determined from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing — NCT01230489.
- Registry record last updated 2018-08-17; status last verified 2018-03.
- Results first posted 2018-08-17.
- 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
NCT01230489 is a randomized, open-label, parallel-group trial of MediHoney versus standard care for postoperative catheter exit sites in people with renal failure. Its primary endpoint was time from catheter implantation to first exit-site infection, up to two years or the first infection, whichever came first.
The registry records enrollment of 13, a start in 2011-01, primary completion on 2016-11-28, and terminated status. It states that no analysis occurred because communication between the surgical and research departments was lost. Therefore, the posted record contains no comparative primary-outcome result. Safety counts are listed for Surgical Catheter Dressings without treatment-arm attribution.