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 Evaluation of a Novel Sutureless Drain Securement Device (NCT05251753), a randomized na study. The primary outcome is Time it Takes to Secure and Dress Each Drain in Totality.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05251753 |
| Phase | NA |
| Condition | Skin Injury |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
The registry record concerns drain securement on the day of surgery. The condition listed is Skin Injury, and the outcome description refers to securing and dressing each drain. Eligibility criteria and further details about the participant population are not reported in the registry record.
Intervention
The intervention is K-Lock, an investigational sutureless drain securement device. The record describes one arm as K-Lock on the left side with suture-based securement on the right, and the other as K-Lock on the right with suture-based securement on the left.
Comparator
The comparator is standard suture-based drain securement. The record frames the comparison as K-Lock versus the standard technique, but does not provide additional procedural details about the comparator.
Primary question
The primary outcome is the time, in seconds, required to secure and dress each drain in totality on the day of surgery. The stated purpose is to assess feasibility. The registry record does not report the observed times, a comparison estimate, or an inferential analysis, so it does not establish how the techniques compare on this outcome.
3. Trial Design
The study is listed as randomized, with no masking and a parallel model. The intervention is a device study, and the registry record gives an enrollment of 22. The study status is completed. The recorded start date is 2022-03-07, and the primary completion date is 2025-03-06. The listed phase is NA.
The arm descriptions specify K-Lock on one side and suture-based securement on the other, with the K-Lock side reversed between the two arms. At the same time, the registry model is listed as parallel. How the side-specific descriptions relate to participant-level allocation and analysis is not reported in the registry record. In particular, the record does not explain whether outcomes from opposite sides of the same participant were handled as paired observations or whether the primary comparison was analyzed as independent groups. That distinction matters because observations from sides of the same person may not be statistically independent.
The listed sponsor is Wake Forest University Health Sciences. Skin Injury is the listed condition. Ease of Use and Skin Injury are listed as secondary outcomes, while the primary outcome is time to secure and dress each drain in totality. The record names K-Lock as the intervention and describes the comparator as a standard suture-based technique.
Although the study is marked completed, the registry record does not report the primary-outcome results or a statistical analysis of them. Completion status alone does not indicate what was observed, how the observations were analyzed, or whether the results support a difference between techniques.
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 | A K-Lock Left | B K-Lock Right |
|---|---|---|
| STARTED | 13 | 9 |
| COMPLETED | 13 | 9 |
| NOT COMPLETED | 0 | 0 |
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 | A K-Lock Left | B K-Lock Right | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 9 | 22 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 13 | 9 | 22 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 45.30769231 (SD 8.606050346) | 42.77777778 (SD 15.03144851) | 44.27272727 (SD 11.40251358) |
| Sex: Female, Male: Female | Participants | 12 | 9 | 21 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): White | Participants | 11 | 8 | 19 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 13 | 9 | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Time it Takes to Secure and Dress Each Drain in Totality, measured over Day of Surgery.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Seconds |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the time required to secure and dress each drain in totality, measured in seconds on the day of surgery. The description says that video recordings were evaluated to identify timestamps and that the results were documented on a study outcomes tool. The intended purpose was to assess feasibility of using K-Lock.
This is a continuous outcome: elapsed time can take a range of values rather than representing a category or event count. The registry specifies a mean as the summary measure and a standard deviation as the measure of dispersion. A mean describes the average time, while a standard deviation describes how spread out individual times are around that average. These summaries can help describe both typical procedure duration and variability, but do not by themselves establish whether any difference between techniques is statistically persuasive or practically important.
The record does not report the observed means, standard deviations, or a direct comparison. It also notes that the primary outcome has several categories or time points and was not reduced to a single comparison. The specific categories or time points, and how they relate to the endpoint description, are not reported in the registry record. As a result, the intended measure is identifiable, but the posted information does not permit interpretation of the outcome’s observed magnitude or precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of K-Lock with standard suture-based drain securement and names time to secure and dress each drain as the primary outcome. However, the registry record does not report the observed primary-outcome values or an analysis comparing the techniques. There is therefore no reported estimate of the difference in time, no uncertainty interval for that comparison, and no reported test result to interpret.
The record describes the primary measure as a mean with standard deviation. Those statistics would describe the distribution of measured times within groups. A treatment comparison would require a clearly defined contrast between groups, along with an estimate and an account of its uncertainty. The posted record supplies neither. The mean and standard deviation are analysis specifications, not outcome findings.
The study is marked completed, but completion is not evidence of a particular result. Nor does the registry record establish that the device required less time, more time, or similar time compared with the suture-based technique. It also does not report results for Ease of Use or Skin Injury as secondary outcomes. A reader should not infer efficacy, feasibility, or equivalence from the study status or from the fact that an endpoint was planned.
The arm descriptions place K-Lock and suture-based securement on opposite sides, with the K-Lock side reversed by arm. The registry also lists a parallel model. The handling of side-level measurements, and whether the comparison accounted for within-participant dependence, is not reported in the registry record. This is important because the appropriate uncertainty calculation can depend on whether measurements are independent or paired.
There are adverse-event counts, but these are not a substitute for the primary endpoint or for a full safety analysis. The registry reports zero serious adverse events in each arm’s listed at-risk group and one other adverse event in each. The time period for adverse-event collection, event descriptions, and analysis methods are not reported in the registry record. These counts should be read as the posted registry figures, not as comprehensive evidence about risk.
Overall, the registry supports a description of the planned comparison and outcome, but not a conclusion about the observed comparative performance of the device. Without posted outcome estimates and their uncertainty, the size and precision of any difference remain unknown.
9. Statistical Methods Explained
The registry describes a randomized, non-masked study with a parallel model. Randomization is intended, in general, to reduce systematic differences between treatment groups by assigning participants according to a chance process. It does not guarantee that groups will be identical in every characteristic, especially in a small study. The record does not describe the randomization sequence, allocation concealment, or the method used to implement assignment.
What does the primary summary measure mean?
The primary outcome is continuous time in seconds. The registry specifies the mean and standard deviation. The mean is the arithmetic average of measured times. The standard deviation conveys how dispersed those times are around the mean. Neither measure alone describes the uncertainty in the difference between techniques. A comparison would ordinarily report a contrast, such as a difference in average time, together with an uncertainty measure. No such comparison is reported in the registry record.
General statistical interpretation: a confidence interval expresses a range of values compatible with the observed data under a specified statistical model. Its width reflects precision; a wider interval indicates less precise estimation than a narrower interval. A confidence interval is not reported for the primary comparison in the registry record, so the precision of any treatment contrast cannot be assessed from the posted information.
Why does the analysis unit matter?
The arm descriptions refer to K-Lock and suture-based securement on opposite sides, while the study model is listed as parallel. If measurements from two sides of the same participant were compared, they could be correlated. In general, accounting for that within-participant relationship can improve the validity of uncertainty estimates. Treating correlated observations as independent can produce inappropriate standard errors and confidence intervals. The registry record does not report whether the primary analysis treated observations as paired, independent, or in another way, and does not clarify the analysis unit.
What does the registry say about planning calculations?
The stated planning assumptions describe an illustration based on the observed effect, a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The planning description says that the effect to detect is a stated fraction of the observed effect. It also distinguishes time-to-event calculations, which use total events, from other calculations, which use participants per arm. These assumptions describe planning illustrations, not observed power and not necessarily the trial’s original design. The registry record does not report the trial’s own sample-size justification, and no numeric planning results are included in the record analyzed.
More generally, planning calculations depend on assumptions about the effect to detect, outcome variability, error rates, allocation, and the analysis model. If an effect estimate comes from a small study, it may be unstable. A planning illustration based on an observed effect should therefore not be read as proof that a future study will have a particular probability of detecting an effect. It is not a retrospective measure of whether this trial was adequately powered.
Why can variability affect a comparison?
Standard deviation describes participant-level variability in a continuous outcome. If the observed times vary widely, a group mean may be estimated less precisely than when times cluster more closely, all else being equal. In some outcome distributions, values may be asymmetric or contain unusually long times. General statistical methods may then need to account for the shape of the data or use a suitable alternative to a normal approximation. The registry record does not report the distribution of times, diagnostic checks, transformations, or alternative analyses.
Over-dispersion is a general issue for count outcomes, where observed variability exceeds what a simple model assumes. The primary endpoint is continuous time, not a count, and the record does not report an over-dispersion assessment. The more direct methodological concern raised by the arm descriptions is whether the side-level measurements were paired and analyzed accordingly.
The registry lists zero analyses. This means the registry record does not contain a reported analysis entry for the primary comparison. It does not establish whether analyses were conducted outside the registry. The statistical plan, model specification, covariate adjustment, handling of protocol deviations, and any interim analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and identifies Ease of Use and Skin Injury as secondary outcomes. It also states that the primary outcome has several categories or time points and was not reduced to one comparison. The specific categories or time points, and the number of comparisons associated with them, are not reported in the registry record. The registry lists zero analyses, so there is no posted set of outcome-specific estimates or tests to interpret.
When several outcomes, categories, or time points are examined, the chance of obtaining at least one apparently unusual result can increase if each is tested separately. General statistical approaches may address this multiplicity, for example by adjusting inference or by specifying a primary contrast in advance. The registry record does not report a multiplicity plan, a hierarchy among outcomes, or an adjustment method. It is therefore not possible to determine how any multiple comparisons were intended to be handled.
Missing-data methods and the number or pattern of missing primary-outcome observations are not reported in the registry record. The record does not specify whether observations were excluded, imputed, or analyzed under a particular assumption. The analysis population is also not reported: there is no stated description of which randomized participants or drain-level measurements were included in the analysis. These omissions matter because the handling of missing observations and the analysis population can affect both the estimated comparison and its uncertainty.
The registry does not report an interim-analysis plan, stopping boundaries, or a statistical analysis plan. None should be inferred from the study’s completed status or from its registry outcome descriptions.
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 |
|---|---|---|---|
| A K-Lock Left | 0 | 13 | 0.0% |
| B K-Lock Right | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| A K-Lock Left | 0 of 13 |
| B K-Lock Right | 0 of 9 |
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 |
|---|---|
| A K-Lock Left | 1 of 13 |
| B K-Lock Right | 1 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | A K-Lock Left | B K-Lock Right |
|---|---|---|---|
| Device became loose | Surgical and medical procedures | 1 of 13 | 0 of 9 |
| Hematoma | Surgical and medical procedures | 0 of 13 | 1 of 9 |
The registry reports serious adverse events for the listed groups. For A K-Lock Left, serious adverse events affected 0 of 13 at risk. For B K-Lock Right, serious adverse events affected 0 of 9 at risk. The record also lists one other adverse event in each group and zero deaths in each group. These figures describe the registry entries and should not be interpreted as a complete assessment of safety.
The record does not report the event descriptions for the other adverse events, the observation period, how events were defined or collected, or whether events were assessed for relatedness to the device or procedure. It also does not provide a statistical comparison of adverse-event frequency. Without those details, the counts cannot establish whether the groups differed in risk or whether all relevant events were captured.
The serious-event counts are small, and a count of zero does not prove that an event cannot occur. More generally, safety interpretation depends on the size and follow-up of the population, the consistency of event ascertainment, and the precision of estimates. Those details are not reported in the registry record. The figures should therefore be read narrowly as the posted serious-event counts, not as evidence of absence of harm.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to compare K-Lock, a sutureless drain securement device, with standard suture-based drain securement. It identifies a randomized allocation, a non-masked design, and time to secure and dress each drain as the primary outcome. It also gives the outcome unit, summary measure, and planned assessment time.
The posted record does not establish what the primary outcome showed. No observed times, group means, standard deviations, comparison estimate, confidence interval, or test result are reported. It is therefore not possible to conclude from the registry entry whether the techniques differed in time, how large any difference was, or how precisely it was estimated. The same limitation applies to the listed secondary outcomes, for which results are not reported.
The completed status does not fill this gap. A study can be completed without its results being entered in the registry record. Likewise, a stated purpose of assessing feasibility does not itself demonstrate feasibility. The registry record gives no basis for concluding that K-Lock is faster, slower, equivalent, or preferable on the primary endpoint.
The adverse-event counts are also limited: they describe the posted counts but lack event details, follow-up information, and a reported comparative analysis. The zero serious adverse events listed in each group should not be treated as proof that serious events are impossible or that the device has been established as safe.
In general, a treatment comparison is most informative when it includes an effect estimate and a measure of uncertainty, along with a clear account of the analysis population and methods. Those elements are not reported in the registry record. The appropriate interpretation is therefore that the study’s design and intended outcomes are described, while comparative results and their precision remain unreported.
13. Why This Trial Matters Statistically
This study raises a useful statistical issue: a seemingly straightforward time outcome can depend on the unit of analysis. The arm descriptions place the two securement techniques on opposite sides and reverse the K-Lock side between arms, while the model is listed as parallel. The registry does not explain whether the outcome data are participant-level, drain-level, or analyzed as paired side measurements. That distinction can affect the estimate of uncertainty and the validity of a comparison.
The endpoint is also operationally specific. Timing is based on video recordings and a documented study tool, rather than a subjective global judgment alone. The record describes the measurement approach, but does not report details such as timing rules, assessor training, or whether timing assessment was blinded. Because masking is listed as none, the possibility of awareness during the procedure or assessment is relevant to interpretation, although the consequences cannot be determined from the record.
The registry’s outcome description notes several categories or time points but does not provide a single comparison. This illustrates why specifying an outcome’s precise form and analysis contrast matters. Without a defined contrast and reported results, a continuous measure such as mean time cannot be interpreted comparatively.
Finally, the study is marked completed, yet the registry does not include a primary-outcome analysis. This distinction between a completed trial record and a complete results record is important for evidence appraisal. The design and intended measurement can be described, but the absent outcome estimates prevent assessment of effect size and precision.
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 central limitation is that the registry record does not report primary-outcome results or an analysis comparing K-Lock with suture-based securement. The mean and standard deviation are specified as summary measures, but their observed values are absent. No estimate of the comparative effect or its uncertainty is available.
Further design and analysis details are not reported in the registry record. Although the study is described as randomized and parallel, the arm descriptions assign K-Lock to opposite sides and place suture-based securement on the other side. The record does not clarify the relationship between sides, participants, and analysis units, or whether within-participant pairing was considered. Randomization procedures, allocation concealment, and the statistical model are also not described.
The primary outcome is noted as having several categories or time points, but the registry does not specify them or identify a single comparison. The analysis population, missing-data handling, multiplicity strategy, and statistical analysis plan are not reported. These omissions limit assessment of how the intended outcome was analyzed and how robust any possible result would be.
For safety, the record provides serious and other adverse-event counts but not event descriptions, collection period, ascertainment methods, or a comparative analysis. The listed counts consequently offer only a limited view of safety reporting.
The study is marked completed, but completion does not resolve the absence of posted results. The registry record does not report the trial’s own sample-size justification, interim analyses, or the details needed to evaluate those aspects. No conclusions about the magnitude, precision, or clinical importance of a comparative effect can be drawn from the available registry information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of a Novel Sutureless Drain Securement Device — NCT05251753.
- Registry record last updated 2025-05-20; status last verified 2025-01.
- Results first posted 2025-05-20.
- 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
NCT05251753, titled “Evaluation of a Novel Sutureless Drain Securement Device,” is a randomized, non-masked study with a parallel model and an enrollment of 22. It is listed as completed, with a start date of 2022-03-07 and a primary completion date of 2025-03-06. Wake Forest University Health Sciences is the listed sponsor.
The intervention is K-Lock, compared with standard suture-based drain securement. The primary outcome is time to secure and dress each drain in totality, measured in seconds on the day of surgery and summarized by a mean and standard deviation. Ease of Use and Skin Injury are listed as secondary outcomes.
The registry record does not report primary-outcome results or a comparative analysis. It lists zero analyses and notes that the primary outcome has several categories or time points and was not reduced to one comparison. Adverse-event counts are posted, but event details and the collection period are not reported.