PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions (NCT05773781), a randomized na study. The primary outcome is Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1.

2. Clinical Question

3. Trial Design

This was a randomized, double-masked, parallel-group trial sponsored by the University of Liverpool. The registry lists an enrollment of 73 and a completed status. The intervention was PuraBond® application to the surgical field during transoral resection; the comparator was the same surgery without PuraBond® application. The registry lists phase as not applicable. The study start date was 2023-10-16, and primary completion was 2024-08-30.

Random allocation is intended to create groups that are comparable on average, including with respect to measured and unmeasured characteristics. In a parallel-group design, participants remain assigned to one group rather than crossing between treatments. Double masking indicates that two groups of study personnel or participants were intended to be unaware of assignment, but the registry record does not specify which parties were masked or how masking was implemented.

The posted primary outcome summaries include 31 participants in the PuraBond® group and 33 in the group without PuraBond®. Secondary hemorrhage and return-to-theatre results use denominators of 32 and 36, while the serious adverse event summaries also use 32 and 36 participants at risk. Those differing denominators mean that the posted outcome summaries do not all describe exactly the same number of participants. Reasons for those differences and the analysis populations are not reported in the registry record.

The registry describes a primary pain outcome and lists other postoperative complications and recovery outcomes. It records 17 outcome measures, with 8 secondary outcomes posted. The original sample-size justification, detailed protocol, eligibility criteria, and planned analysis populations are not reported in the registry record. The enrollment total should therefore be read as the number recorded as enrolled, not as the denominator for every posted outcome.

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

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1, measured over Baseline and day 7.

The primary endpoint is change from baseline in cumulative pain on the visual analogue scale at postoperative week 1. Its timeframe is recorded as baseline and day 7. The scale runs from 0, meaning no pain, to 10, meaning worst pain. The outcome is continuous: each participant’s score can take a range of values, and the posted group summaries are means with standard deviations.

Change from baseline is used to represent how a measured outcome differs from its starting level over the study period. In general, comparing change scores can focus attention on the postoperative course while accounting for the baseline measurement. The registry record does not state the exact calculation convention for change, including whether the reported value is baseline minus day 7 or day 7 minus baseline. Interpretation of the direction of a change score should therefore not assume an unstated sign convention.

Pain is measured on a scale with an explicit lower and upper meaning, which makes the clinical direction of the raw VAS score understandable: higher scores represent more pain. The primary result compares the group means, but a mean difference alone does not describe how individual scores were distributed. Standard deviations give information about variability among participants, while a confidence interval around the group contrast expresses uncertainty about the estimated mean difference. The registry record does not report a threshold for a clinically important difference.

A week-1 measure provides a defined early postoperative assessment. It does not by itself describe pain throughout the full 30-day period mentioned in the trial summary, nor does it establish the pattern of pain at every intervening time.

7. Results Posted in the Registry

• No PuraBond®: mean 4.35 versus 3.27 on control; difference 1.08 (95% CI -0.30 to 2.46), standardized effect d = 0.38; z-test p = 0.126.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Secondary Haemorrhage

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • No PuraBond®: 16.7% (6/36) versus 6.2% (2/32) on control; risk difference 10.4 percentage points (95% CI -4.4 to 25.2), risk ratio 2.67 (0.58–12.29); unadjusted two-proportion z-test p = 0.183.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between No PuraBond® and the control. The interval gives the range of effects that remain compatible with the data.

Secondary Return to Theatre

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • No PuraBond®: 2.8% (1/36) versus 3.1% (1/32) on control; risk difference -0.3 percentage points (95% CI -8.4 to 7.7), risk ratio 0.89 (0.06–13.64); unadjusted two-proportion z-test p = 0.933.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between No PuraBond® and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover postoperative complications and recovery, including hemorrhage, return to theatre, readmission, length of stay, oral feeding, and analgesia use. The record lists 8 secondary outcomes as posted, while the study summary describes a broader set of postoperative measures. The registry record does not report results for every listed secondary outcome in the information analyzed here, so the available secondary results cannot be treated as a complete account of all recovery outcomes.

Across the posted secondary comparisons, the outcome data are sparse in several categories. For rare events, a small number of participants can have a large influence on the estimated group contrast, and confidence intervals can remain broad even when the point estimates differ. For outcomes with counts close between groups, the data may likewise be too limited to distinguish a modest effect from no difference. The comparison results should be read together with their event counts and intervals, rather than as definitive evidence based only on the p-value.

The secondary results complement the primary pain outcome but do not replace it. The primary endpoint addresses week-1 change in pain; secondary endpoints address particular complications and aspects of postoperative recovery. Similarity or difference in one secondary outcome does not establish the primary result, and a pattern across distinct outcomes does not automatically amount to a single overall treatment effect. They measure different aspects of the postoperative course and can have different denominators and statistical properties.

Unadjusted secondary results carry less weight because multiple outcomes and comparisons create opportunities for chance findings. The registry record does not report a multiplicity adjustment or a prespecified hierarchy among secondary outcomes. Accordingly, an isolated secondary p-value should be considered exploratory unless the protocol or analysis plan establishes otherwise. The full protocol and detailed analysis plan are not reported in the registry record.

In general, secondary outcomes can help describe whether observed patterns extend beyond the primary measure, but sparse events, multiple testing, and incomplete outcome reporting limit how much they add to the main inference. They are best treated as context for the trial’s postoperative profile, not as independent confirmation of a primary conclusion.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Readmission
• Primary Haemorrhage
• Secondary Haemorrhage
• LOS
• Primary Return to Theatre
• Secondary Return to Theatre
• Oral Feeding
• Analgesia Use

9. Statistical Interpretation

10. Statistical Methods Explained

For the primary continuous outcome, the posted results give a mean and standard deviation for each group, then a mean difference comparing the group without PuraBond® with the PuraBond® group. The reported difference is 1.08 points. A mean difference retains the scale’s units, so it can be interpreted in VAS score points rather than as an abstract standardized quantity. The registry record does not state whether the comparison was adjusted for baseline score or other characteristics.

What does a mean difference describe?

A group mean is the arithmetic average of participants’ scores in that group. The mean difference subtracts one group mean from the other according to a defined contrast. Here, the contrast is no PuraBond® minus PuraBond®. A positive estimate therefore means the posted mean is higher in the no-PuraBond® group; a negative estimate would mean it is lower. Because the scale identifies higher raw VAS values with worse pain, this direction can be understood for the score itself. However, the endpoint is a change score and the registry record does not report the sign convention used to calculate change. That limits interpretation of the clinical direction of the change-score contrast.

The standard deviation describes how much participant scores vary around the mean within a group. It is not the uncertainty interval for the group mean and it is not the standard error of the difference. Standard deviations of 2.75 and 2.9 indicate that individual outcomes were spread around their group averages. In general, a large spread relative to a mean difference makes it harder to estimate a precise group contrast from a given sample. The standard deviation does not reveal the distribution’s shape or whether a small number of observations strongly influence the mean.

How should the p-value be read?

The posted unadjusted p-value for the primary comparison is 0.126. In general, a p-value evaluates how unusual results at least as incompatible with a null hypothesis would be if that null model and the test assumptions were correct. It does not measure the probability that the null hypothesis is true, and it does not quantify the size or clinical importance of an effect. The registry record does not report the named statistical test, the full model specification, or adjustments to the primary comparison.

“Unadjusted” means that the reported comparison is not described as adjusted for multiple testing. It should not be read as a baseline-adjusted estimate: whether the primary result was adjusted for baseline or other covariates is not reported in the registry record. A p-value is most informative alongside an effect estimate and confidence interval. A result can have a p-value that does not meet a conventional threshold while still being compatible with a range of potentially relevant effects.

Why do confidence intervals matter?

A confidence interval gives a range of values compatible with the data and the statistical procedure, under its assumptions. It conveys uncertainty about the estimated contrast, not the range of individual participants’ scores. For the primary comparison, the interval crosses zero. Zero represents no difference in the group means under the stated contrast. Because the interval includes values below and above zero, the posted result does not rule out either direction. The exact interval endpoints are not repeated in this explanation because the registry values are reported at greater than three decimal places.

In general, an interval that is wide relative to the scale of interest signals limited precision. Precision depends on factors such as sample size, variability, and the analysis method. The relatively small outcome denominators and the observed spread are relevant to precision, but the registry record does not report a formal power calculation for the original design. A confidence interval should not be treated as a guarantee that the true effect lies within its endpoints; its interpretation depends on the sampling and model assumptions.

What does randomization contribute?

Random assignment is designed to reduce systematic differences between treatment groups at the start of a study. In expectation, it balances both known and unknown prognostic factors, although chance imbalances remain possible, particularly in a trial with modest group sizes. Randomization does not ensure that every participant contributes outcome data, prevent measurement error, or resolve problems caused by missing observations. Allocation concealment procedures and the sequence-generation method are not reported in the registry record.

Masking can reduce the influence of expectations on care, outcome reporting, and assessment. The study is labeled double-masked, but the record does not identify exactly who was masked or describe how the intervention’s application was concealed. The outcome is based on a pain scale, making clear reporting of participant masking and measurement procedures relevant to interpretation.

What does the planning illustration represent?

The planning figures use the observed effect as a reference and calculate participants per arm under a two-sided significance level of 0.05, equal allocation between the groups, and a normal approximation. These are planning illustrations, not a report of the original trial’s design assumptions. For the continuous primary comparison, the illustration gives 108 participants per arm to target 80% power when planning for 100% of the observed effect; planning for 75% gives 192 per arm, and planning for 50% gives 431 per arm. These estimates do not alter the uncertainty in the observed trial result.

Power is the probability, under a specified assumed effect and statistical model, of detecting an effect at the chosen significance level. The 80% and 90% columns represent different target probabilities under those planning assumptions. In general, targeting higher power requires more participants when other assumptions are held fixed. Planning for a smaller effect also requires more participants because a smaller signal is harder to distinguish from random variation. A planning calculation based on the observed effect is sensitive to the instability of that observed estimate, especially when the trial is small.

The record lists 17 outcome measures and 8 posted secondary outcomes. A set of outcomes and comparisons can raise multiplicity concerns: the more unadjusted tests performed, the greater the chance of at least one apparently notable result under a broad null scenario. The registry record does not report a multiplicity strategy or the full set of planned comparisons. The posted p-values should therefore be interpreted in light of the possibility that they are among several examined outcomes, without assuming that any particular correction was or was not used.

11. Confidence Intervals and Precision

The primary mean difference is 1.08 VAS points, with the contrast defined as no PuraBond® minus PuraBond®. Its confidence interval spans zero, extending to values on both sides of no mean difference. This is a direct indication that the estimate is uncertain about direction as well as magnitude. The p-value of 0.126 is consistent with that uncertainty; neither statistic establishes that the groups are the same.

Precision concerns how narrowly the data estimate a quantity, not whether the estimate is clinically important. The observed group means were 3.27 and 4.35, and the standard deviations were 2.75 and 2.9. The outcome denominators were 31 and 33. With participant scores dispersed around the means and relatively few observations contributing to each group summary, a wide range of group differences can remain compatible with the result. The registry record does not give a clinically important difference threshold, so the interval cannot be classified against such a benchmark.

The confidence interval describes uncertainty in a group-level contrast, not the range in which individual pain scores fall. It also does not incorporate uncertainty arising from all possible sources of bias, such as missing outcomes, measurement procedures, or departures from the planned analysis. The registry record does not report the missing-data strategy, analysis population, or detailed model assumptions, so the confidence interval should be interpreted as conditional on the method used to generate it.

In general, confidence intervals are more informative than a binary significant/not-significant label because they show which effect sizes are compatible with the data under the analysis assumptions. Here, the interval crossing zero means that the posted data do not sharply distinguish a positive contrast from no contrast or a negative contrast. More precise evidence would require more information or a study designed to estimate the contrast with a narrower interval; the registry record does not provide a target precision or a protocol-based sample-size justification.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for the continuous primary outcome and the posted binary outcomes. They are not total event counts. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect is the stated fraction of the observed effect. For time-to-event outcomes, planning figures would instead be total events, but the posted planning illustrations described for these outcomes are not time-to-event calculations.

The 80% power column gives the number of participants per arm estimated to provide an 80% chance of detecting the assumed effect under those planning assumptions. The 90% power column uses a higher target chance of detecting that same assumed effect, so it generally calls for more participants. These are planning targets, not guarantees about what a future study will achieve. The figures do not show the probability that the completed trial detected an effect.

For the primary outcome, planning for 100% of the observed effect gives 108 participants per arm for 80% power and 145 per arm for 90% power. Planning for 75% of the observed effect gives 192 and 257 participants per arm, respectively; planning for 50% gives 431 and 577. The pattern illustrates a general principle: smaller effects are harder to distinguish from random variation, so more participants are needed when the effect of interest is smaller. The curve follows the same planning logic as the listed figures, with required sample size increasing as the assumed effect decreases.

These values are calculated from the observed effect, not from the trial’s original design. The original sample-size justification and its assumptions are not reported in the registry record. The planning figures are not observed power: they are prospective illustrations under stated assumptions, and they should not be used to reinterpret the observed p-value as a probability that the trial “had enough power.”

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 1.080; pooled standard deviation σ = 2.828.
2. n = 2 × (1.96 + 0.842)² × 2.828² / 1.080² = 107.7, rounded up to 108 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.08                      # observed difference in means
sigma <- 2.82841286852516                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5773781)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 108 (80% power), 145 (90% power)
 75% of observed effect: n per arm = 192 (80% power), 257 (90% power)
 50% of observed effect: n per arm = 431 (80% power), 577 (90% power)
power.t.test: 108.6 
Simulated power at n = 108 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists 17 outcome measures and 8 posted secondary outcomes. Testing several outcomes increases the chance of at least one result appearing unusual by chance when each comparison is considered separately. Multiplicity can be addressed through a prespecified hierarchy, adjustment of significance thresholds, or other methods, but the registry record does not report whether any such approach was planned or used. It also does not report which outcome comparisons were prespecified as confirmatory and which were exploratory.

The reported p-values are unadjusted. They should therefore not be interpreted as if a multiplicity procedure had been applied. At the same time, the record does not provide enough information to reconstruct the full family of planned tests or determine what an appropriate correction would have been. The original protocol and statistical analysis plan are not reported in the registry record.

Outcome denominators differ across the posted results. The primary endpoint includes 31 participants in the PuraBond® arm and 33 in the no-PuraBond® arm, while the posted secondary outcome and safety summaries include 32 and 36. The registry record does not explain those differences, identify reasons for missing observations, or state whether all randomized participants were included in each analysis. It does not report imputation, sensitivity analyses, or other methods for handling missing data.

The analysis population is also not reported in the registry record. In general, an intention-to-treat analysis retains participants in their randomized groups, while a per-protocol analysis applies specified adherence or eligibility criteria; these approaches answer related but not identical questions. The record does not state which approach was used for the posted outcomes, so no label should be assumed.

Interim analyses, stopping rules, and any adjustments associated with repeated examination of accumulating data are not reported in the registry record. These omissions do not establish that such procedures were or were not used. They limit the ability to assess how the posted estimates and p-values relate to the trial’s original analysis plan.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: haemorrhage (3.1%), cerebral infarct (2.8%).

The registry’s serious adverse event summary lists 32 participants at risk in the PuraBond® group, with 1 affected, and 36 at risk in the group without PuraBond®, with 3 affected. Deaths are recorded as 0 in each group. The separate other-adverse-event summary lists 6 affected participants among 32 at risk in the PuraBond® group and 7 among 36 at risk in the no-PuraBond® group.

The registry also lists Haemorrhage at 3.1% and Cerebral infarct at 2.8% among the top serious adverse event terms. The record does not establish from these figures alone how those terms were distributed by randomized group. The serious and other adverse event counts are descriptive counts, not adjusted comparisons. They do not show whether an event was caused by the intervention, and the registry record does not report event-level timing, severity details, or a formal comparative safety analysis.

Safety denominators differ from the primary pain outcome denominators. The record does not explain the difference, so the counts should be interpreted using the stated number at risk for each safety summary rather than the enrolled total. With these group sizes and event counts, the figures describe reported events but provide limited precision for comparing uncommon outcomes.

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

The posted result is an estimate of the difference in mean week-1 change scores between randomized groups, accompanied by uncertainty. The mean was 3.27 in the PuraBond® group and 4.35 in the group without PuraBond®, with a reported contrast of 1.08 points for no PuraBond® minus PuraBond®. The confidence interval includes zero, and the unadjusted p-value is 0.126. Together, these statistics show that the observed data do not determine a clear direction or precise magnitude for the underlying group difference.

This does not demonstrate that the groups are equivalent, nor does it prove that there is no difference. A nonsignificant p-value can arise when the true effect is small, when the data are variable, when sample sizes are limited, or through combinations of these factors. The confidence interval’s span across zero is the more direct reminder that both a difference and no difference remain compatible with the posted result under the analysis assumptions. An equivalence conclusion would require a prespecified margin and an appropriate analysis; neither is reported in the registry record.

Nor does the point estimate alone establish that PuraBond® caused a reduction in pain. Randomization is a strength for estimating group effects, but interpretation also depends on which participants were analyzed, how missing outcomes were handled, how change was calculated, and what statistical model was used. Those details are not reported in the registry record. The outcome is also a mean, which does not describe the experience of every participant or show whether individual responses varied in clinically important ways.

The trial’s secondary and safety summaries add descriptive information about complications and recovery, but their limited event counts, multiple comparisons, and lack of a reported multiplicity plan constrain their inferential weight. They cannot substitute for the primary pain comparison or resolve its uncertainty. The registry record does not report a clinical importance threshold for the pain scale result.

The appropriate statistical conclusion is limited: the posted summaries estimate a group difference, but the estimate is imprecise and compatible with effects in either direction. These results are not a treatment recommendation, and they should not be generalized beyond the population and procedures represented by the trial without further evidence.

17. Why This Trial Matters Statistically

This trial raises a common statistical challenge in perioperative research: a clinically intuitive question may be evaluated through a continuous patient-reported outcome while the study also tracks relatively uncommon complications. Pain scores and event counts provide different kinds of evidence. A mean comparison uses the full range of scale values but can be affected by variability and by how change is defined. Rare-event comparisons can be dominated by a small number of observations and yield wide uncertainty.

The primary estimate illustrates why a p-value alone is not an adequate summary. The reported difference is 1.08 points, while the confidence interval crosses zero and the p-value is 0.126. The estimate’s direction, precision, and scale context all matter. A conclusion based only on whether a p-value passes a threshold would hide the range of effects compatible with the data and could incorrectly suggest that a nonsignificant result proves no difference.

The sample-size illustrations also demonstrate how planning depends on the effect researchers aim to detect. Calculations based on the observed effect can be useful for showing how required enrollment changes under different assumptions, but they are not substitutes for a prospectively justified design. The original design assumptions are not reported in the registry record, so the planning calculations cannot establish whether the trial was designed to answer its primary question with a particular precision.

Finally, differences in denominators and the absence of reported details on missing data, analysis populations, and multiplicity matter for transparent interpretation. Those features are not peripheral: they determine how closely the posted comparisons reflect the randomized groups and how confidently secondary findings can be read. This record is a useful example of separating the numerical result from the strength of the inference that can be drawn from it.

18. 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 primary pain comparison includes 31 and 33 participants, while 73 participants were enrolled. The registry record does not explain why the primary outcome denominators differ from enrollment, or why the secondary and safety summaries use denominators of 32 and 36. Without reasons for missing outcomes and a stated analysis population, it is difficult to assess whether the posted comparisons preserve the benefits of randomization.

The registry identifies the primary endpoint as change from baseline but does not state the sign convention for calculating change. It also does not report whether the comparison was adjusted for baseline pain, how the statistical model was specified, or which test generated the unadjusted p-value. The outcome is a bounded VAS score, but participant-level data and distributional summaries are not reported, so the influence of skewness, outliers, or ceiling and floor patterns cannot be assessed.

The original sample-size justification, detailed statistical analysis plan, and any clinically important difference threshold are not reported in the registry record. The planning illustrations based on the observed effect do not fill that gap. The number of listed outcomes and posted secondary outcomes raises the possibility of multiple testing, but the registry record does not identify a testing hierarchy or adjustment strategy. Results from secondary comparisons therefore require particular caution.

The record describes the study as double-masked but does not specify who was masked or how masking was maintained. It does not provide details on allocation concealment, outcome assessment procedures, adherence, protocol deviations, or interim analyses. These matters may affect interpretation, but their status cannot be inferred from the registry summary.

Finally, the posted summaries do not provide detailed outcome results for every listed secondary measure. The available data therefore offer only a partial account of recovery and complications. These limitations restrict the strength and scope of statistical conclusions; they do not by themselves establish that the trial was conducted incorrectly.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions — NCT05773781.
• Registry record last updated 2025-09-16; status last verified 2024-11.
• Results first posted 2025-09-16.
• 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.

22. Record Summary

NCT05773781 is a completed randomized, double-masked, parallel-group trial sponsored by the University of Liverpool. It enrolled 73 participants undergoing transoral resection of primary oral or oropharyngeal mucosal lesions. The comparison was surgery with PuraBond® application to the surgical field versus surgery without its application.

The primary outcome was change from baseline in cumulative VAS pain at postoperative week 1, with the scale running from 0, no pain, to 10, worst pain. Posted means were 3.27 for PuraBond® and 4.35 for no PuraBond®, with a mean difference of 1.08 and an unadjusted p-value of 0.126. The confidence interval includes zero, indicating substantial uncertainty about the direction and size of the group difference.

The registry lists 17 outcome measures and posts 8 secondary outcomes. It also provides adverse event counts. The original sample-size justification, detailed analysis plan, missing-data methods, and analysis populations are not reported in the registry record.