SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects (NCT03762200), a na na study. The primary outcome is Haemostatic Success at 5 Minutes.

2. Clinical Question

The clinical question is about an observed endpoint after treatment, rather than a contrast between treatments. The record’s stated purpose is to evaluate safety and haemostatic effectiveness in the surgical settings it describes. It does not define a control group receiving another haemostatic approach, so the study cannot provide a direct randomized comparison with conventional methods or another device.

The endpoint is assessed at a specified time after application, but the registry record does not report the observed primary endpoint count or proportion. It therefore does not establish, from the posted information, how often the defined success criterion was met. Nor does it report a treatment-effect estimate against a comparator. Those distinctions matter: an endpoint question can be clearly stated even when the result needed to answer it is absent from the record.

3. Trial Design

NCT03762200 is a prospective, single-group, multicentre, multispecialty, post-market clinical study. The registry lists the study as completed, with an enrollment of 103. The sponsor is Ethicon, Inc. The recorded start date is 2018-11-26 and the primary completion date is 2019-12-02. The phase is listed as NA.

The intervention is SURGICEL Powder, classified as a device. The arm description states that qualified subjects were treated with SURGICEL Powder. The study concerns mild or moderate parenchymal or soft tissue bleeding during general, gynaecological, urological, and cardiothoracic surgery. The brief description includes open, laparoscopic, and thoracoscopic procedures, and describes use as an adjunct when conventional bleeding-control methods are impractical or ineffective.

There is no allocation to different treatment arms: allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. Thus, the recorded design has no concurrent control arm and is not a like-for-like comparison. Its results can describe outcomes among treated subjects, but the design does not isolate a treatment contrast from the other factors that may influence bleeding control or safety.

The Target Bleeding Site was to be assessed for haemostasis at 3, 5, and 10 minutes after application and before initiation of closure. The primary endpoint is haemostatic success at 5 minutes. The record also lists haemostatic success at 3 minutes and 10 minutes as secondary outcomes. Post-operative follow-up was planned through discharge and again at 30 days and 6 months after surgery by phone call or office visit. Whether follow-up was complete for all enrolled subjects is not reported in the registry record.

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: Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine or where plugging of the urethra, ureter or a catheter was possible by study product.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent to Treat (All subjects for whom TBS was identified)

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 Haemostatic Success at 5 Minutes, measured over From application of SURGICEL Powder to 5 minutes after application.

The primary endpoint is haemostatic success at 5 minutes after application of SURGICEL Powder. It is defined as the proportion of subjects with no detectable bleeding at the Target Bleeding Site and no rebleeding requiring additional treatment at that site at any time before initiation of final fascial closure. The stated timeframe runs from application through 5 minutes after application.

The endpoint is intended to capture a clinically interpretable event at the treated site: whether bleeding has been controlled under the study’s stated success definition at the specified assessment time, without subsequent rebleeding requiring additional treatment before closure. A binary endpoint records whether each subject meets that definition or does not. Reporting the number meeting the criterion alongside the number assessed would allow readers to understand both the observed frequency and the denominator to which it applies.

The registry record identifies the primary population as Intent to Treat, defined there as all subjects for whom a Target Bleeding Site was identified. It does not report the number in that population, the number achieving haemostatic success at 5 minutes, or the resulting proportion. Consequently, the endpoint definition is available, but its observed result cannot be described from the posted registry information.

Success at 3 minutes and 10 minutes is also listed as a secondary outcome. These assessments provide context about the time course of haemostasis, but their observed counts and proportions are not reported in the registry record either. The endpoint definition alone should not be mistaken for evidence about how often success occurred.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a binary primary outcome: subjects either meet the haemostatic-success definition or do not. For each subject, the definition combines haemostasis at the Target Bleeding Site at the 5-minute assessment with the absence of rebleeding requiring additional treatment before initiation of final fascial closure. A group-level proportion would ordinarily summarize how often this defined event occurred among subjects in the analysis population.

What would a confidence interval tell the reader?

In general, a confidence interval communicates the statistical uncertainty around an estimated quantity, such as a proportion. A narrower interval indicates greater precision under the assumptions of the method; a wider interval indicates more uncertainty. The interval does not capture every source of uncertainty, including possible measurement issues, selection effects, or limitations caused by having no comparator. No confidence interval for the primary endpoint is reported in the registry record, and the missing outcome count and denominator mean that the estimate itself cannot be reconstructed from the posted information.

What does a single-group design permit?

A single-group study can describe outcomes observed after participants receive the study intervention. It does not directly measure the outcome that the same population would have had under a different intervention. That unobserved alternative is the counterfactual that a comparative treatment-effect question requires. Random allocation between treatment groups can support a fairer comparison by balancing factors on average, but this study has no randomized comparison: allocation is NA, the model is SINGLE GROUP, and the record describes one treated arm. Therefore, its design cannot provide a direct estimate of the difference between SURGICEL Powder and another approach.

Masking is recorded as NONE. In general, masking can reduce the influence of knowledge about treatment on some assessments or decisions, depending on how an outcome is measured. Here, the registry does not describe a masking procedure. The endpoint includes assessment of bleeding at a surgical site, but the record does not provide details about who assessed it or how assessment procedures were standardized. Those details are not reported in the registry record.

Why does the event definition matter?

A clear event definition determines what counts as success and makes the outcome interpretable. In this study, absence of detectable bleeding at the specified assessment and no rebleeding requiring additional treatment before closure are both part of the primary definition. A result based only on the assessment at 5 minutes, without accounting for the rebleeding condition, would not be the same endpoint. The registry states the definition but not the observed number of subjects meeting it.

The primary population is described as Intent to Treat, including all subjects for whom a Target Bleeding Site was identified. The actual size of that population is not reported in the registry record. The overall enrollment is 103, but it should not be substituted for the primary analysis denominator without confirmation that every enrolled subject met the population definition and had an evaluable endpoint. The number with an identified site, the number assessed, and the handling of any unavailable endpoint observations are not reported.

How should the planning illustration be read?

The registry’s stated planning illustration is based on the observed effect, rather than the trial’s own design. Its described assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These assumptions describe an illustrative planning exercise, not observed trial results. The study itself is single-group, so the two-arm planning framework should not be confused with the design used to collect these data.

In general, a sample-size calculation describes how many participants might be needed under specified assumptions to detect a chosen effect with a target level of power. It is a planning quantity, not evidence that a study had that power after completion. The calculation’s participant requirements and the effect estimate used as its basis are not reported in the registry record. No observed-power conclusion can be drawn from the planning assumptions.

For time-to-event outcomes, the record says planning tables use the total number of events under the Schoenfeld method; other planning tables give participants per arm. The listed outcomes in this study are haemostatic-success assessments and adverse-event counts, not a reported time-to-event analysis. No further statistical analysis procedure, including methods for confidence intervals, is reported in the registry record.

What does over-dispersion mean in general?

For count data, a simple statistical model may assume that variability follows a particular distribution. Over-dispersion means the observed variability is greater than that model expects. If it is ignored, uncertainty estimates can be too small and statistical tests can appear more conclusive than warranted. This is a general concept; the registry information analyzed does not state that over-dispersion was assessed or that a count model was used for the primary endpoint.

The registry lists 6 outcome measures and 3 analyses, but those totals alone do not reveal the statistical procedures, covariate adjustments, rules for selecting analyses, or handling of missing observations. Such details are not reported in the registry record. Accordingly, no adjustment strategy, model specification, or inferential result should be inferred from the outcome and analysis counts.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("SURGICEL Powder")
n      <- c(103)
events <- c(90)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  SURGICEL Powder  103  90  87.4  79.4  93.1  79.6  92.5  79.6  92.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 6 outcome measures and 3 analyses. The primary endpoint is haemostatic success at 5 minutes, and haemostatic success at 3 minutes and 10 minutes is listed as secondary outcomes. The record does not explain whether or how statistical testing across outcomes or analyses was controlled for multiplicity. It does not report a hierarchy for interpreting outcomes, a multiplicity adjustment, or which analyses were designated as primary or secondary beyond the endpoint labels. Those details are not reported in the registry record.

Multiplicity matters in general when researchers make several statistical comparisons: the chance of finding at least one apparently notable result can increase as the number of tests increases. A prespecified strategy can clarify how multiple results should be interpreted. Since the registry information does not describe such a strategy or provide endpoint test results, readers cannot determine whether multiplicity affected the analysis or interpretation.

The primary population is defined as all subjects for whom a Target Bleeding Site was identified. The number meeting that definition is not reported. The record also does not report the endpoint denominator, whether any primary outcome observations were missing, or how missing observations were handled. Although post-operative follow-up was planned through discharge and at 30 days and 6 months, the number completing each follow-up and the treatment of unavailable follow-up information are not reported.

Enrollment of 103 should not automatically be treated as the number analyzed for every outcome. The endpoint-specific analysis population and missing-data procedures are not reported in the registry record. This limits evaluation of whether the reported safety counts or any endpoint results include all enrolled subjects, and prevents assessment of possible bias from incomplete assessment or follow-up.

12. 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: pyrexia (1.9%), heart rate irregular (1.0%), abdominal hernia (1.0%), constipation (1.0%), gastroduodenal haemorrhage (1.0%).

The registry reports 24 subjects with serious adverse events and 63 subjects with other adverse events; 103 were at risk in each category. It also reports 2 deaths. These are descriptive counts from the SURGICEL Powder group, not comparisons with an untreated or alternative-treatment group. The figures should be read as safety observations in this study rather than as estimates of excess risk attributable to the device.

The listed serious adverse-event terms are Pyrexia, 1.9%; Heart rate irregular, 1.0%; Abdominal hernia, 1.0%; Constipation, 1.0%; Gastroduodenal haemorrhage, 1.0%; and Ileus, 1.0%. These entries indicate the terms and percentages recorded in the registry. The record does not provide additional context for each event, such as timing, clinical course, or an assessment of relationship to the device. Those details are not reported in the registry record.

Adverse-event counts do not establish causation. In general, events occurring during a study may have varied causes, and a single-group study cannot determine from counts alone whether their frequency differs from what would occur under another treatment. The posted safety information does not report a comparative estimate or an attribution analysis. The registry also does not provide further detail about whether subjects could contribute to more than one adverse-event term, so the listed term percentages should not be added or treated as a total.

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

The record establishes that a prospective, single-group, post-market study of SURGICEL Powder was completed and describes a specific primary haemostatic endpoint. That endpoint concerns success at 5 minutes after application, with no rebleeding requiring additional treatment before final fascial closure. The record also describes secondary assessments at 3 and 10 minutes and post-operative follow-up through discharge, 30 days, and 6 months.

What it does not report is the observed primary endpoint result. Without the number meeting the success definition and the number assessed, readers cannot determine the reported success proportion or its precision. The endpoint definition is not itself an outcome result. The same caution applies to the secondary haemostatic outcomes: their labels are present, but their observed results are not reported in the registry record.

The single-group design does not establish what would have happened to comparable subjects under another method of bleeding control. There is no control group, and the study is not a randomized comparison. Thus, the record cannot support a direct comparative estimate for SURGICEL Powder versus conventional methods or another intervention. Any description of observed outcomes would remain a description of this treated study group, not proof of a comparative treatment effect.

The safety counts are also descriptive. Serious adverse events, other adverse events, and deaths are reported, but the registry information does not establish whether those events were caused by the device. Without a comparison group and reported attribution detail, the counts cannot resolve that question.

In general, statistical interpretation depends on both the estimated result and its uncertainty, as well as the design and outcome ascertainment. For this record, important result details—including the primary endpoint estimate, confidence interval, analysis procedures, and missing-data handling—are not reported in the registry record. The appropriate conclusion is therefore limited: the registry documents the study design, planned assessments, endpoint definition, and safety counts, but it does not supply enough outcome information to quantify the primary haemostatic result or make a comparative effectiveness claim.

14. Why This Trial Matters Statistically

This study illustrates why a registry record should be read for both its design and its actual reported results. The primary endpoint is described in specific terms, including the assessment time and the requirement that rebleeding requiring additional treatment not occur before final fascial closure. That clarity helps identify what the study intended to measure. Yet the observed count and proportion are not reported, so the endpoint definition cannot answer how often success occurred.

The study also highlights the distinction between describing an outcome and estimating a treatment effect. A prospective design can collect observations in a planned way, and the single-group results can describe the treated group. But the absence of a comparator means there is no direct within-study contrast to separate treatment differences from other influences on outcomes. This is a design limitation, not a statistical defect that can be fixed by interpreting a single-group proportion as comparative evidence.

Safety reporting raises a related interpretive issue. Counts of subjects with serious or other adverse events are useful descriptive information, but without attribution details or a comparator they do not establish causation or relative risk. The record’s safety figures and the primary efficacy endpoint answer different descriptive questions and should not be combined into a single claim about overall benefit or harm.

Finally, the registry lists multiple outcome measures and analyses but does not report the statistical plan, missing-data procedures, or multiplicity approach. These details are important to understanding how estimates were selected and how uncertainty was evaluated. The record therefore provides a useful example of how design, outcome definitions, and completeness of reporting jointly determine what conclusions can be drawn.

15. 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 most important limitation for interpreting the primary endpoint is that its observed result is not reported in the registry record. The number of subjects achieving haemostatic success at 5 minutes, the number evaluated, the resulting proportion, and a measure of precision are absent. The record therefore permits discussion of the endpoint definition but not quantification of the primary outcome.

The single-group design is another important limitation. There is no concurrent comparator, and no random allocation between treatments. This limits interpretation to the treated group and prevents a direct estimate of comparative effectiveness. Masking is recorded as NONE; additional information about outcome assessors or any standardized assessment procedures is not reported in the registry record.

The primary population is defined by identification of a Target Bleeding Site, but its size is not reported. Enrollment is listed as 103, but the record does not state how many enrolled subjects met the primary population definition, were assessed at the endpoint, or had missing endpoint information. The approach to missing data and the completeness of follow-up through discharge, 30 days, and 6 months are not reported.

The registry lists 6 outcome measures and 3 analyses, but does not describe the statistical plan, including methods for estimating uncertainty or handling multiplicity. It also does not report the results for the secondary haemostatic assessments. Safety information includes event counts and selected terms, but additional clinical context and event attribution are not reported. These limitations mean that the posted record offers only a partial basis for evaluating outcomes and their interpretation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects — NCT03762200.
• Registry record last updated 2021-07-26; status last verified 2021-07.
• Results first posted 2020-12-22.
• 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.

19. Record Summary

NCT03762200 is a completed, prospective, single-group, multicentre, multispecialty, post-market study of SURGICEL Powder in adults with mild or moderate parenchymal or soft tissue intraoperative bleeding. Enrollment is listed as 103; the recorded start date is 2018-11-26 and primary completion date is 2019-12-02. The study includes general, gynaecological, urological, and cardiothoracic surgery.

The primary endpoint is haemostatic success at 5 minutes after application, defined by no detectable bleeding at the Target Bleeding Site and no rebleeding requiring additional treatment before initiation of final fascial closure. Haemostatic success at 3 and 10 minutes is listed as secondary. The primary result is not reported in the registry record.

Safety counts include 24 subjects with serious adverse events, 63 with other adverse events, and 2 deaths. The registry does not establish event causation. There is no comparator arm, and statistical-plan, missing-data, and multiplicity details are not reported.