The Fibrin Patch Soft Tissue Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Fibrin Patch Soft Tissue Study (NCT00658723), a randomized phase 2 study. The primary outcome is Proportion of Subjects Achieving Hemostatic Success.

2. Clinical Question

The registry identifies this as a prospective, randomized, controlled, superiority evaluation. That wording states the direction of the research question; it is not itself evidence that superiority was established. The posted randomized-group results give the success proportion for each arm, but the registry record does not report a statistical test, confidence interval, or analysis estimate for the comparison. The size and precision of the difference between groups therefore cannot be assessed from an inferential result in the registry.

The record also lists a non-randomized Fibrin Pad group. Its result may describe outcomes among those participants, but it does not answer the randomized comparison on the same basis. The eligibility rules, reason for non-randomized participation, and relationship of this group to the randomized study population are not reported in the registry record. Consequently, the primary clinical question is best read as the randomized Fibrin Pad versus randomized SURGICEL comparison, not as a comparison involving all listed participants.

3. Trial Design

This was a Phase 2, randomized, parallel-group, controlled study with no masking. The registry describes its objective as evaluating whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgery for soft tissue bleeding. The intervention listing calls the treatment Fibrin Pad; the primary randomized arm is labelled Fibrin Pad - Randomized. The comparator is listed as SURGICEL™ and the randomized arm as SURGICEL.

The study record reports enrollment of 141 and a completed status. The recorded start is 2008-03 and primary completion is 2009-04. The posted primary results distinguish a randomized Fibrin Pad group with n=60.0, a randomized SURGICEL group with n=30.0, and a non-randomized Fibrin Pad group with n=51.0. These arm entries should not be treated as interchangeable: only the first two are explicitly labelled randomized. The registry does not report why the non-randomized group was included or how it was intended to contribute to the study objectives.

The primary endpoint was an intra-operative measure of hemostatic success. It combined hemostasis at 4 minutes after randomization with the absence of re-bleeding requiring treatment during a subsequent 6-minute observation period. The registry lists 8 outcome measures overall and 7 secondary outcomes, including hemostatic success, treatment failures, adverse events, re-treatment, and events potentially related to bleeding, thrombosis, or transfusion exposure.

The sponsor is Ethicon, Inc. Detailed information about sequence generation, allocation concealment, eligibility criteria, participant flow, surgical procedure mix, treatment application, protocol deviations, and the statistical analysis plan is not reported in the registry record. Randomization is stated, but the record does not describe how it was implemented. No masking was used, so the study was open-label as recorded; the record does not explain whether outcome assessment was independently blinded.

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: The efficacy results are based on the intent-to-treat (ITT) set, which is based on 90 randomized subjects from the two randomized arms - Fibrin Pad Randomized and SURGICEL(TM) Randomized. The Fibrin Pad Non-randomized arm was used for the safety analysis set.

Overall Study

Reasons for not completing this period:

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 Proportion of Subjects Achieving Hemostatic Success, measured over Intra-operative.

The primary endpoint is the proportion of subjects achieving hemostatic success during the operation. Success required hemostasis at 4 minutes after randomization and no re-bleeding requiring treatment during a subsequent 6-minute observation period. This definition makes the outcome a combined clinical criterion over a specified assessment window, rather than a measure of blood loss or time to hemostasis alone.

A binary success endpoint can be useful when the practical question is whether a prespecified hemostatic goal has been achieved. It translates each participant’s observed course into success or failure under the stated rule and allows the proportion meeting that rule to be compared between treatment groups. The timing and re-bleeding condition matter: a participant who initially achieves hemostasis but later needs treatment for re-bleeding would not meet the recorded definition.

The registry reports success as a percentage for each listed arm. The randomized Fibrin Pad arm is reported as 98.3% with n=60.0, and the randomized SURGICEL arm as 53.3% with n=30.0. The non-randomized Fibrin Pad arm is reported as 98.0% with n=51.0. These are descriptive arm results; the record does not post an uncertainty interval or inferential comparison for the primary endpoint.

Important details for interpreting this outcome are not reported in the registry record, including the number of participants with missing endpoint assessments, the handling of missing observations, the analysis population, and whether the endpoint was assessed by an independent reviewer. The registry also does not provide a more detailed operational definition of hemostasis beyond the stated timing and re-bleeding requirement.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes randomization, a parallel-group model, no masking, and a superiority objective. Those labels give a broad outline of the design, but they do not identify the statistical methods used to analyze the endpoint. No analyses are posted. The analysis plan, including the primary comparison method, handling of the endpoint, and any adjustment for covariates, is not reported in the registry record.

What a randomized comparison is intended to do

In general, random assignment aims to make treatment groups comparable, on average, with respect to factors that could influence outcomes. This supports a comparison of outcomes by assigned group, provided the analysis follows an appropriate plan and the randomization process is implemented as intended. The registry says the study was randomized, but does not report sequence generation, allocation concealment, or the analysis population. The available record therefore supports identifying the randomized arms, but not assessing those procedural details.

A parallel-group design assigns participants to a group whose outcomes are assessed alongside those in another group. It differs from a design in which each participant receives multiple treatments in sequence. The record identifies a parallel model and lists randomized Fibrin Pad and SURGICEL arms. It does not give further details on treatment assignment or participant flow. The separate non-randomized Fibrin Pad arm should be kept distinct when describing the randomized comparison.

How to interpret a proportion endpoint

A proportion summarizes the share of participants meeting a defined outcome. Here, the stated success rule combines achievement of hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. A comparison of proportions can be expressed using several statistical measures, such as a difference in proportions or a relative measure. The registry does not post a comparative estimate, so no such measure should be inferred from the arm percentages. Calculating one from rounded summary values would produce an unadjusted recalculation, not the sponsor’s analysis; the registry record provides no sponsor analysis to compare against.

General methods for comparing proportions may use an exact test, a large-sample approximation, or a regression model, depending on the design and analysis plan. The choice can affect the estimate, uncertainty interval, and test result, particularly when sample sizes or event distributions are limited. Which method was selected for this trial is not reported in the registry record. The reported percentages alone do not identify the method.

Precision and uncertainty

In general, an estimate is more informative when accompanied by a confidence interval that reflects sampling uncertainty under the chosen model. The interval does not capture every potential source of bias; for example, it does not automatically address missing outcome data, deviations from the protocol, or measurement problems. No confidence interval for the primary endpoint is posted. The absence of an interval means the precision of the treatment comparison cannot be evaluated from the registry’s primary results.

For a binary outcome, the amount of information depends on the number of participants assessed and on how outcomes are distributed. The randomized groups have different reported sample sizes, and no analysis is posted to show how that imbalance was handled. The record does not report endpoint denominators separately from the arm sizes, so it is not possible to confirm from the registry whether every randomized participant contributed to the displayed percentage.

Over-dispersion and model choice

General statistical explanation: over-dispersion occurs when observed variability is greater than a model assumes. It can make standard errors too small if a model does not account for the extra variability. This issue can arise in some clustered or count-data settings, but the primary endpoint is reported as a proportion, and the registry does not identify a model or report an over-dispersion assessment. It would be inappropriate to infer that such an issue was present or that a particular correction was used.

Planning assumptions are not observed evidence

Sample-size planning uses assumptions about the expected treatment effect, variability, significance level, allocation, and desired power to estimate how many participants might be needed. General planning illustrations are not observed power and do not establish what the trial was designed to detect. The registry does not report the trial’s sample-size justification, target power, or assumptions. It is therefore not possible to evaluate whether enrollment was selected to detect a specified effect. Any planning illustration should be understood as a hypothetical calculation, not as an observed trial result.

The registry also does not report interim analyses or stopping rules. Their presence or absence cannot be inferred from the completed status or from the posted endpoint values. Similarly, the absence of posted analysis results is not evidence that a particular test was or was not conducted outside the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists the primary endpoint and 7 secondary outcomes. The secondary outcomes cover hemostatic success, treatment failures, adverse events potentially related to bleeding, thrombotic events, or transfusion exposure, re-treatment, and adverse events more generally. The record lists 8 outcome measures overall. It does not post analyses for these outcomes, and no multiplicity procedure is reported in the registry record.

Multiplicity is a general statistical concern when several outcomes or comparisons are tested. As the number of statistical tests grows, the chance of obtaining at least one apparently notable result by chance can increase. Methods such as a prespecified hierarchy or adjustment can address particular multiplicity questions, but the suitable approach depends on the design and aims. This registry record does not describe whether any such strategy was planned or used. Because no analyses are posted, there are no reported secondary-outcome tests to interpret as confirmatory findings.

Missing-data information is also not reported in the registry record. The number of participants lacking an endpoint assessment, reasons for missingness, and method used to handle missing observations are not given. The record does not state whether the primary outcome denominator included all randomized participants or only those with an evaluable endpoint. Without those details, readers cannot assess how incomplete outcome data might affect the reported proportions.

The analysis populations are not reported in the registry record. In particular, the record does not specify whether the primary analysis followed an intention-to-treat principle, a per-protocol approach, or another definition. These approaches answer related but distinct questions, and deviations from assigned treatment can have different implications under each. The record also does not report protocol deviations or the number of participants analyzed for each outcome. These omissions limit assessment of the primary comparison as well as the secondary outcomes.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: postoperative ileus (10.0%), bronchopleural fistula (6.7%), dehydration (4.5%), pulmonary embolism (4.5%), leukocytosis (3.3%).

The registry reports serious-event figures for Fibrin Pad All and SURGICEL™ Randomized. For Fibrin Pad All, 111 were at risk and 40 were affected for the serious-event grouping; 111 were at risk and 105 were affected for the other-event grouping. For SURGICEL™ Randomized, 30 were at risk and 15 were affected for the serious-event grouping; 30 were at risk and 27 were affected for the other-event grouping. These are registry counts, not a randomized safety comparison adjusted for differences in group composition or follow-up.

The Fibrin Pad All category includes more than the randomized Fibrin Pad arm by its label and at-risk count, so it should not be read as the randomized treatment group alone. The registry does not provide a corresponding safety group labelled only Fibrin Pad - Randomized. It also does not report the follow-up period for the safety summaries, event adjudication procedures, or whether the affected counts represent participants with at least one event under a specified coding rule.

The listed top serious adverse-event terms are POSTOPERATIVE ILEUS (10.0%), BRONCHOPLEURAL FISTULA (6.7%), DEHYDRATION (4.5%), PULMONARY EMBOLISM (4.5%), LEUKOCYTOSIS (3.3%), and ACUTE MYOCARDIAL INFARCTION (3.3%). The registry does not identify the treatment-group attribution for these terms in the posted listing. Death values are not reported in the registry record. These figures should be read as descriptive safety reporting, not as evidence that an event was caused by a study treatment or as a basis for comparing randomized-group risk.

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

The registry’s primary results describe the proportion meeting a defined intra-operative success criterion. The reported value is 98.3% for the randomized Fibrin Pad arm and 53.3% for randomized SURGICEL; the non-randomized Fibrin Pad arm is reported as 98.0%. These are the posted arm-level values. They do not supply the uncertainty around the randomized comparison, because the registry does not post a confidence interval or inferential analysis.

The results do not by themselves establish whether the trial met its superiority objective. That conclusion would ordinarily require a prespecified statistical analysis, including the comparison measure and decision rule, together with an estimate and its uncertainty. Those details are not reported in the registry record. The study title and design description identify the planned question, but do not substitute for the analysis needed to answer it statistically.

The non-randomized arm offers a separate descriptive result and should not be treated as an additional randomized group. The registry does not report why these participants were non-randomized, how they were selected, or whether their clinical characteristics were comparable with those in the randomized arms. A similarity in observed percentage is not proof that the groups are exchangeable, nor does it establish that their results can be pooled.

The endpoint is specific to the stated intra-operative time window and success definition. It does not, by itself, summarize other clinical outcomes, longer-term results, or safety. The registry lists several secondary outcomes, but does not post analyses for them. Safety counts are descriptive and have limitations in group definition and attribution, including the Fibrin Pad All category and the absence of treatment attribution for the listed serious-event terms.

In short, the record supplies descriptive primary outcome values and selected safety summaries, but not a complete inferential assessment. It does not justify a claim about treatment effect certainty, statistical significance, or the causal attribution of adverse events. Those conclusions would require information and analyses not reported in the registry record.

13. Why This Trial Matters Statistically

This trial illustrates an important distinction in clinical-trial reporting: arm-level outcomes are not the same as a statistical comparison. A percentage describes what was recorded in a group, while a comparative estimate and uncertainty interval address how the groups differ under a stated method and how precisely that difference is estimated. The registry posts primary outcome percentages but no inferential analysis, leaving the comparative precision unresolved.

The distinction between randomized and non-randomized groups is also central. Randomization is the design feature intended to support a fair comparison between assigned groups. A separately listed non-randomized cohort may provide context, but it does not share the same basis for causal comparison. Keeping those populations separate prevents a descriptive result from being mistaken for randomized evidence.

The endpoint definition demonstrates why outcome details matter. Hemostatic success was not simply recorded as hemostasis at one instant: the definition also required no re-bleeding requiring treatment during the subsequent observation period. Readers need that operational rule to understand what the reported percentages mean and what kinds of events count as failures.

Finally, the record highlights the value of transparent reporting of analysis populations, missing data, multiplicity, and sample-size justification. These details help readers assess whether the analysis matches the design and whether the reported estimates can support the stated objective. Their absence does not erase the descriptive results, but it limits how far those results can be taken. Statistical interpretation depends not only on the observed values but also on knowing how they were defined, analyzed, and qualified.

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.

Several trial-specific limitations follow from the available registry record. Although randomization is stated, the method used to generate and conceal the allocation is not reported in the registry record. The record also does not describe participant eligibility in detail, baseline characteristics, surgical procedure distribution, or how the non-randomized Fibrin Pad group was assembled. These omissions limit evaluation of group comparability and the applicability of the results to particular surgical settings.

The primary endpoint is described, but details about endpoint ascertainment are not reported in the registry record. It is not stated whether assessment was standardized across sites or performed by an independent assessor. The trial was unmasked, and the record does not report whether any safeguards were used for outcome assessment. Because the endpoint involves determining hemostasis and whether re-bleeding required treatment, assessment procedures are relevant to interpretation.

The registry reports percentages and arm sample sizes, but does not report endpoint denominators, missing observations, analysis populations, or protocol deviations. It also does not post a confidence interval, statistical test, or comparative estimate. As a result, readers cannot assess the precision of the randomized comparison or determine whether the posted percentages include all randomized participants.

Safety summaries have their own constraints. The Fibrin Pad All category is distinct from the randomized Fibrin Pad arm, and the registry does not attribute the listed top serious-event terms to a treatment group. Follow-up duration, event adjudication, and details of the serious-event coding are not reported in the registry record. The counts therefore have limited value for direct randomized safety comparisons.

The registry also does not report the sample-size justification, interim analyses, stopping rules, or multiplicity approach. These absences prevent assessment of the planned precision and inferential framework. They should be treated as reporting limitations, rather than as evidence that any particular design or analysis procedure was used or omitted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Fibrin Patch Soft Tissue Study — NCT00658723.
• Registry record last updated 2014-09-11; status last verified 2014-09.
• Results first posted 2014-09-11.
• 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.

18. Record Summary

NCT00658723 is the registry record for The Fibrin Patch Soft Tissue Study, a completed Phase 2, randomized, parallel-group, unmasked superiority evaluation sponsored by Ethicon, Inc. The recorded study start is 2008-03, primary completion is 2009-04, and enrollment is 141. The study concerns adjunctive control of soft tissue bleeding during abdominal, pelvic, retroperitoneal, and non-cardiac thoracic surgery.

The primary endpoint is intra-operative hemostatic success, defined as hemostasis at 4 minutes after randomization without re-bleeding requiring treatment during a subsequent 6-minute observation period. The posted success values are 98.3% for randomized Fibrin Pad, 53.3% for randomized SURGICEL, and 98.0% for non-randomized Fibrin Pad. The registry lists 7 secondary outcomes and 8 outcome measures overall, but posts 0 analyses.

No inferential comparison, confidence interval, sample-size justification, missing-data method, or analysis-population definition is reported in the registry record. The posted outcome values are therefore descriptive, and the record does not establish the statistical precision of the randomized comparison.