This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for The EVICEL® Neurosurgery Phase III Study (NCT02457546), a randomized phase 3 study. The primary outcome is Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02457546 |
| Phase | Phase 3 |
| Condition | Cerebrospinal Fluid Leak |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 234 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ethicon, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People undergoing cranial surgery with sutured dural repair, in a study focused on cerebrospinal fluid leak. The primary endpoint is defined for the Per Protocol Set. The registry record reports enrollment of 234 participants, but the number included in that endpoint analysis is not reported in the registry record.
Intervention
EVICEL Fibrin Sealant (Human), used as an adjunct to sutured dural repair. The record describes EVICEL as a human plasma-derived fibrin sealant composed of thrombin and fibrinogen.
Comparator
A hydrogel sealant, also used as an adjunct to sutured dural repair. Its described components are a polyethylene glycol ester solution and a trilysine amine solution. In the adverse-event listing, the comparator group is labelled DuraSeal.
Primary question
How often did participants meet the registry’s definition of primary effectiveness success: no inter-operative cerebrospinal fluid leak following the Valsalva maneuver, and no cerebrospinal fluid leak or pseudomeningocele in the surgical area during the 30-day follow-up period? A single comparative result for this endpoint is not reported in the registry record.
The clinical question is about the use of a sealant alongside a sutured repair, rather than the sealant as a replacement for suturing. The endpoint joins an intraoperative observation with events assessed during follow-up. That makes it relevant to the study’s stated objective of evaluating EVICEL as an adjunct in cranial surgery, while also meaning that success depends on satisfying the full endpoint definition.
The registry identifies the study as randomized and controlled, with EVICEL compared against hydrogel sealant. It does not report a comparative estimate, uncertainty interval, or test result for the primary endpoint. Consequently, the registry record does not establish the size or precision of any difference between the groups.
3. Trial Design
The EVICEL Neurosurgery Phase III Study is recorded as a randomized, single-blinded, parallel-group, controlled study. Its stated objective was to evaluate the safety and effectiveness of EVICEL Fibrin Sealant (Human) as an adjunct to sutured dural repair in cranial surgery. The study condition is cerebrospinal fluid leak. Ethicon, Inc. is listed as the sponsor.
The registry reports enrollment of 234 participants. The study start date is 2015-07-01, the primary completion date is 2017-09-13, and the status is completed. The record does not report the numbers randomized to each group, the numbers analyzed for the primary endpoint, or how many participants completed follow-up.
The two interventions are EVICEL Fibrin Sealant and hydrogel sealant. EVICEL is described as a human plasma-derived sealant composed of thrombin and fibrinogen. The hydrogel sealant is described as composed of a polyethylene glycol ester solution and a trilysine amine solution. The adverse-event group labels use “Evicel” and “DuraSeal”; the comparator intervention description uses “Hydrogel sealant.”
Random allocation is intended, in general, to make groups comparable on average at the point of assignment. Single blinding means some study participants or personnel were masked, but which parties were masked and how masking was maintained are not reported in the registry record. The record identifies a parallel design, in which assigned groups are compared over the study rather than participants crossing from one intervention to another. Further details of allocation procedures, stratification, site structure, and treatment adherence are not reported in the registry record.
The primary endpoint description names the Per Protocol Set as its analysis population. That population label does not by itself explain the criteria for inclusion or how deviations and missing endpoint assessments were handled. Those operational details are not reported in the registry record. The record lists two outcome measures and one analysis, but its primary outcome information is not reduced to a single comparative result.
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 | Evicel | DuraSeal |
|---|---|---|
| STARTED | 114 | 120 |
| COMPLETED | 105 | 116 |
| NOT COMPLETED | 9 | 4 |
Reasons for not completing this period:
| Reason | Evicel | DuraSeal |
|---|---|---|
| Other reasons | 4 | 1 |
| Refused to complete study/procedures | 1 | 1 |
| Lost to Follow-up | 4 | 1 |
| Adverse Event | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol Set
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Baseline data was summarized for the intent to Treat (ITT) Set, which included all randomized subjects
| Characteristic | Unit | Evicel | DuraSeal | Total |
|---|---|---|---|---|
| Participants analysed | 114 | 120 | 234 | |
| Age, Continuous | years | 53.4 (SD 14.9) | 56.0 (SD 15.0) | 54.7 (SD 15.0) |
| Sex: Female, Male: Female | Participants | 59 | 59 | 118 |
| Sex: Female, Male: Male | Participants | 55 | 61 | 116 |
| Race/Ethnicity, Customized: White/Caucasian | Participants | 102 | 101 | 203 |
| Race/Ethnicity, Customized: Black or African American | Participants | 9 | 9 | 18 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 1 | 3 | 4 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 2 | 3 |
| Race/Ethnicity, Customized: Other | Participants | 1 | 4 | 5 |
| BMI | kg/m^2 | 27.5 (SD 6.0) | 26.9 (SD 5.0) | 27.2 (SD 5.5) |
| BMI (Grouped): Underweight | Participants | 1 | 1 | 2 |
| BMI (Grouped): Normal | Participants | 37 | 46 | 83 |
| BMI (Grouped): Overweight | Participants | 45 | 39 | 84 |
| BMI (Grouped): Obese | Participants | 27 | 34 | 61 |
| BMI (Grouped): Morbidly Obese | Participants | 4 | 0 | 4 |
| Ethnicity: Hispanic | Participants | 2 | 3 | 5 |
| Ethnicity: Non-Hispanic | Participants | 112 | 117 | 229 |
6. Primary Endpoint
The registry lists the primary outcome as Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period), measured over Intraoperatively through 30-day follow-up.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary effectiveness endpoint concerns success of the dural repair after use of a sealant adjunct. Success is defined as having no inter-operative cerebrospinal fluid leak following the Valsalva maneuver and no cerebrospinal fluid leak or pseudomeningocele in the surgical area during the 30-day follow-up period. The registry describes the endpoint as the proportion of subjects meeting that definition and lists the unit as participants.
This is a binary clinical outcome: a participant either meets the full success definition or does not. The definition combines an observation made during surgery with events assessed after surgery. In general, combining observations across the procedure and follow-up can reflect more than immediate closure alone, but interpretation depends on consistent assessment and complete follow-up. The assessment procedures and rules for handling uncertain or missing observations are not reported in the registry record.
The endpoint is used to address the study’s stated question about sealant effectiveness as an adjunct to sutured dural repair. A proportion can convey how commonly the defined outcome occurred within an analysis group. A comparison between groups would then describe the contrast in those proportions, with uncertainty indicating how precisely that contrast is estimated. However, a single primary-effectiveness comparison and its uncertainty are not reported in the registry record. The endpoint definition alone does not show how many participants succeeded in either group or whether the groups differed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of EVICEL fibrin sealant and hydrogel sealant, but it does not report a single comparative result for the primary effectiveness endpoint. In particular, it does not report group-specific success counts or proportions, an effect estimate, a confidence interval, or a p-value for that endpoint. The available endpoint description therefore identifies what the study intended to assess, not the observed comparative effectiveness result.
The outcome definition is clinically specific: success requires no inter-operative cerebrospinal fluid leak after the Valsalva maneuver and no cerebrospinal fluid leak or pseudomeningocele in the surgical area during the 30-day follow-up period. This gives the reader a clear description of the outcome being counted, but not the count itself. The primary endpoint is associated with the Per Protocol Set; its size and the number of participants with evaluable data are not reported in the registry record.
The record also flags that the primary outcome has several categories or time points and is not reduced to one comparison. That warning matters for interpretation: a reader should not treat the endpoint definition or the study’s completed status as evidence of a favorable result, nor infer a between-group contrast from the other registry entries. A result for one adverse event or a summary count of other events would not substitute for the primary endpoint analysis.
The adverse-event figures are descriptive counts. The registry lists serious adverse events affecting 32 of 114 participants in the Evicel group and 37 of 120 in the DuraSeal group. Other adverse events are listed for 103 of 114 and 109 of 120, respectively; deaths are listed as 3 and 2. These entries do not report a statistical comparison, adjusted analysis, or confidence interval. The counts alone do not establish whether an observed difference is due to treatment, chance, differences in follow-up, or other factors. Event categories can overlap, and the record does not say whether counts represent people with at least one event or event occurrences for every line of the listing.
Some serious-event terms are accompanied by percentages in the registry. These include pseudomeningocele at 7.5%, postoperative wound infection at 4.2%, convulsion at 4.2%, pneumonia at 3.5%, glioblastoma at 3.3%, and cerebrospinal fluid leakage at 2.6%. The record does not supply the details needed to interpret those percentages as comparative risks: group-specific denominators, event-specific comparative estimates, and uncertainty measures are not reported in the registry record. They should be read as listed event frequencies, not as evidence of a treatment effect.
In general, statistical interpretation requires the estimated contrast, its precision, and the analysis population to be considered together. Here, the registry record does not report the primary contrast or its precision, and its analysis population is named without the corresponding analyzed count. No conclusion about the magnitude or direction of a primary-effectiveness difference can be drawn from the registry information described.
9. Statistical Methods Explained
What does the endpoint estimate?
The endpoint is defined as a proportion of participants meeting a success rule. In general, a proportion expresses the frequency of an outcome within a defined group. For a randomized comparison, an effect estimate would describe the contrast between the groups using a chosen scale, such as a difference or ratio. The registry record does not report a primary comparative estimate on any scale, so no such contrast can be interpreted from the recorded information.
The success rule combines the absence of an intraoperative leak after a Valsalva maneuver with the absence of a leak or pseudomeningocele in the surgical area during the 30-day follow-up period. A composite rule can summarize several clinically relevant aspects in one endpoint, but a composite result does not show how each component contributed. Component-specific primary results are not reported in the registry record.
What would uncertainty describe?
In general, a confidence interval describes the range of effect estimates compatible with the observed data under the model and assumptions used. A narrow interval indicates greater precision than a wide interval, while an interval spanning values that imply different conclusions may leave substantial uncertainty. A p-value, in general, measures how compatible the observed data are with a specified null hypothesis under a statistical model; it is not the probability that the null hypothesis is true. Neither a confidence interval nor a primary-endpoint p-value is reported in the registry record.
Without an effect estimate and its uncertainty, the registry record cannot show how precisely the primary comparison was estimated. The total enrollment of 234 does not determine the precision on its own. Precision also depends on group allocation, the number with observed endpoint data, the frequency of success, and the analysis method. These details are not reported in the registry record for the primary analysis.
How should the design be understood?
Randomization is intended, in general, to reduce systematic differences between assigned groups at baseline. Its success in a particular trial cannot be evaluated from the design label alone; baseline characteristics and allocation details are not reported in the registry record. A parallel-group design compares assigned groups over the study period. Single blinding indicates masking of some parties, but the registry does not identify who was blinded. Masking can, in general, reduce some forms of bias in treatment delivery or outcome assessment, but its likely role cannot be evaluated without those details.
The endpoint is assigned to the Per Protocol Set. In general, a per-protocol analysis focuses on participants who meet prespecified requirements for protocol adherence. The exact requirements and the consequences of excluding participants are not reported in the registry record. Because exclusion after randomization can affect comparability, the analysis population and participant flow are important for interpreting any estimate. The record does not report a corresponding intention-to-treat result or explain how the Per Protocol Set was formed.
What do the planning assumptions mean?
The registry includes sample-size assumptions for planning illustrations based on an observed effect. They specify a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are described as participants per arm for 80% or 90% power; time-to-event illustrations are described as total event counts. These are planning illustrations, not observed power and not the study’s own design justification. The registry does not report a sample-size justification for the trial’s design.
In general, a planning sample size depends on the target effect, outcome variability or event frequency, significance level, desired power, allocation, and assumptions about missing data. If the effect used for planning is estimated from the trial itself, planning illustrations based on that effect should not be mistaken for independent confirmation of the result. The registry record does not report the primary comparative estimate needed to assess such illustrations in context.
What analysis details are absent?
The registry record does not report the statistical test or model for the primary endpoint, adjustment for covariates, confidence-interval method, handling of missing endpoint observations, or any interim analysis plan. It also does not report whether analyses were adjusted for multiple comparisons. These are distinct design and analysis choices; none should be inferred from the fact that the study was randomized or completed.
In general, over-dispersion is relevant when observed variability exceeds what a chosen statistical model expects, potentially making standard errors too small if ignored. That issue is more relevant to some count-data settings than to a binary endpoint analyzed as a proportion. The registry record does not report a model for the primary endpoint or evidence of an over-dispersion assessment, so no trial-specific conclusion on that topic is warranted.
Overall, the statistical information identifies the endpoint, its analysis population label, and planning assumptions, but does not provide the primary estimate or the details needed to reproduce or assess its analysis. The registry record does not report enough information to determine the statistical method used for the primary comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures and one analysis, and it flags that the primary outcome has several categories or time points and is not reduced to a single comparison. It does not report a multiplicity strategy, such as a hierarchy of outcomes, adjustment procedure, or prespecified rule for selecting among comparisons. Without such information, the record does not establish how any multiplicity was handled.
In general, testing several outcomes, time points, or subgroups can increase the chance of a nominally notable finding arising by chance. Methods to address this can include prespecifying a primary contrast, adjusting inference, or treating additional analyses as exploratory. Which approach was used in this study is not reported in the registry record. The absence of a reported strategy should not be interpreted as proof that no strategy existed.
The primary outcome description names the Per Protocol Set, but the record does not report the number analyzed, the number with missing outcome data, the reasons for missingness, or the method used to handle missing observations. It also does not report whether participants were excluded after randomization or how protocol deviations were addressed. Missingness can affect both the estimated event frequency and the comparability created by randomization, so these details matter when evaluating an analysis.
The registry does not report a separate intention-to-treat estimate for comparison with the Per Protocol result. It is therefore not possible to assess whether the conclusions are robust to analysis-population choices. The registry record also does not report imputation, sensitivity analyses, or other approaches for evaluating the effect of missing data. These omissions limit assessment of the analysis, but they do not establish how the investigators handled these issues outside the information recorded in the registry.
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 |
|---|---|---|---|
| Evicel | 32 | 114 | 28.1% |
| DuraSeal | 37 | 120 | 30.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Evicel | 3 of 114 |
| DuraSeal | 2 of 120 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Evicel | 103 of 114 |
| DuraSeal | 109 of 120 |
Most frequent serious adverse event terms
| Event term | Organ system | Evicel | DuraSeal |
|---|---|---|---|
| Pseudomeningocele | Injury, poisoning and procedural complications | 2 of 114 | 9 of 120 |
| Pneumonia | Infections and infestations | 4 of 114 | 3 of 120 |
| Postoperative wound infection | Infections and infestations | 2 of 114 | 5 of 120 |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 114 | 4 of 120 |
| Convulsion | Nervous system disorders | 1 of 114 | 5 of 120 |
| Cerebrospinal fluid leakage | Nervous system disorders | 3 of 114 | 1 of 120 |
| Headache | Nervous system disorders | 2 of 114 | 2 of 120 |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 114 | 1 of 120 |
| Neutropenia | Blood and lymphatic system disorders | 1 of 114 | 1 of 120 |
| Subdural haemorrhage | Injury, poisoning and procedural complications | 1 of 114 | 1 of 120 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Evicel | DuraSeal |
|---|---|---|---|
| Headache | Nervous system disorders | 37 of 114 | 54 of 120 |
| Constipation | Gastrointestinal disorders | 32 of 114 | 29 of 120 |
| Nausea | Gastrointestinal disorders | 32 of 114 | 29 of 120 |
| Procedural pain | Injury, poisoning and procedural complications | 19 of 114 | 19 of 120 |
| Vomiting | Gastrointestinal disorders | 20 of 114 | 14 of 120 |
| Hypertension | Vascular disorders | 12 of 114 | 12 of 120 |
| Incision site pain | Injury, poisoning and procedural complications | 11 of 114 | 12 of 120 |
| Dizziness | Nervous system disorders | 5 of 114 | 10 of 120 |
| Wound secretion | Injury, poisoning and procedural complications | 6 of 114 | 8 of 120 |
| Hypotension | Vascular disorders | 6 of 114 | 8 of 120 |
Serious events with the highest arm-level rate: pseudomeningocele (7.5%), postoperative wound infection (4.2%), convulsion (4.2%), pneumonia (3.5%), glioblastoma (3.3%).
The registry lists serious adverse events for the Evicel and DuraSeal groups. Serious adverse events are reported as affecting 32 of 114 participants in the Evicel group and 37 of 120 in the DuraSeal group. Other adverse events are listed as affecting 103 of 114 and 109 of 120, respectively. Deaths are listed as 3 and 2. These are registry counts, not adjusted comparisons.
The record also lists serious-event terms with percentages: pseudomeningocele, 7.5%; postoperative wound infection, 4.2%; convulsion, 4.2%; pneumonia, 3.5%; glioblastoma, 3.3%; and cerebrospinal fluid leakage, 2.6%. It does not report comparative estimates or uncertainty intervals for these terms. The denominator and group attribution for each percentage are not reported in the registry record.
In general, adverse-event counts describe what was recorded during a specified observation period; they do not, by themselves, show that an intervention caused an event. The registry record does not report the event-specific observation windows, severity definitions, relatedness assessments, or statistical comparisons needed for a fuller interpretation. Categories may overlap, so the listed counts should not be added to create a total or interpreted as mutually exclusive. The adverse-event entries also do not replace the missing comparative primary-effectiveness result.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed randomized Phase III study compared EVICEL fibrin sealant with hydrogel sealant as an adjunct to sutured dural repair in cranial surgery. It also defines a primary effectiveness endpoint involving intraoperative leakage and leakage or pseudomeningocele during the 30-day follow-up period. These details clarify the study question and the outcome the investigators intended to assess.
The record does not report a single comparative primary-endpoint result. It therefore does not show the observed success frequency in either group, the estimated difference between groups, or the precision of that estimate. The study’s enrollment and completed status do not fill that gap. Without the outcome data and analysis, the registry information cannot establish the direction or size of a primary-effectiveness difference.
The adverse-event counts describe events recorded in the registry, but they do not establish comparative safety. The entries lack the comparative estimates, uncertainty measures, and event-specific details needed to assess whether any apparent group difference is meaningful. The figures also cannot establish causation. They should be interpreted as descriptive registry information.
In general, a trial result is best understood by considering the prespecified question, analysis population, estimate, uncertainty, and completeness of follow-up together. Here, the outcome definition and Per Protocol Set label are reported, while the primary estimate, uncertainty, analyzed group sizes, and missing-data handling are not reported in the registry record. The absence of these details limits what can be concluded from the registry, but is not evidence that the investigators did not conduct further analyses.
Accordingly, the registry record supports a description of the trial design and endpoint, plus a cautious reading of the adverse-event listings. It does not support a conclusion about whether either sealant had better effectiveness or safety in this study.
13. Why This Trial Matters Statistically
This trial is statistically notable for a common interpretive distinction: a clearly stated endpoint is not the same as a reported treatment-effect estimate. The registry defines success using intraoperative and follow-up criteria, but does not provide one comparative primary-effectiveness result. Readers can identify the clinical question without being able to judge the observed group contrast or its precision.
The endpoint also illustrates how composite outcomes affect interpretation. Combining the absence of an intraoperative leak with the absence of later leakage or pseudomeningocele creates a single success definition, but a result for that composite would not by itself show which component drove the outcome. Component-level results are not reported in the registry record. This makes the endpoint definition important, while leaving the contribution of its elements unknown.
The named Per Protocol Set raises another general statistical issue: the population used for analysis can matter as much as the model used. A per-protocol analysis can be informative about participants meeting protocol requirements, but exclusions after randomization may change the balance created by random assignment. The record does not report the population counts, eligibility rules for analysis, or a complementary intention-to-treat result, so that issue cannot be evaluated for this study.
Finally, the record separates descriptive safety counts from inferential comparisons. Serious and other adverse-event counts are reported, but the registry does not provide comparative uncertainty or event-specific analytical details. This illustrates why raw counts should not be treated as evidence of a treatment effect. Overall, the study information shows how endpoint construction, analysis population, and reporting completeness shape what can be learned statistically from a clinical trial record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation of the registry record is that it does not report a single comparative primary-effectiveness result, despite describing the endpoint and naming the Per Protocol Set. Group-specific primary success counts, proportions, an effect estimate, and an uncertainty interval are not reported in the registry record. The direction and precision of a primary comparison therefore cannot be assessed.
The record does not report the number randomized to each arm or the number included in the primary analysis. It also does not report participant flow, follow-up completeness, missing endpoint data, protocol deviations, or the criteria defining the Per Protocol Set. These omissions prevent assessment of how the analyzed population relates to the randomized population and whether missing observations could affect the result.
The primary outcome is flagged as having several categories or time points and not being reduced to one comparison. The registry does not report how those categories or times were analyzed, whether comparisons were prioritized, or how multiplicity was addressed. The model, statistical test, confidence-interval method, and any covariate adjustment are not reported in the registry record.
The adverse-event information is also limited for comparative interpretation. Although group counts and selected term percentages are listed, event-specific denominators, observation windows, uncertainty estimates, and analysis methods are not reported. The adverse-event group label “DuraSeal” differs from the intervention description “Hydrogel sealant”; the record does not explain that labeling difference. These limitations concern interpretation of the registry record and do not establish what analyses or documentation may exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The EVICEL® Neurosurgery Phase III Study — NCT02457546.
- Registry record last updated 2019-01-10; status last verified 2019-01.
- Results first posted 2018-12-04.
- 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
The registry record describes a completed, randomized, single-blinded, parallel Phase III study sponsored by Ethicon, Inc. It enrolled 234 participants and compared EVICEL Fibrin Sealant with hydrogel sealant as an adjunct to sutured dural repair in cranial surgery. The study began on 2015-07-01, and primary completion is recorded as 2017-09-13.
The primary endpoint assesses success based on no inter-operative cerebrospinal fluid leak following the Valsalva maneuver and no cerebrospinal fluid leak or pseudomeningocele in the surgical area during the 30-day follow-up period. The named analysis population is the Per Protocol Set. A single comparative primary result, its precision, and details of missing-data handling are not reported in the registry record.
Descriptive adverse-event counts are listed for the Evicel and DuraSeal groups, alongside selected serious-event terms and percentages. The record does not provide the inferential detail needed to interpret those entries as comparative treatment effects.