Comparison · NCT02227992-cbbee2b8
EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants With Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants With Adverse Events. Trial comparisons, record NCT02227992-cbbee2b8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02227992-cbbee2b8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.9 | 0.699 | 0.972 | wilson | |
| Risk in group 2 | 0.9 | 0.699 | 0.972 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.214 | 0.214 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.813 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.127 | 7.89 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | EVARREST Sealant Matrix | Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). | 18 | 20 | OG000 |
| Group 2 | SURGICEL Absorbable Hemostat (Control) | Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. | 18 | 20 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events
- Description
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- Time frame
- Up to 44 days post-surgery on Day 0
- Population
- The safety analysis set consists of all participants who received treatment.
Source ClinicalTrials.gov
Trial
- Title
- The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
- NCT number
- NCT02227992
- Phases
- PHASE3
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Interventions
- EVARREST™ Sealant Matrix, SURGICEL®
- Lead sponsor
- Ethicon, Inc.
- Results first posted
- 2023-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02227992?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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