CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
EVARREST™ Sealant Matrix +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02227992
NCT02227992Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Paediatric Patients

Ethicon, Inc.·interventional·Posted Aug 28, 2014·Updated Sep 8, 2023

In Brief

A Phase 3 clinical trial evaluating EVARREST™ Sealant Matrix and SURGICEL® for Hemorrhage and 2 related conditions. Completed, enrolled 40 participants across 10 sites in 2 countries.

Detailed Summary

The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
CountriesBelgium, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 28, 2014
Enrollment StartJul 1, 2014
Primary CompletionOct 27, 2021
Study CompletionNov 12, 2021
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 11.8 years ago

Interventions

EVARREST™ Sealant Matrixbiological

EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.

SURGICEL®device

SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.