At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 40 enrolled

Drug / intervention

EVICEL® Fibrin Sealant +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/NCT02227706

NCT02227706Phase 3Completed

Compare CT.gov

A Prospective, Randomized, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients

Ethicon, Inc.·interventional·Posted Aug 28, 2014·Updated Aug 31, 2020

In Brief

A Phase 3 clinical trial evaluating EVICEL® Fibrin Sealant and SURGICEL® Absorbable Hemostat for Hemorrhage and Soft Tissue Bleeding. Completed, enrolled 40 participants across 13 sites in 3 countries.

Detailed Summary

To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHemorrhage, Soft Tissue Bleeding

CountriesBelgium, Canada, United Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartAug 2014

First PostedAug 2014

Primary CompletionApr 2019

Study CompletionMay 2019

TodayJul 2026

First PostedAug 28, 2014

Enrollment StartAug 1, 2014

Primary CompletionApr 17, 2019

Study CompletionMay 17, 2019

TodayJul 2, 2026

Enrollment to primary: 4.7 yearsPosted 11.8 years ago

Interventions

EVICEL® Fibrin Sealantbiological

EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product

SURGICEL® Absorbable Hemostatdevice

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